This clinical UM guideline 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 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.

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 designed to deliver drugs for up to five days followed by removal of the catheter.

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 role of these devices in the realm of postoperative pain management.  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 three 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).

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, (e.g., soft tissue, body cavity), perineural and percutaneous. The devices have not been FDA approved 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. According to the FDA Alert:

The significance of this injury to otherwise healthy young adults warrants notification to health care professionals. The local anesthetics (with and without epinephrine) were infused for extended periods of time (48 to 72 hours) directly into the intra-articular space using an elastomeric pump. Chondrolysis was diagnosed within a median of 8.5 months after the infusion.  Almost all of the reported cases of chondrolysis (97%) occurred following shoulder surgeries. Joint pain, stiffness, and loss of motion were reported as early as the second month after receiving the infusion. In more than half of these reports, the affected individuals required additional surgery, including arthroscopy or arthroplasty (joint replacement).  It is not known which specific factor or combination of factors contributed to the development of chondrolysis in these cases. The infused local anesthetic drugs, the device materials, and/or other sources may have resulted in the development of chondrolysis.  It is important to note that single intra-articular injections of local anesthetics in orthopedic procedures have been used for many years without any reported occurrence of chondrolysis.  Healthcare professionals are encouraged to follow the instructions for use of elastomeric infusion devices, and to not use these devices for continuous intra-articular infusion of local anesthetics after orthopedic surgery.  Based on the reported cases of chondrolysis, following continuous intra-articular infusion with local anesthetics, the FDA is requiring the drug manufacturers to update their product labels to warn healthcare professionals about this potential serious adverse effect. FDA is also exploring possible options for addressing the safety issues with the infusion devices (e.g., labeling changes, etc.) (FDA, updated 2010).

Peer Reviewed Publications:

1. Alford JW, Fadale PD. Evaluation of postoperative bupivacaine infusion for pain management after anterior cruciate ligament reconstruction. Arthroscopy. 2003; 19(8):855-861.
2. 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.
3. 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. 2010; 26(4):451-461.
4. 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.
5. 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.
6. 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.
7. Bianconi M, Ferraro L, Ricci R, et al. The pharmacokinetics and efficacy of ropivivacaine continuous wound instillation after spine fusion surgery. Anesth Analg. 2004; 98(1):166-172.
8. 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.
9. 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.
10. Chen DW, Hsieh PH, Huang KC, et al. Continuous intra-articular infusion of bupivacaine for post-operative pain relief after total hip arthroplasty: A randomized, placebo-controlled, double-blind study. Eur J Pain. 2010; 14(5):529-534.
11. 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.
12. 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.
13. 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.
14. 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.
15. 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.
16. 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.
17. 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.
18. 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.
19. 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.
20. 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.
21. 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.
22. 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.
23. 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.
24. 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.
25. 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.
26. Little K, Pillai A, Fazzi U, Storey N. Local anaesthetic infusion with elastomeric pump after arthroscopic subacromial decompression. Ann R Coll Surg Engl. 2007; 89(4):410-413.
27. 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.
28. 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.
29. 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.
30. 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.
31. 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.
32. 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.
33. Reeves M, Skinner MW.  Continuous intra-articular infusion of ropivacaine after unilateral total knee arthroplasty.  Anaesth Intensive Care. 2009; 37(6):918-922.
34. 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.
35. 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.
36. 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.
37. 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.
38. 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.
39. 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.

Government Agency, Medical Society, and Other Authoritative Publications:

1. 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.
2. 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.  Available at: http://www2.cochrane.org/reviews/en/ab006954.html.  Accessed on September 16, 2011.
3. Morrell SM. Use of intra-articular continuous infusion pumps and chondrotoxicity. American Academy of Orthopaedic Surgeons (AAOS).  AAOS  Now. 2008. The American Academy of Orthopaedic Surgeons: Rosemont, IL. Available at: http://www.aaos.org/news/aaosnow/dec08/clinical8.asp.  Accessed on September 15, 2011.
4. U.S. Food and Drug Administration (FDA) 510(k) Premarket notification database.  On-Q^® Painbuster System Summary of Safety and Effectiveness.  No. K063530. Rockville, MD:FDA.  January 26, 2007.  Available at:  http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063530.pdf.  Accessed on September 16, 2011.
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 on September 16, 2011.
6. U.S. Food and Drug Administration (FDA). Postmarket Drug Safety Alerts.  Information for Healthcare Professionals - Chondrolysis Reported with Continuously Infused Local Anesthetics (marketed as bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine and ropivacaine).  November 13, 2009; updated February 16, 2010.  Available at:   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders
   /DrugSafetyInformationforHeathcareProfessionals/ucm190302.htm.  Accessed on September 16, 2011.

Continuous Local Delivery of Analgesia to Operative Sites Using an Elastomeric Infusion Pump
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.