Liposomal Bupivacaine in One-level Instrumented Posterior Spinal Fusion

Summary

This study will describe postoperative pain management for spine surgery patients receiving liposomal bupivacaine (Exparel®) compared to patients not receiving the drug.

Timeline

Start

2019-01-26

Primary completion

2021-09-20

Completion

2028-08

Outcome

Outcome not reported

Stopped (Enrollment): “Lack of enrollment”

Publications

• Background Vaishya R, Wani AM, Vijay V. Local Infiltration Analgesia reduces pain and hospital stay after primary TKA: randomized controlled double blind trial. Acta Orthop Belg. 2015 Dec;81(4):720-9.
• Background Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003 Aug;97(2):534-540. doi: 10.1213/01.ANE.0000068822.10113.9E.
• Background Dias AS, Rinaldi T, Barbosa LG. The impact of patients controlled analgesia undergoing orthopedic surgery. Braz J Anesthesiol. 2016 May-Jun;66(3):265-71. doi: 10.1016/j.bjane.2013.06.023. Epub 2015 Apr 17.
• Background McBeath DM, Shah J, Sebastian L, Sledzinski K. The effect of patient controlled analgesia and continuous epidural infusion on length of hospital stay after total knee or total hip replacement. CRNA. 1995 Feb;6(1):31-6.
• Background Chahar P, Cummings KC 3rd. Liposomal bupivacaine: a review of a new bupivacaine formulation. J Pain Res. 2012;5:257-64. doi: 10.2147/JPR.S27894. Epub 2012 Aug 14.
• Background Barrington JW, Olugbode O, Lovald S, Ong K, Watson H, Emerson RH Jr. Liposomal Bupivacaine: A Comparative Study of More Than 1000 Total Joint Arthroplasty Cases. Orthop Clin North Am. 2015 Oct;46(4):469-77. doi: 10.1016/j.ocl.2015.06.003. Epub 2015 Aug 6.
• Background Cherian JJ, Barrington J, Elmallah RK, Chughtai M, Mistry JB, Mont MA. Liposomal Bupivacaine Suspension, Can Reduce Length of Stay and Improve Discharge Status of Patients Undergoing Total Hip Arthroplasty. Surg Technol Int. 2015 Nov;27:235-9.
• Background Chughtai M, Cherian JJ, Mistry JB, Elmallah RD, Bennett A, Mont MA. Liposomal Bupivacaine Suspension Can Reduce Lengths of Stay and Improve Discharge Status of Patients Undergoing Total Knee Arthroplasty. J Knee Surg. 2016 Jul;29(5):e3. doi: 10.1055/s-0036-1584272. Epub 2016 Jun 10. No abstract available.
• Background Emerson RH, Barrington JW, Olugbode O, Lovald S, Watson H, Ong K. Comparison of Local Infiltration Analgesia to Bupivacaine Wound Infiltration as Part of a Multimodal Pain Program in Total Hip Replacement. J Surg Orthop Adv. 2015 Winter;24(4):235-41.
• Background Emerson RH Jr, Barrington JW, Olugbode O, Lovald S, Watson H, Ong K. Femoral Nerve Block Versus Long-Acting Wound Infiltration in Total Knee Arthroplasty. Orthopedics. 2016 May 1;39(3):e449-55. doi: 10.3928/01477447-20160315-03. Epub 2016 Mar 29.
• Background Yu SW, Szulc AL, Walton SL, Davidovitch RI, Bosco JA, Iorio R. Liposomal Bupivacaine as an Adjunct to Postoperative Pain Control in Total Hip Arthroplasty. J Arthroplasty. 2016 Jul;31(7):1510-5. doi: 10.1016/j.arth.2016.01.004. Epub 2016 Jan 21.
• Background Kim KT, Cho DC, Sung JK, Kim YB, Kang H, Song KS, Choi GJ. Intraoperative systemic infusion of lidocaine reduces postoperative pain after lumbar surgery: a double-blinded, randomized, placebo-controlled clinical trial. Spine J. 2014 Aug 1;14(8):1559-66. doi: 10.1016/j.spinee.2013.09.031. Epub 2013 Nov 8.
• Background Puffer RC, Tou K, Winkel RE, Bydon M, Currier B, Freedman BA. Liposomal bupivacaine incisional injection in single-level lumbar spine surgery. Spine J. 2016 Nov;16(11):1305-1308. doi: 10.1016/j.spinee.2016.06.013. Epub 2016 Jun 24.
• Background Tomov M, Tou K, Winkel R, Puffer R, Bydon M, Nassr A, Huddleston P, Yaszemski M, Currier B, Freedman B. Does Subcutaneous Infiltration of Liposomal Bupivacaine Following Single-Level Transforaminal Lumbar Interbody Fusion Surgery Improve Immediate Postoperative Pain Control? Asian Spine J. 2018 Feb;12(1):85-93. doi: 10.4184/asj.2018.12.1.85. Epub 2018 Feb 7.
• Background Wang MY, Grossman J. Endoscopic minimally invasive transforaminal interbody fusion without general anesthesia: initial clinical experience with 1-year follow-up. Neurosurg Focus. 2016 Feb;40(2):E13. doi: 10.3171/2015.11.FOCUS15435.
• Background Kalso E, Edwards JE, Moore AR, McQuay HJ. Opioids in chronic non-cancer pain: systematic review of efficacy and safety. Pain. 2004 Dec;112(3):372-380. doi: 10.1016/j.pain.2004.09.019.
• Background Benyamin R, Trescot AM, Datta S, Buenaventura R, Adlaka R, Sehgal N, Glaser SE, Vallejo R. Opioid complications and side effects. Pain Physician. 2008 Mar;11(2 Suppl):S105-20.
• Background Oderda GM, Evans RS, Lloyd J, Lipman A, Chen C, Ashburn M, Burke J, Samore M. Cost of opioid-related adverse drug events in surgical patients. J Pain Symptom Manage. 2003 Mar;25(3):276-83. doi: 10.1016/s0885-3924(02)00691-7.
• Background Oderda GM, Gan TJ, Johnson BH, Robinson SB. Effect of opioid-related adverse events on outcomes in selected surgical patients. J Pain Palliat Care Pharmacother. 2013 Mar;27(1):62-70. doi: 10.3109/15360288.2012.751956. Epub 2013 Jan 9.
• Background Million R, Hall W, Nilsen KH, Baker RD, Jayson MI. Assessment of the progress of the back-pain patient 1981 Volvo Award in Clinical Science. Spine (Phila Pa 1976). 1982 May-Jun;7(3):204-12. doi: 10.1097/00007632-198205000-00004.
• Background Lehmann N, Joshi GP, Dirkmann D, Weiss M, Gulur P, Peters J, Eikermann M. Development and longitudinal validation of the overall benefit of analgesia score: a simple multi-dimensional quality assessment instrument. Br J Anaesth. 2010 Oct;105(4):511-8. doi: 10.1093/bja/aeq186. Epub 2010 Aug 6.

Drugs

Indications