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TAP Block With Liposomal Bupivacaine Versus Pre-incisional Wound Infiltration With Bupivacaine for Postoperative Pain (LATAP)

Primary Purpose

Postoperative Pain

Status
Terminated
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Pre-incisional wound infiltration
Laparoscope to place TAP block with liposomal bupivacaine
Liposomal bupivacaine
Bupivacaine
Ketorolac
Sponsored by
University of Tennessee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain focused on measuring laparoscopic hysterectomy, robotic assisted hysterectomy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • ASA physical status 1-3,
  • Scheduled for laparoscopic or robotic assisted laparoscopic hysterectomy,
  • Able to participate personally or by legal representation in informed consent

Exclusion Criteria:

  • History of relevant allergy to the study drugs (Bupivacaine),
  • Chronic opioid use or drug abuse history,
  • Inability to understand the study protocol,
  • Refusal to provide written consent,
  • Soft tissue infection of the abdominal wall and skin

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Group A: pre-incisional bupivacaine

    Group B: laparoscope to place TAP block

    Arm Description

    Intervention: Pre-incisional wound infiltration with bupivacaine plain 0.25%. Ketorolac 30mg IV will be given following surgical procedure.

    Intervention: laparoscope to place TAP block with liposomal bupivacaine and bupivacaine plain 0.25%. Ketorolac 30 mg IV will be given following surgical procedure.

    Outcomes

    Primary Outcome Measures

    Visual Analog pain scores (VAS)
    Postoperative pain at 1 hour and 2 hours after arrival to recovery using Visual Analog Pain Scores (VAS) VAS: 0 (no pain) TO 10 (worst possible pain)

    Secondary Outcome Measures

    Narcotic pain medication usage
    Narcotic pain medication usage intraoperative and in recovery assessed as morphine equivalents
    Narcotic pain medication following surgery
    Narcotic pain medication pill counts up to one week postoperatively

    Full Information

    First Posted
    March 11, 2015
    Last Updated
    April 27, 2020
    Sponsor
    University of Tennessee
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02400645
    Brief Title
    TAP Block With Liposomal Bupivacaine Versus Pre-incisional Wound Infiltration With Bupivacaine for Postoperative Pain
    Acronym
    LATAP
    Official Title
    Comparison of Laparoscopically Assisted Transversus Abdominis Plane Block Using Liposomal Bupivacaine With Pre-incisional Bupivacaine for Post-operative Pain Control in Patients Undergoing Laparoscopic or Robotic Hysterectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Terminated
    Why Stopped
    It was determined that one member of the team had falsified data.
    Study Start Date
    March 2015 (undefined)
    Primary Completion Date
    May 2016 (Actual)
    Study Completion Date
    May 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Tennessee

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    In this randomized, controlled, double-blinded trial we plan to evaluate post-operative pain relief after laparoscopic-assisted Transversus Abdominis Plane (TAP) block using liposomal bupivacaine plus bupivacaine versus pre-incisional would infiltration with bupivacaine in patients undergoing Total laparoscopic or robotic assisted laparoscopic hysterectomy.
    Detailed Description
    Patients undergoing laparoscopic or robotic assisted total hysterectomy at Erlanger Hospital will be randomized into one of two groups to receive either laparoscopic assisted TAP block with liposomal bupivacaine and bupivacaine (Group A) or pre-incisional bupivacaine (Group B). The remaining aspects of the perioperative care, including the general anesthesia care and postoperative care will be similar for all patients. Ideally, patients will be informed and consented for the study in the preoperative clinic setting. They will be randomized in the pre-anesthesia care unit. Patients in Group A will receive laparoscopic-assisted bilateral TAP blocks using 10cc liposomal bupivacaine, 10cc Bupivacaine 0.25% and 10cc Normal Saline one each side. Patients in Group B will receive a total of 20cc pre-incisional Bupivacaine divided between each of the trocar sites. All patients will receive Ketorolac 30 mg, IV at the conclusion of surgery. All patients will be offered either oral pain medications or patient controlled anesthesia (PCA) opiate pain medication as indicated. Morphine equivalents will be calculated. Postoperative pain control will be assessed using Visual Analog Pain Score (VAS). This will be done by recovery room personnel who will be blinded as to whether the patients received TAP block or pre-incisional anesthetic. VAS will be assessed at rest at 1 hour and 2 hours after arrival to PACU. Patients will be assessed with Overall Benefit of Anesthesia Score (OBAS) questionnaires at postoperative days 1, 2 and 7. OBAS questionnaires will be done by personnel blinded to anesthesia technique. Patients will also be blinded as to which group they were in. Total morphine equivalents of intraoperative and postoperative pain medications will be calculated through postoperative day 7.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain
    Keywords
    laparoscopic hysterectomy, robotic assisted hysterectomy

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    69 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A: pre-incisional bupivacaine
    Arm Type
    Active Comparator
    Arm Description
    Intervention: Pre-incisional wound infiltration with bupivacaine plain 0.25%. Ketorolac 30mg IV will be given following surgical procedure.
    Arm Title
    Group B: laparoscope to place TAP block
    Arm Type
    Active Comparator
    Arm Description
    Intervention: laparoscope to place TAP block with liposomal bupivacaine and bupivacaine plain 0.25%. Ketorolac 30 mg IV will be given following surgical procedure.
    Intervention Type
    Procedure
    Intervention Name(s)
    Pre-incisional wound infiltration
    Intervention Description
    Intraoperative: Pre-incisional bupivacaine 0.25% up to 20 cc divided dose for trocar incisions
    Intervention Type
    Procedure
    Intervention Name(s)
    Laparoscope to place TAP block with liposomal bupivacaine
    Other Intervention Name(s)
    Laparoscopic TAP block with Liposomal bupivacaine
    Intervention Description
    Intraoperative: Laparoscopic TAP block with Liposomal bupivacaine and bupivacaine 0.25%
    Intervention Type
    Drug
    Intervention Name(s)
    Liposomal bupivacaine
    Other Intervention Name(s)
    Exparel
    Intervention Description
    Use of Liposomal bupivacaine in laparoscopic TAP block
    Intervention Type
    Drug
    Intervention Name(s)
    Bupivacaine
    Other Intervention Name(s)
    Marcaine
    Intervention Description
    20 cc Bupivacaine 0.25% plain will be used for either pre-incisional injection or added to laparoscopic TAP block solution.
    Intervention Type
    Drug
    Intervention Name(s)
    Ketorolac
    Other Intervention Name(s)
    Toradol
    Intervention Description
    Ketorolac 30mg to be given IV at end of surgical procedure unless contraindicated.
    Primary Outcome Measure Information:
    Title
    Visual Analog pain scores (VAS)
    Description
    Postoperative pain at 1 hour and 2 hours after arrival to recovery using Visual Analog Pain Scores (VAS) VAS: 0 (no pain) TO 10 (worst possible pain)
    Time Frame
    Two hours
    Secondary Outcome Measure Information:
    Title
    Narcotic pain medication usage
    Description
    Narcotic pain medication usage intraoperative and in recovery assessed as morphine equivalents
    Time Frame
    2 hours postoperative
    Title
    Narcotic pain medication following surgery
    Description
    Narcotic pain medication pill counts up to one week postoperatively
    Time Frame
    1 week
    Other Pre-specified Outcome Measures:
    Title
    Overall Benefit of Anesthesia scores (OBAS) on postoperative days 1,2 and 7
    Description
    Overall Benefit of Anesthesia Scores (OBAS) Questionnaires at postoperative days 1,2 and 7. OBAS covers pain, vomiting, itching, sweating, freezing, dizziness and overall satisfaction on a scale of 0 to 10.
    Time Frame
    One week

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: ASA physical status 1-3, Scheduled for laparoscopic or robotic assisted laparoscopic hysterectomy, Able to participate personally or by legal representation in informed consent Exclusion Criteria: History of relevant allergy to the study drugs (Bupivacaine), Chronic opioid use or drug abuse history, Inability to understand the study protocol, Refusal to provide written consent, Soft tissue infection of the abdominal wall and skin
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Shanti I Mohling, MD
    Organizational Affiliation
    University of Tennessee
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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