Liposomal Bupivacaine in One-level Instrumented Posterior Spinal Fusion

Lumbar Spinal Stenosis Clinical Trial

Official title:

Does Liposomal Bupivacaine Improve Postoperative Pain Control After One Level Posterior Spinal Fusion With Instrumentation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03745040
• Other study ID #: 1252230
• Status: Recruiting
• Phase: Phase 4
• Start date: January 26, 2019
• Est. completion date: May 2024

Study information

• Verified date: March 2023
• Source: Allina Health System
• Contact: John M Dawson, PhD
• Phone: 612-775-6233
• Email: jmdawson[@]tcspine.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Has a primary diagnosis of single-level lumbar stenosis, disc herniation, and/or spondylolisthesis excluding degenerative disc disease

• Receives open, one-level posterior spinal fusion

Exclusion Criteria:

• Is opioid-tolerant. Opioid tolerant patients are receiving, for one week or longer, at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid.

• Experienced intraoperative complications (i.e., a dural tear or durotomy). Intra- and post-operative data will be excluded from the analysis for these patients.

• Has severe liver disease. Bupivacaine is primarily metabolized in the liver via conjugation with glucuronic acid. Patients with liver disease, especially severe disease may be more susceptible to toxicity.

• Has severe renal disease. Bupivacaine and the metabolite are primarily excreted by the kidneys. Excretion can be significantly changed by urinary perfusion, the presence of renal disease, factors affecting urinary pH, and renal blood flow

• Is less than 18 years old.

• Is pregnant.

• Cannot read and speak English.

Related Conditions & MeSH terms

• Intervertebral Disc Displacement
• Lumbar Disc Disease
• Lumbar Disc Herniation
• Lumbar Spinal Stenosis
• Lumbar Spondylolisthesis
• Spinal Stenosis
• Spondylolisthesis

Intervention

Drug:
• Liposomal bupivacaine
20ml bupivacaine liposome injectable suspension 1.3% (266mg) + 50ml 0.25% Bupivacaine (150mg) + 70ml preservative-free 0.9% neutral saline

Locations

Country	Name	City	State
United States	Abbott Northwestern Hospital, Allina Health System	Minneapolis	Minnesota
United States	United Hospital, Allina Health System	Saint Paul	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Allina Health System	Twin Cities Spine Center

Country where clinical trial is conducted

United States, 

References & Publications (21)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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).	Through study completion, an average of 2.5 days
Secondary	Total Opioid Consumption	Total postsurgical opioid consumption in morphine equivalents	Through study completion, an average of 2.5 days
Secondary	Number of Opioid-related Adverse Events	Average number of opioid-related adverse events per patient	Through study completion, an average of 2.5 days
Secondary	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
Secondary	Length of Stay	Number of days in the hospital	Through study completion, an average of 2.5 days