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Use of Exparel for Postoperative Analgesia Following Bariatric Surgery

Primary Purpose

Post Operative Pain

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Exparel 266 MG Per 20 ML Injection
Bupivacaine Hcl 0.25% Inj
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Exparel (Liposomal Bupivicaine)

    0.25% Bupivicaine HCL

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Efficacy of liposomal bupivicaine via TAP block in eliminating narcotic use post-operatively
    Proportion of patients requiring narcotics post-procedure until discharge as recorded via their electronic medical record.

    Secondary Outcome Measures

    Analog pain scores
    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
    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
    Postoperative narcotic use will be recorded in morphine equivalent units and recorded via their electronic medical record.
    Hospital Length of Stay
    Length of stay calculated in hours

    Full Information

    First Posted
    May 31, 2019
    Last Updated
    June 4, 2019
    Sponsor
    McMaster University
    Collaborators
    Pacira Pharmaceuticals, Inc
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03975283
    Brief Title
    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

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2019 (Anticipated)
    Primary Completion Date
    August 2021 (Anticipated)
    Study Completion Date
    August 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    McMaster University
    Collaborators
    Pacira Pharmaceuticals, Inc

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post Operative Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Exparel (Liposomal Bupivicaine)
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    0.25% Bupivicaine HCL
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Exparel 266 MG Per 20 ML Injection
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Bupivacaine Hcl 0.25% Inj
    Intervention Description
    0.25% bupivacaine, 60mL total, divided into two 30mL syringes and delivered via TAP block on either side.
    Primary Outcome Measure Information:
    Title
    Efficacy of liposomal bupivicaine via TAP block in eliminating narcotic use post-operatively
    Description
    Proportion of patients requiring narcotics post-procedure until discharge as recorded via their electronic medical record.
    Time Frame
    10 days
    Secondary Outcome Measure Information:
    Title
    Analog pain scores
    Description
    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.
    Time Frame
    10 days (or until discharge)
    Title
    Post-operative nausea
    Description
    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)
    Time Frame
    10 days (or until discharge)
    Title
    Post-operative Narcotic Use
    Description
    Postoperative narcotic use will be recorded in morphine equivalent units and recorded via their electronic medical record.
    Time Frame
    10 days (or until discharge)
    Title
    Hospital Length of Stay
    Description
    Length of stay calculated in hours
    Time Frame
    Total length of stay will be calculated from registration until discharge to home; usually spans 2-5 days.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Karen Barlow
    Phone
    905-522-1155
    Ext
    33739
    Email
    kbarlow@stjoes.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Margherita Cadeddu, MD, FRCSC
    Organizational Affiliation
    McMaster University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    No plan to share individual participant data
    Citations:
    PubMed Identifier
    24733580
    Citation
    Raebel MA, Newcomer SR, Bayliss EA, Boudreau D, DeBar L, Elliott TE, Ahmed AT, Pawloski PA, Fisher D, Toh S, Donahoo WT. Chronic opioid use emerging after bariatric surgery. Pharmacoepidemiol Drug Saf. 2014 Dec;23(12):1247-57. doi: 10.1002/pds.3625. Epub 2014 Apr 14.
    Results Reference
    background
    PubMed Identifier
    23049275
    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.
    Results Reference
    background
    PubMed Identifier
    22900785
    Citation
    Dasta J, Ramamoorthy S, Patou G, Sinatra R. Bupivacaine liposome injectable suspension compared with bupivacaine HCl for the reduction of opioid burden in the postsurgical setting. Curr Med Res Opin. 2012 Oct;28(10):1609-15. doi: 10.1185/03007995.2012.721760. Epub 2012 Sep 3.
    Results Reference
    background
    PubMed Identifier
    23204866
    Citation
    Cohen SM. Extended pain relief trial utilizing infiltration of Exparel((R)), a long-acting multivesicular liposome formulation of bupivacaine: a Phase IV health economic trial in adult patients undergoing open colectomy. J Pain Res. 2012;5:567-72. doi: 10.2147/JPR.S38621. Epub 2012 Nov 20.
    Results Reference
    background
    PubMed Identifier
    29061282
    Citation
    Bhakta A, Glotzer O, Ata A, Tafen M, Stain SC, Singh PT. Analgesic efficacy of laparoscopic-guided transverse abdominis plane block using liposomal bupivacaine in bariatric surgery. Am J Surg. 2018 Apr;215(4):643-646. doi: 10.1016/j.amjsurg.2017.09.006. Epub 2017 Sep 20.
    Results Reference
    background
    PubMed Identifier
    29926357
    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.
    Results Reference
    background
    PubMed Identifier
    26204387
    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.
    Results Reference
    background
    PubMed Identifier
    25282071
    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.
    Results Reference
    background
    PubMed Identifier
    22285545
    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.
    Results Reference
    background
    PubMed Identifier
    24108252
    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.
    Results Reference
    background

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    Use of Exparel for Postoperative Analgesia Following Bariatric Surgery

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