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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
Sponsor:
Collaborator:
Pacira Pharmaceuticals, Inc
Information provided by (Responsible Party):
McMaster University

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.

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

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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)

  3. 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.

  4. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Karen Barlow 905-522-1155 ext 33739 kbarlow@stjoes.ca

Sponsors and Collaborators
McMaster University
Pacira Pharmaceuticals, Inc
Investigators
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Principal Investigator: Margherita Cadeddu, MD, FRCSC McMaster University

Publications:

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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT03975283     History of Changes
Other Study ID Numbers: SJHC80
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share individual participant data

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents