Clinical UM Guideline

This document addresses the use of the elastomeric infusion pump as a means of local delivery of analgesia to operative sites during the post-operative period. These pumps are designed to reduce post-operative pain, while limiting the systemic side effects of analgesia.

This document does not address the use of infused analgesia or anesthesia during an operative procedure.

Not Medically Necessary:

Continuous local delivery of analgesia to operative sites using an elastomeric infusion pump during the post-operative period is considered not medically necessary as a technique of postoperative pain control.

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Not Medically Necessary:

Local delivery of analgesia to operative sites is designed to reduce postoperative pain, while limiting systemic side effects of analgesia. Drug delivery can be regulated through the use of simple, disposable, elastomeric pumps filled with analgesics that are attached to a variety of catheters that provide continuous delivery of the drug to the surgical site. Catheters may contain multiple openings, so that the drug seeps into the operative wound all along its length, similar in concept to a “soaker” hose. Elastomeric infusion pumps are devices in which fluid containing various analgesic agents is held in a stretchable balloon reservoir, and pressure from the elastic walls of the balloon drives fluid delivery. These pumps are designed to deliver analgesic drugs directly to, or around, the operative site for up to five days postoperatively, after which time the catheter is removed.

Use of elastomeric pumps to deliver local analgesics has been investigated, to date, by studies that were primarily case series and other small studies of the following postoperative clinical situations:

• orthopedic procedures, such as repair of the anterior cruciate ligament;
• urology procedures, such as prostatectomy;
• plastic surgery procedures;
• obstetrical/gynecologic procedures, such as cesarean section;
• gastrointestinal surgery procedures, such as hemorrhoidectomy or gastric bypass;
• thoracic surgery procedures, such as thoracotomy;
• cardiovascular surgery procedures, such as sternotomy.

Evaluation of the medical necessity of continuous delivery of local analgesia using elastomeric pain pumps requires additional, well designed, large studies to determine and validate the clinically appropriate role of these devices in the realm of postoperative pain management. At present, such use is not considered in accordance with generally accepted standards of medical practice. While several randomized studies have reported reductions in narcotic requirements, most of these studies were small and failed to demonstrate statistically significant, superior clinical outcomes, in terms of reductions in need for opioid pain medications (Allen, 2009; Banerjee, 2008; Bray, 2007; Chen, 2010; Coghlan, 2009; Heller, 2008; Hoenecke, 2002; Kazmier, 2008; Nechleba, 2005; Oakley, 1998). Variances in the surgical procedures studied and the number of catheters utilized further confound the available trial results (Forastiere, 2008). Additional small studies have been insufficiently powered to demonstrate improvements from the local analgesic technique in all key outcome variables, such as time to endotracheal extubation, time to intensive care unit (ICU) discharge, etc. (Chiu, 2008; White, 2003). In addition, a placebo-related beneficial effect has been noted in studies of local infusion of analgesics to multiple surgical sites (Alford and Fadale, 2003; Baroody, 2004; Schurr, 2004). A meta-analysis was conducted by Richman which evaluated data from available randomized controlled trials to determine the efficacy of perineural catheters for reducing postoperative pain, opioid-related side effects, (e.g., nausea, vomiting, sedation) and opioid use, compared with opioid analgesia alone. The level of individual satisfaction was also assessed. Although the results showed better postoperative analgesia from use of the perineural catheters, compared to opioids (p<0.001) for all catheter locations and time periods (p<0.05), lack of consistency was noted in the analgesic regimens reviewed across the various included trials (Richman, 2006).

Another study reported on a continuous wound infusion of ropivacaine in conjunction with best practice postoperative analgesia after midline laparotomy for abdominal colorectal surgery. The investigators performed a randomized, participant and outcome assessor-blinded, placebo-controlled trial on subjects presenting for major abdominal colorectal surgery. Subjects were allocated to receive ropivacaine 0.54 percent or normal saline via a dual catheter continuous infusion device into their midline laparotomy wound for 72 hours postoperatively. A total of 310 trial participants were included in this study. The investigators found that the continuous wound infusion of ropivacaine after abdominal colorectal surgery conveyed minimal benefit, compared with saline wound infusion with no statistically significant difference for: pain at rest, morphine usage, length of stay, mobility, nausea, or return of bowel function. There was a small, statistically significant difference in mean pain on movement on day 1 for the ropivacaine group (adjusted mean difference -0.6 [range, -1.08 to -0.13]). The investigators reported that, although this trend continued on days 2 and 3, the differences between groups were no longer statistically significant. The investigators concluded that delivery of ropivacaine to midline laparotomy wounds did not demonstrate any significant clinical advantage over current best practice (Polglase, 2007).

