Clinical trial NCT03975283: Use of Exparel for Postoperative Analgesia Following Bariatric Surgery
Official title: Use of Long-acting Local Analgesia in Bariatrics: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Post Operative Pain
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Pacira Pharmaceuticals, Inc
First posted: 2019-06-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the efficacy of liposomal bupivicaine in post operative analgesia for patients undergoing bariatric surgery when compared to conventional local analgesia. Patients will be randomly selected to receive either liposomal bupivicaine or conventional bupivicaine via a transversus abdominal plane block during surgery. Patients will be followed post-operatively to assess use of narcotics, post-operative pain and nausea scores, and length of stay.

Detailed description: Optimizing pain management following bariatric surgery is an important aspect of patient care and post-surgical recovery. Despite advances in post-operative pain management, this remains a challenge and opioids continue to dominate as the most widely used analgesia for post-surgical pain management. Opioid use especially in the opioid-naive patient carries significant short term and long term risks including over dependence and chronic opioid use.

Movements towards minimizing post-operative opioid use has shown regional anesthetic techniques to be highly effective in the management of pain in surgical patients. More specifically, liposomal bupivicaine (Exparel) is a novel non-opioid local analgesia that takes advantage of a multi-vesicular liposomal system to provide extended analgesia release over 72-96 hours.

The purpose of this study to evaluate the use of liposomal bupivicaine in the management of post-operative pain following bariatric surgery via a transversus abdominis plane (TAP) block. Patients will be randomized to receiving either liposomal bupivicaine or traditional 0.25% bupivicaine locally infiltrated at the time of bariatric surgery. Both liposomal bupivicaine and traditional bupivicaine will be administered via TAP block after identification of planes via laparoscopy by the bariatric surgeon.

Patients will be followed post-operatively to assess use of opioid analgesia between the two arms. In addition, they will be assessed with respect to pain and nausea using analog scores, as well as hospital length of stay.

Eligibility criteria: Inclusion Criteria:

* The patient previously met NIH criteria for bariatric surgery and has not received a previous bariatric surgical procedure
* The patient is aged 18-65 years and has completed the screening and preparation process prescribed by the Ontario Bariatric Network

Exclusion Criteria:

* Inability to give informed consent
* ASA \> 4
* Planned procedure other than Roux-en-Y gastric bypass (RYGB) or contraindications to RYGB
* BMI \> 55 kg/m2
* Revisional procedure
* Allergies or suspected allergies to local anesthetic medications (bupivicaine)
* Renal insufficiency (GFR \< 30ml/min)
* History of chronic pain needing daily medications for the last \>3 months

Primary outcomes:
measure: Efficacy of liposomal bupivicaine via TAP block in eliminating narcotic use post-operatively
timeFrame: 10 days
Secondary outcomes:
measure: Analog pain scores
timeFrame: 10 days (or until discharge)
measure: Post-operative nausea
timeFrame: 10 days (or until discharge)
measure: Post-operative Narcotic Use
timeFrame: 10 days (or until discharge)
measure: Hospital Length of Stay
timeFrame: Total length of stay will be calculated from registration until discharge to home; usually spans 2-5 days.
Other outcomes:
Locations:
Study officials:
affiliation: McMaster University
name: Margherita Cadeddu, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Boerboom SL, de Haes A, Vd Wetering L, Aarts EO, Janssen IMC, Geurts JW, Kamphuis ET. Preperitoneal Bupivacaine Infiltration Reduces Postoperative Opioid Consumption, Acute Pain, and Chronic Postsurgical Pain After Bariatric Surgery: a Randomized Controlled Trial. Obes Surg. 2018 Oct;28(10):3102-3110. doi: 10.1007/s11695-018-3341-6.
citation: Ilfeld BM, Viscusi ER, Hadzic A, Minkowitz HS, Morren MD, Lookabaugh J, Joshi GP. Safety and Side Effect Profile of Liposome Bupivacaine (Exparel) in Peripheral Nerve Blocks. Reg Anesth Pain Med. 2015 Sep-Oct;40(5):572-82. doi: 10.1097/AAP.0000000000000283.
citation: Surdam JW, Licini DJ, Baynes NT, Arce BR. The use of exparel (liposomal bupivacaine) to manage postoperative pain in unilateral total knee arthroplasty patients. J Arthroplasty. 2015 Feb;30(2):325-9. doi: 10.1016/j.arth.2014.09.004. Epub 2014 Sep 16.
citation: Bramlett K, Onel E, Viscusi ER, Jones K. A randomized, double-blind, dose-ranging study comparing wound infiltration of DepoFoam bupivacaine, an extended-release liposomal bupivacaine, to bupivacaine HCl for postsurgical analgesia in total knee arthroplasty. Knee. 2012 Oct;19(5):530-6. doi: 10.1016/j.knee.2011.12.004. Epub 2012 Jan 28.
citation: Ilfeld BM, Malhotra N, Furnish TJ, Donohue MC, Madison SJ. Liposomal bupivacaine as a single-injection peripheral nerve block: a dose-response study. Anesth Analg. 2013 Nov;117(5):1248-56. doi: 10.1213/ANE.0b013e31829cc6ae.