Use of Exparel for Postoperative Analgesia Following Bariatric Surgery
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|ClinicalTrials.gov Identifier: NCT03975283|
Recruitment Status : Not yet recruiting
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Post Operative Pain||Drug: Exparel 266 MG Per 20 ML Injection Drug: Bupivacaine Hcl 0.25% Inj||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Use of Long-acting Local Analgesia in Bariatrics: A Randomized Controlled Trial|
|Estimated Study Start Date :||August 2019|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||August 2021|
Experimental: Exparel (Liposomal Bupivicaine)
20 ml vial of liposomal bupivacaine containing 266 mg (maximum dose), will be diluted with 20 ml of 0.25% bupivacaine (containing 50 mg of bupivacaine) and 20 ml saline (60 ml total). That total volume will be divided into two 30 ml syringes, and each will be used (per side) for the TAP blocks.
Drug: Exparel 266 MG Per 20 ML Injection
266mg of liposomal bupivacaine 266 mg, 20 mL volume, will be diluted with 20 ml of 0.25% bupivacaine (50 mg of bupivacaine) and 20 ml saline, thereby totalling 60mL volume. Total volume will be divided into two 30 ml syringes, and each will be used (per side) for the TAP blocks.
Active Comparator: 0.25% Bupivicaine HCL
Two 30 ml of 0.25% bupivacaine is drawn up and given on each side after identification of planes and levels via laparoscopy. Medication will be given just below the last rib and extend to below the lowest incision.
Drug: Bupivacaine Hcl 0.25% Inj
0.25% bupivacaine, 60mL total, divided into two 30mL syringes and delivered via TAP block on either side.
- Efficacy of liposomal bupivicaine via TAP block in eliminating narcotic use post-operatively [ Time Frame: 10 days ]Proportion of patients requiring narcotics post-procedure until discharge as recorded via their electronic medical record.
- Analog pain scores [ Time Frame: 10 days (or until discharge) ]Pain will be assessed in the post-anaesthesia care unit (PACU) at 2 occasions - upon arrival and before transfer to ward. Subsequently, pain scores will then be reassessed at 8 am, 2 pm, and 8pm until discharge. Pain will be measured on an 11-point scale from 0 (no pain) to 10 (most pain imaginable) and the average of the PACU and ward scores will be used as the final outcomes.
- Post-operative nausea [ Time Frame: 10 days (or until discharge) ]Postoperative nausea scores will be assessed daily at 8 am, 2 pm, and 8pm until discharge using an 11-point scale from 0 (no nausea) to 10 (most nausea imaginable)
- Post-operative Narcotic Use [ Time Frame: 10 days (or until discharge) ]Postoperative narcotic use will be recorded in morphine equivalent units and recorded via their electronic medical record.
- Hospital Length of Stay [ Time Frame: Total length of stay will be calculated from registration until discharge to home; usually spans 2-5 days. ]Length of stay calculated in hours
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03975283
|Contact: Karen Barlow||905-522-1155 ext email@example.com|
|Principal Investigator:||Margherita Cadeddu, MD, FRCSC||McMaster University|