A single-institution, prospective, randomized, double-blinded study of 96 post-appendectomy subjects sought to evaluate the analgesic efficacy and safety of ropivacaine (0.2%), when administered continuously via elastomeric pump. Study subjects were randomly assigned into two groups: 500 mg of ropivacaine in 48 hours (10 mL of 0.2% ropivacaine 20 mg, starter dose plus 5 mL/h continuous wound infusion via elastomeric pump device; n=48) in the experimental group and 250 mL of normal saline, as placebo, in the control group. Postoperative pain was measured either with a simple verbal scale or with a visual analog scale; also parenteral analgesic consumption and global satisfaction scores were measured. A reduction in postoperative pain was observed in the ropivacaine group. The perceived degree of pain was assessed with a simple verbal scale measurement of severe and unbearable, with findings which were significantly lower in the ropivacaine group than in the normal saline group from time 0 to 24 hours at rest and from time 0 to 36 hours on coughing. Significantly lower pain intensity (visual analog scale) was found in the ropivacaine group both at rest and on coughing, beginning at 3 hours and continuing to 36 hours postoperatively (p<0.05), and the mean number of rescue analgesic doses was significantly lower in the ropivacaine group (p<0.001). There were no statistically significant differences in the frequency of adverse events between the two groups. The authors concluded that wound instillation with ropivacaine 0.2% is a useful, practical, and safe method for management of postoperative pain after appendectomy (Ansaloni, 2007).

A study completed by Goldsby and colleagues (2021) evaluated the effectiveness of continuous infusion of local anesthetics (CILA) in kidney donors after laparoscopic nephrectomy. A retrospective analysis was conducted on 176 sample subjects: 88 in the standard of care (SOC) post-operative analgesia group and 88 in the CILA group. The primary outcome was the total mean oral morphine equivalents administered after surgery. In the CILA group, the total oral morphine equivalents were higher than in the SOC group: 194.8 versus 133.5 mg (P=0.003). The total of postoperative administration of acetaminophen was also higher in the CILA group than in the SOC group at 48 hours: 2464.1 versus 1932.1mg (P=0.043). The total length of stay following surgery was longer in the CILA group than in the SOC group. The time to ambulation and return of bowel functions was not significantly different between the two groups. The authors concluded that CILA did not reduce the use of opioids as compared with SOC and does not improve patient outcomes in individuals who have undergone laparoscopic donor nephrectomy.

Several elastomeric pumps and associated catheters have received clearance through the U.S. Food and Drug Administration (FDA) 510(k) approval process as Class II devices. FDA-approved devices include, but are not limited to, the ON-Q^®, PainBuster^™, C-bloc^® and Homepump Eclipse^® (all from I-Flow Corporation, Lake Forest, CA), as well as the Stryker^® (Stryker, Kalamazoo, MI) and Accufuser^™ (McKinley Medical, Wheat Ridge, CO). FDA labeling indicates that these devices are generally intended for continuous and/or intermittent delivery of local anesthetics or narcotics to surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. The devices are, “Intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic-only pain management” (FDA, 2004). Several versions include individual-controlled bolus dosing features, which allow for the delivery of fixed bolus dose volumes of medication at fixed time intervals. Approved routes of administration are intraoperative, (for example, soft tissue, body cavity), perineural and percutaneous. The devices have not been cleared by the FDA for intra-articular use (FDA, 2009).

On November 13, 2009 the FDA issued a safety alert regarding 35 reports of chondrolysis (necrosis and destruction of cartilage) in individuals given continuous intra-articular infusions of local anesthetics with elastomeric infusion devices to control post-surgical pain. However, this FDA Alert has been archived on the FDA website and not updated with any further information.

