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Lack of enrollment
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| Name | Class |
|---|---|
| Twin Cities Spine Center | OTHER |
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This study will describe postoperative pain management for spine surgery patients receiving liposomal bupivacaine (Exparel®) compared to patients not receiving the drug.
This study will describe postoperative pain management for spine surgery patients receiving liposomal bupivacaine (Exparel®) compared to patients not receiving the drug. It is a prospective, randomized clinical trial with two cohorts: Group A: standard of care (SOC) plus liposomal bupivacaine (n=30) and Group B: SOC (n=30). All subjects will undergo open single-level posterior decompression and instrumented fusion for degenerative spondylolisthesis. The surgery is not an experimental procedure. Prior to closing the surgical wound, liposomal bupivacaine will be administered to Group A. The administration of the drug is a study procedure, but note that this is an indicated use of the drug. Postoperatively, subjects will be assessed for pain and opioid consumption. The investigator's hypothesis for statistical analysis is that there will be a 30% decrease in pain medication requirement for the experimental group (Group A: Liposomal bupivacaine ) versus the control group (Group B: No Liposomal bupivacaine).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Exparel | Experimental | Standard of Care plus Liposomal bupivacaine (Exparel®). Dosage: Exparel® 20 mL single use vial, 1.3% (13.3 mg/mL), Maximum dose of 266 mg (20 mL). Frequency: Single intraoperative administration |
|
| Group B: No Exparel | No Intervention | Standard of Care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal bupivacaine | Drug | 20ml bupivacaine liposome injectable suspension 1.3% (266mg) + 50ml 0.25% Bupivacaine (150mg) + 70ml preservative-free 0.9% neutral saline |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual Analog Pain Scores | Change in Visual Analog Pain Scores over time; respondents report pain at incision site and at drain site on a scale of No pain (0) to Intolerable pain (10). | Through study completion, an average of 2.5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Pain | Proportion of pain free subjects, an average of 2.5 days | Through study completion, an average of 2.5 days |
| Discomfort | Overall Benefit of Analgesia Score. Respondents complete seven questions, each with a score of 0 (minimal or not at all) to 4 (maximum or very much); the total OBAS ranges between 0 (complete relief of pain) and 28 (no benefit). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Alcala-Marquez, MD | Allina Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abbott Northwestern Hospital, Allina Health System | Minneapolis | Minnesota | 55407 | United States | ||
| United Hospital, Allina Health System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26790796 | 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. | |
| 12873949 | 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. |
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There is not a plan to make IPD available.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 19, 2018 | Nov 12, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| D007405 | Intervertebral Disc Displacement |
| C535531 | Intervertebral disc disease |
| D013168 | Spondylolisthesis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
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This is a prospective randomized clinical trial with two cohorts: one experimental and one control.
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Subjects will be blinded and will not be informed if they received the study drug or not.
|
| Through study completion, an average of 2.5 days |
| Total Opioid Consumption | Total postsurgical opioid consumption in morphine equivalents | Through study completion, an average of 2.5 days |
| Number of Opioid-related Adverse Events | Average number of opioid-related adverse events per patient | Through study completion, an average of 2.5 days |
| Patient Cost of In-Hospital Stay | Total combined cost in dollars of hospital room, drugs, laboratory tests, physical therapy, and respiratory therapy | Through study completion, an average of 2.5 days |
| Length of Stay | Number of days in the hospital | Through study completion, an average of 2.5 days |
| Saint Paul |
| Minnesota |
| 55102 |
| United States |
| 27108823 | 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. |
| 7599545 | 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. |
| 23049275 | 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. |
| 26410636 | 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. |
| 26680403 | 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. |
| 27285180 | 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. |
| 26731387 | 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. |
| 27018607 | 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. |
| 26872584 | 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. |
| 24216403 | 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. |
| 27349628 | 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. |
| 29503687 | 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. |
| 26828882 | 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. |
| 15561393 | 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. |
| 18443635 | 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. |
| 12614962 | 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. |
| 23302094 | 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. |
| 6214028 | 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. |
| 20693179 | 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. |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013169 | Spondylolysis |
| D055009 | Spondylosis |