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Postoperative Analgesia in Laparoscopic Abdominal Surgery After Exparel Via TAP or Local Infiltration

Primary Purpose

Pain, Postoperative, Anesthesia, Local, Anesthesia; Functional

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exparel 266 MG Per 20 ML Injection
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients scheduled for elective laparoscopic colorectal surgery at UWMC requiring inpatient stay

Exclusion Criteria:

  • Patients on chronic pain mediations equaling or exceeding > 25 morphine daily equivalents
  • Patients allergic to bupivacaine
  • Patients with ASA status IV, V, or VI
  • Patients unable to consent
  • Patients that are pregnant
  • Patients that are incarcerated
  • Patients receiving procedures in addition to laparoscopic colorectal procedure
  • Patients on systemic anticoagulation precluding them from regional blocks

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Local infiltration

    Transversus abdominis plane block

    Arm Description

    Liposomal bupivacaine (266mg) will be directly infiltrated by the surgeon into the surgical laparoscopic wound sites.

    Liposomal bupivacaine (266mg) will be used in a ultrasound guided transversus abdominis plane block.

    Outcomes

    Primary Outcome Measures

    24 hour post operative opioid consumption
    Listed in morphine daily equivalents.

    Secondary Outcome Measures

    12 hour post operative opioid consumption
    Listed in morphine daily equivalents
    48 hour post operative opioid consumption
    Listed in morphine daily equivalents
    Pain intensity at 12 hours post operative
    Self reported pain intensity by visual analog scale scored 0-10 (0 = no pain; 10 = worst pain imaginable)
    Pain intensity at 24 hours post operative
    Self reported pain intensity by visual analog scale scored 0-10 (0 = no pain; 10 = worst pain imaginable)
    Hospital length of stay
    How long the patient requires their inpatient stay measured in days.

    Full Information

    First Posted
    April 18, 2019
    Last Updated
    April 23, 2019
    Sponsor
    University of Washington
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03927326
    Brief Title
    Postoperative Analgesia in Laparoscopic Abdominal Surgery After Exparel Via TAP or Local Infiltration
    Official Title
    On Postoperative Analgesic Requirements in Laparoscopic Colorectal Surgery Patients After Exparel Administration Via Transversus Abdominis Plane Block Versus Surgical Infiltration
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2019 (Anticipated)
    Primary Completion Date
    July 2020 (Anticipated)
    Study Completion Date
    July 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Washington

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study evaluates differences in how administering liposomal bupivacaine via two different methods affects postoperative pain control in laparoscopic abdominal surgery patients. Half the participants will receive liposomal bupivacaine via a transverses abdominis plane block while the other half will receive liposomal bupivacaine via local infiltration.
    Detailed Description
    Liposomal bupivacaine is a newer formulation of a local anesthetic that is commonly used for local infiltration, peripheral nerve blocks, and neuraxial anesthesia. This new formulation allows the effects of bupivacaine to last up to 72 hours as it is slowly released from a liposome. It is FDA approved for local infiltration and has recently been approved for interscalene blocks. A transversus abdominis plane block is a fascial plane block that is performed routinely for postoperative pain relief for some abdominal incisions. It is performed by placing local anesthetic between the internal oblique and transverses abdominis muscle planes where it will provide analgesia to several dermatomes of the abdomen in hopes of improving postoperative pain relief and reducing postoperative opioid requirement.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Postoperative, Anesthesia, Local, Anesthesia; Functional, Anesthesia, Opioid Use