On May 8, 2012 the FDA announced a Class I recall of the I-Flow ON-Q pump with ONDEMAND bolus button which was voluntarily recalled by the manufacturer, I-Flow Corporation (Lake Forest, CA), due to a flaw in the bolus button locking mechanism. The recall stated, “While no injuries or adverse events have been reported, use of a pump with this condition may result in over medication of the patient and may potentially result in serious patient injury.” According to the FDA, “Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death” (FDA, 2012). The manufacturer claims to be working to resolve this flaw in the pump mechanism, and on May 8, 2012 the manufacturer issued a “Voluntary Recall Notice” to its customers regarding the I-Flow ON-Q pump device with instructions for product return and customer credit. Additional Class II recalls had been issued by the FDA in 2007 for the I-Flow ON-Q with ONDEMAND feature and for the I-Flow ON-Q PainBuster with ONDEMAND feature for the same bolus button malfunction related to misassembly. According to the FDA, “Class II recalls are situations where use of, or exposure to, a volatile product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote” (FDA, 2009).

Adverse Event Reports have also been issued by the FDA for the I-Flow PainBuster infusion pump system related to chondrolysis of the shoulder (FDA, 2009), as well as for other pump systems, including the Stryker pump (FDA, 2008) and the Accufuser pain pump (FDA, 2011), related to leakages. Additional information, related to chondrolysis associated with intra-articular infusions of local anesthetics using an elastomeric pump following arthroscopic and other surgical procedures, is contained in the FDA labeling for ropivacaine hydrochloride (HCL) injection, USP (Aurobindo Pharma Limited IDA, Pashamylaram, India) and other formulations, such as Carbocaine^™ (mepivacaine HCLinjection USP) and bupivacaine HCL injection USP. It is noted that these medications are not approved for intra-articular infusions. There is no effective treatment for chondrolysis. According to the FDA label, adverse event reports have been submitted regarding the incidence of chondrolysis, which has primarily involved the shoulder joint, in pediatric and adult cases following intra-articular infusions of local anesthetics with and without epinephrine for periods of 48 to 72 hours and have required additional diagnostic and therapeutic procedures (including arthroscopy and joint replacement).

Peer Reviewed Publications:

1. Aguirre J, Baulig B, Dora C, et al. Continuous epicapsular ropivacaine 0.3% infusion after minimally invasive hip arthroplasty: a prospective, randomized, double-blinded, placebo-controlled study comparing continuous wound infusion with morphine patient-controlled analgesia. Anesth Analg. 2012; 114(2):456-461.
2. Alford JW, Fadale PD. Evaluation of postoperative bupivacaine infusion for pain management after anterior cruciate ligament reconstruction. Arthroscopy. 2003; 19(8):855-861.
3. Allen MS, Halgren L, Nichols FC 3rd, et al. A randomized controlled trial of bupivacaine through intracostal catheters for pain management after thoracotomy. Ann Thorac Surg. 2009; 88(3):903-910.
4. Andersen KV, Bak M, Christensen BV, et al. A randomized, controlled trial comparing local infiltration analgesia with epidural infusion for total knee arthroplasty. Acta Orthop. 2010a; 81(5):606-10.
5. Anderson SL, Buchko JZ, Taillon MR, Ernst MA. Chondrolysis of the glenohumeral joint after infusion of bupivacaine through an intra-articular pain pump catheter: a report of 18 cases. Arthroscopy. 2010b; 26(4):451-461.
6. Ansaloni L, Agnoletti V, Bettini D, et al. The analgesic efficacy of continuous elastomeric pump ropivacaine wound instillation after appendectomy. J Clin Anesth. 2007; 19(4):256-263.
7. Apelt N, Schaffzin J, Bates C, et al. Surgical site infection related to use of elastomeric pumps in pectus excavatum repair. Lessons learned from root cause analysis. J Pediatr Surg. 2017; 52(8):1292-1295.
8. Banerjee SS, Pulido P, Adelson WS, et al. The efficacy of continuous bupivacaine infiltration following arthroscopic rotator cuff repair. Arthroscopy. 2008; 24(4):397-402.
9. Baroody M, Tameo MN, Dabb RW. Efficacy of the pain pump catheter in immediate autologous breast reconstruction. Plast Reconstr Surg. 2004; 114(4):895-898.
10. Baulig W, Maurer K, Theusinger OM, et al. Continuous elastomeric pump-based ropivacaine wound instillation after open abdominal aortic surgery: how reliable is the technique? Heart Surg Forum. 2011; 14(1):E51-E58.
11. Bianconi M, Ferraro L, Ricci R, et al. The pharmacokinetics and efficacy of ropivacaine continuous wound instillation after spine fusion surgery. Anesth Analg. 2004; 98(1):166-172.
12. Boss AP, Maurer T, Seiler S, et al. Continuous subacromial bupivacaine infusion for postoperative analgesia after open acromioplasty and rotator cuff repair: Preliminary results. J Shoulder Elbow Surg. 2004; 13(6):630-634.
13. Bray DA Jr, Nguyen J, Craig J, et al. Efficacy of a local anesthetic pain pump in abdominoplasty. Plast Reconstr Surg. 2007; 119(3):1054-1059.
14. Buchko JZ, Gurney-Dunlop T, Shin JJ. Knee chondrolysis by infusion of bupivacaine with epinephrine through an intra-articular pain pump catheter after arthroscopic ACL reconstruction. Am J Sports Med. 2015; 43(2):337-344.
15. Chen DW, Hsieh PH, Huang KC, et al. Continuous intra-articular infusion of bupivacaine for post-operative pain relief after total hip arthroplasty:aA randomized, placebo-controlled, double-blind study. Eur J Pain. 2010; 14(5):529-534.
16. Cheong WK, Seow-Choen F, Eu KW, et al. Randomized clinical trial of local bupivacaine perfusion versus parenteral morphine infusion for pain relief after laparotomy. Br J Surg. 2001; 88(3):357-359.
17. Chiu KM, Wu CC, Wang MJ, et al. Local infusion of bupivacaine combined with intravenous patient-controlled analgesia provides better pain relief than intravenous patient-controlled analgesia alone in patients undergoing minimally invasive cardiac surgery. J Thorac Cardiovasc Surg. 2008; 135(6):1348-1352.
18. Chopra A, Hurren J, Szpunar S, Edwin SB. Assessment of postoperative pain control with an elastomeric pain pump following cardiothoracic surgery. Pain Med. 2017; 18(8):1450-1454.
19. Ciccone WJ 2nd, Busey TD, Weinstein DM, et al. Assessment of pain relief provided by interscalene regional block and infusion pump after arthroscopic shoulder surgery. Arthroscopy. 2008; 24(1):14-19.
20. Coghlan JA, Forbes A, McKenzie D, et al. Efficacy of subacromial ropivacaine infusion for rotator cuff surgery. A randomized trial. J Bone Joint Surg Am. 2009; 91(7):1558-1567.
21. Cohen AR, Smith AN, Henriksen BS. Postoperative opioid requirements following Roux-en-Y gastric bypass in patients receiving continuous bupivacaine through a pump system: a retrospective review. Hosp Pharm. 2013; 48(6):479-483.
22. Corso OH, Morris RG, Hewett PJ, Karatassas A. Safety of 96-hour incision-site continuous infusion of ropivacaine for postoperative analgesia after bowel cancer resection. Ther Drug Monit. 2007; 29(1):57-63.
23. Dauri M, Polzoni M, Fabbi E, et al. Comparison of epidural, continuous femoral block and intraarticular analgesia after anterior cruciate ligament reconstruction. Acta Anaesthesiol Scand. 2003; 47(1):20-25.
24. Dauri M, Sidiropoulou T, Fabbi E, et al. Efficacy of continuous femoral nerve block with stimulating catheters versus nonstimulating catheters for anterior cruciate ligament reconstruction. Reg Anesth Pain Med. 2007; 32(4):282-287.
25. Dobrydnjov I, Anderberg C, Olsson C, et al. Intraarticular vs. extraarticular ropivacaine infusion following high-dose local infiltration analgesia after total knee arthroplasty: a randomized double-blind study. Acta Orthop. 2011; 82(6):692-698.
26. Forastiere E, Sofra M, Giannarelli D, et al. Effectiveness of continuous wound infusion of 0.5% ropivacaine by On-Q pain relief system for postoperative pain management after open nephrectomy. Br J Anaesth. 2008; 101(6):841-847.
27. Fredman B, Zohar E, Tarabykin A, et al. Bupivacaine wound instillation via an electronic patient-controlled analgesia device and a double-catheter system does not decrease postoperative pain or opioid requirements after major abdominal surgery. Anesth Analg. 2001; 92(1):189-193.
28. Givens VA, Lipscomb GH, Meyer NL. A randomized trial of postoperative wound irrigations with local anesthetic for pain after cesarean delivery. Am J Obstet Gynecol. 2002; 186(6):1188-1191.
29. Goldsby J, Schwarz K, Kim I, et al. An Evaluation of the Effect of Catheter-Directed Continuous Infusion of Local Anesthetic by Elastomeric Pump on Opioid Usage Following Donor Kidney Nephrectomy. Ann Pharmacother. 2022 Feb;56(2):146-150.
30. Gupta A, Perniola A, Axelsson K, et al. Postoperative pain after abdominal hysterectomy: a double-blind comparison between placebo and local anesthetic infused intraperitoneally. Anesth Analg. 2004; 99(4):1173-1179.
31. Heller L, Kowalski AM, Wei C, Butler CE. Prospective, randomized, double-blind trial of local anesthetic infusion and intravenous narcotic patient-controlled anesthesia pump for pain management after free TRAM flap breast reconstruction. Plast Reconstr Surg. 2008; 122(4):1010-1018.
32. Hoenecke HR, Pulido PA, Morris BA, Fronek J. The efficacy of continuous bupivacaine infiltrations following anterior cruciate ligament reconstruction. Arthroscopy. 2002; 18(8):854-858.
33. Kainu JP, Sarvela J, Halonen P, et al. Continuous wound infusion with ropivacaine fails to provide adequate analgesia after caesarean section. Int J Obstet Anesth. 2012; 21(2):119-124.
34. Kazmier FR, Henry SL, Christiansen D, Puckett CL. A prospective, randomized, double-blind, controlled trial of continuous local anesthetic infusion in cosmetic breast augmentation. Plast Reconstr Surg. 2008; 121(3):711-715.
35. LeBlanc KA, Bellanger D, Rhynes VK, Hausmann M. Evaluation of continuous infusion of 0.5% bupivacaine by elastomeric pump for postoperative pain management after open inguinal hernia repair. J Am Coll Surg. 2005; 200(2):198-202.
36. Little K, Pillai A, Fazzi U, Storey N. Local anesthetic infusion with elastomeric pump after arthroscopic subacromial decompression. Ann R Coll Surg Engl. 2007; 89(4):410-413.
37. Liu SS, Richman JM, Thirlby RC, Wu CL. Efficacy of continuous wound catheters delivering local anesthetic for postoperative analgesia: a quantitative and qualitative systematic review of randomized controlled trials. J Am Coll Surg. 2006; 203(6):914-932.
38. Loane H, Preston R, Douglas MJ, et al. A randomized controlled trial comparing intrathecal morphine with transversus abdominis plane block for post-cesarean delivery analgesia. Int J Obstet Anesth. 2012; 21(2):112-118.
39. Matsen FA 3rd, Papadonikolakis A. Published evidence demonstrating the causation of glenohumeral chondrolysis by postoperative infusion of local anesthetic via a pain pump. J Bone Joint Surg Am. 2013; 95(12):1126-1134.
40. Medbery RL, Chiruvella A, Srinivasan J, et al. The value of continuous wound infusion systems for postoperative pain control following laparoscopic Roux-en-Y gastric bypass: an analysis of outcomes and cost. Obes Surg. 2014; 24(4):541-548.
41. Morgan SJ, Jeray KJ, Saliman LH, et al. Continuous infusion of local anesthetic at iliac crest bone-graft sites for postoperative pain relief. A randomized, double-blind study. J Bone Joint Surg Am. 2006; 88(12):2606-2612.
42. Nechleba J, Rogers V, Cortina G, Cooney T. Continuous intra-articular infusion of bupivacaine for postoperative pain following total knee arthroplasty. J Knee Surg. 2005; 18(3):197-202.
43. Noyes FR, Fleckenstein CM, Barber-Westin SD. The development of postoperative knee chondrolysis after intra-articular pain pump infusion of an anesthetic medication: a series of twenty-one cases. J Bone Joint Surg Am. 2012; 94(16):1448-1457.
44. Oakley MJ, Smith JS, Anderson JR, et al. Randomized placebo-controlled trial of local anesthetic in day-case inguinal hernia repair. Br J Surg. 1998; 85(6):797-799.
45. O'Neill P, Duarte F, Ribeiro I, et al. Ropivacaine continuous wound infusion versus epidural morphine for postoperative analgesia after cesarean delivery: a randomized controlled trial. Anesth Analg. 2012; 114(1):179-185.
46. Parker RD, Streem K, Schmitz L, Martineau PA.; Marguerite Group. Efficacy of continuous intra-articular bupivacaine infusion for postoperative analgesia after anterior cruciate ligament reconstruction: a double-blinded, placebo-controlled, prospective, and randomized study. Am J Sports Med. 2007; 35(4):531-536.
47. Polglase AL, McMurrick PJ, Simpson PJ, et al. Continuous wound infusion of local anesthetic for the control of pain after elective abdominal colorectal surgery. Dis Colon Rectum. 2007; 50(12):2158-2167.
48. Reeves M, Skinner MW. Continuous intra-articular infusion of ropivacaine after unilateral total knee arthroplasty. Anaesth Intensive Care. 2009; 37(6):918-922.
49. Richman JM, Liu SS, Courpas G, et al. Does continuous peripheral nerve block provide superior pain control to opioids? A meta-analysis. Anesth Analg. 2006; 102(1):248-257.
50. Rosseland LA, Helgesen KG, Breivik H, Stubhaug A. Moderate-to-severe pain after knee arthroscopy is relieved by intraarticular saline: A randomized controlled trial. Anesth Analg. 2004; 98(6):1546-1551.
51. Scheffel PT, Clinton J, Lynch JR, et al. Glenohumeral chondrolysis: a systematic review of 100 cases from the English language literature. J Shoulder Elbow Surg. 2010; 19(6):944-949.
52. Schurr MJ, Gordon DB, Pellino TA, Scanlon TA. Continuous local anesthetic infusion for pain management after outpatient inguinal herniorrhaphy. Surgery. 2004; 136(4):761-769.
53. Sherwinter DA, Ghaznavi AM, Spinner D, et al. Continuous infusion of intraperitoneal bupivacaine after laparoscopic surgery: a randomized controlled trial. Obes Surg. 2008; 18(12):1581-1586.
54. Williams BA, Kentor ML, Irrgang JJ, et al. Nausea, vomiting, sleep, and restfulness upon discharge home after outpatient anterior cruciate ligament reconstruction with regional anesthesia and multimodal analgesia/antiemesis. Reg Anesth Pain Med. 2007; 32(3):193-202.
55. Wu CC, Bai CH, Huang MT, et al. Local anesthetic infusion pump for pain management following open inguinal hernia repair: a meta-analysis. Int J Surg. 2014; 12(3):245-250.
56. Zhang Y, Lu M, Chang C. Local anesthetic infusion pump for pain management following total knee arthroplasty: A meta-analysis. BMC Musculoskelet Disord. 2017; 18(1):32.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Apfelbaum JL, Ashburn MA, Connis RT, et al. American Society of Anesthesiologists (ASA). Practice Guidelines for Acute Pain Management in the Perioperative Setting: An Updated Report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012; 116(2):248-273.
2. Acevedo Prado A, Atenzia Marino G. Local anesthetic infusion system for surgical wounds [summary]. Technical Consultation. CT2008/01. Santiago de Compostela, Spain: Galician Agency for Health Technology Assessment (AVALIA-T); 2008.
3. Bamigboye AA, Hofmeyr GJ. Local anesthetic wound infiltration and abdominal nerves block during caesarean section for postoperative pain relief. Cochrane Database of Syst Rev. 2009;(3):CD006954.
4. Naropin^® (ropivacaine HCL) [Product Information]. Lake Zurich, IL. Fresenius Kabi, USA/LLC. November 2, 2018. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020533s035lbl.pdf. Accessed onJuly 5, 2024.
5. U.S. Food and Drug Administration (FDA) 510(k) Premarket notification database. Infusor^™ SV and LV Elastomeric Infusion System Summary of Safety and Effectiveness. No. K071222. Rockville, MD: FDA. May 25, 2007. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf7/K071222.pdf. Accessed onJuly 5, 2024.

Continuous Local Delivery of Analgesia to Operative Sites Using an Elastomeric Infusion Pump
Infusor SV and LV Elastomeric Infusion Devices
On-Q Post Op Pain Relief System
On-Q Soaker^™
Pain Buster Pain Management System

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Federal and State law, as well as contract language including definitions and specific coverage provisions/exclusions, and Medical Policy take precedence over Clinical UM Guidelines and must be considered first in determining eligibility for coverage. The member's contract benefits in effect on the date that services are rendered must be used. Clinical UM Guidelines, which address medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Clinical UM Guidelines periodically. Clinical UM guidelines are used when the plan performs utilization review for the subject. Due to variances in utilization patterns, each plan may choose whether or not to adopt a particular Clinical UM Guideline. To determine if review is required for this Clinical UM Guideline, please contact the customer service number on the back of the member's card.