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Unblinded randomized trial
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Local infiltration
    Arm Type
    Experimental
    Arm Description
    Liposomal bupivacaine (266mg) will be directly infiltrated by the surgeon into the surgical laparoscopic wound sites.
    Arm Title
    Transversus abdominis plane block
    Arm Type
    Experimental
    Arm Description
    Liposomal bupivacaine (266mg) will be used in a ultrasound guided transversus abdominis plane block.
    Intervention Type
    Drug
    Intervention Name(s)
    Exparel 266 MG Per 20 ML Injection
    Intervention Description
    Liposomal bupivacaine
    Primary Outcome Measure Information:
    Title
    24 hour post operative opioid consumption
    Description
    Listed in morphine daily equivalents.
    Time Frame
    24 hours postoperative
    Secondary Outcome Measure Information:
    Title
    12 hour post operative opioid consumption
    Description
    Listed in morphine daily equivalents
    Time Frame
    12 hours postoperative
    Title
    48 hour post operative opioid consumption
    Description
    Listed in morphine daily equivalents
    Time Frame
    48 hours postoperative
    Title
    Pain intensity at 12 hours post operative
    Description
    Self reported pain intensity by visual analog scale scored 0-10 (0 = no pain; 10 = worst pain imaginable)
    Time Frame
    12 hours
    Title
    Pain intensity at 24 hours post operative
    Description
    Self reported pain intensity by visual analog scale scored 0-10 (0 = no pain; 10 = worst pain imaginable)
    Time Frame
    24 hours
    Title
    Hospital length of stay
    Description
    How long the patient requires their inpatient stay measured in days.
    Time Frame
    Until end of hospital stay, typically 3 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients scheduled for elective laparoscopic colorectal surgery at UWMC requiring inpatient stay Exclusion Criteria: Patients on chronic pain mediations equaling or exceeding > 25 morphine daily equivalents Patients allergic to bupivacaine Patients with ASA status IV, V, or VI Patients unable to consent Patients that are pregnant Patients that are incarcerated Patients receiving procedures in addition to laparoscopic colorectal procedure Patients on systemic anticoagulation precluding them from regional blocks
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alan Chang, MD
    Phone
    714-878-0850
    Email
    achang5@uw.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Vanessa Loland, MD
    Organizational Affiliation
    University of Washington
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    We are not planning on making IPD available to other researchers.
    Citations:
    PubMed Identifier
    22570563
    Citation
    Bergese SD, Ramamoorthy S, Patou G, Bramlett K, Gorfine SR, Candiotti KA. Efficacy profile of liposome bupivacaine, a novel formulation of bupivacaine for postsurgical analgesia. J Pain Res. 2012;5:107-16. doi: 10.2147/JPR.S30861. Epub 2012 May 1.
    Results Reference
    background
    PubMed Identifier
    22067185
    Citation
    Gorfine SR, Onel E, Patou G, Krivokapic ZV. Bupivacaine extended-release liposome injection for prolonged postsurgical analgesia in patients undergoing hemorrhoidectomy: a multicenter, randomized, double-blind, placebo-controlled trial. Dis Colon Rectum. 2011 Dec;54(12):1552-9. doi: 10.1097/DCR.0b013e318232d4c1.
    Results Reference
    background
    PubMed Identifier
    28786304
    Citation
    Mulligan RP, Morash JG, DeOrio JK, Parekh SG. Liposomal Bupivacaine Versus Continuous Popliteal Sciatic Nerve Block in Total Ankle Arthroplasty. Foot Ankle Int. 2017 Nov;38(11):1222-1228. doi: 10.1177/1071100717722366. Epub 2017 Aug 8.
    Results Reference
    background
    PubMed Identifier
    25540595
    Citation
    Sternlicht A, Shapiro M, Robelen G, Vellayappan U, Tuerk IA. Infiltration of liposome bupivacaine into the transversus abdominis plane for postsurgical analgesia in robotic laparoscopic prostatectomy: a pilot study. Local Reg Anesth. 2014 Dec 12;7:69-74. doi: 10.2147/LRA.S64515. eCollection 2014.
    Results Reference
    background
    PubMed Identifier
    26673040
    Citation
    Hadzic A, Abikhaled JA, Harmon WJ. Impact of volume expansion on the efficacy and pharmacokinetics of liposome bupivacaine. Local Reg Anesth. 2015 Dec 7;8:105-11. doi: 10.2147/LRA.S88685. eCollection 2015.
    Results Reference
    background
    PubMed Identifier
    25031661
    Citation
    Candiotti KA, Sands LR, Lee E, Bergese SD, Harzman AE, Marcet J, Kumar AS, Haas E. Liposome Bupivacaine for Postsurgical Analgesia in Adult Patients Undergoing Laparoscopic Colectomy: Results from Prospective Phase IV Sequential Cohort Studies Assessing Health Economic Outcomes. Curr Ther Res Clin Exp. 2013 Dec 27;76:1-6. doi: 10.1016/j.curtheres.2013.12.001. eCollection 2014 Dec.
    Results Reference
    background
    PubMed Identifier
    24612211
    Citation
    Gastevski D. Infiltration of liposome bupivacaine into the transversus abdominis plane for postsurgical pain management in a 39-year-old female undergoing laparoscopic cholecystectomy. Pain Med. 2014 Aug;15(8):1312-5. doi: 10.1111/pme.12356. Epub 2014 Jan 21.
    Results Reference
    background

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    Postoperative Analgesia in Laparoscopic Abdominal Surgery After Exparel Via TAP or Local Infiltration

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