search
Back to results

Subcostal TAP Block With Liposomal Bupivacaine Versus Bupivacaine in Donor Nephrectomy Patients: A Prospective Study

Primary Purpose

Acute Pain

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
liposomal bupivacaine
bupivacaine
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain

Eligibility Criteria

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

Inclusion Criteria:

  • presenting for donor nephrectomy

Exclusion Criteria:

  • non english speaking
  • chronic pain condition
  • taking chronic opioids

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    liposomal bupivacaine TAP

    bupivacaine TAP

    Arm Description

    Patients will receive a TAP block with liposomal bupivacaine

    Patients will receive a TAP block with bupivacaine

    Outcomes

    Primary Outcome Measures

    Numerical Rating Scale
    This was a measure of patient's reported pain on a 0-10 verbal numerical rating scale. 10 being worst pain. The maximal value for the time period 48-72 hours was chosen as the maximal pain during that time period.

    Secondary Outcome Measures

    Post Operative Opioid Use
    Number of Patients With Post Operative Nausea/Vomiting
    Post Operative Length of Stay
    Postoperative Opioid Use
    Use of opioids during 24-48 hours after surgery
    Post Operative Opioid Use
    Post operative opioid use from 0-24 hours after surgery.

    Full Information

    First Posted
    October 30, 2014
    Last Updated
    April 6, 2023
    Sponsor
    University of Minnesota
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02287623
    Brief Title
    Subcostal TAP Block With Liposomal Bupivacaine Versus Bupivacaine in Donor Nephrectomy Patients: A Prospective Study
    Official Title
    Subcostal TAP Block With Liposomal Bupivacaine vs Bupivacaine in Donor Nephrectomy Patients: A Prospective Randomized Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2013 (undefined)
    Primary Completion Date
    July 2014 (Actual)
    Study Completion Date
    October 2014 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The primary objective of this study is whether one local anesthetic, liposomal bupivacaine, provides improved pain control and decreased opioid use compared to bupivacaine when injected during a transversus abdominis plane block for donor nephrectomy patients.
    Detailed Description
    The primary objective of this study is whether one local anesthetic, liposomal bupivacaine, provides improved pain control and decreased opioid use compared to bupivacaine when injected during a transversus abdominis plane block for donor nephrectomy patients. Background and treatment procedure: Liposomal bupivacaine is a multi vesicular formulation of bupivacaine that has been shown to provide up to 72 hours of analgesia compared to bupivacaine which provides up to 24 hours of analgesia post injection. These two medications have been compared using a infiltration or injection at the site of incision but have yet to be compared when used during a TAP block. A TAP block is an injection of local anesthetic under the covering of the transversus abdominis muscle layer. This layer is found using an ultrasound which is a beam of high frequency sound that allows one to visualize images in the body. Then using this ultrasound we can see our needle as it pierces the covering of the transversus abdominis muscle layer and watch as the local anesthetic is injected into this plane. This is done on both sides of the abdomen to provide analgesia to the skin, muscle, and fascial layers of the abdomen. Population: Adult patients who are undergoing a donor nephrectomy Rationale: It will be useful to determine if one formulation or the other provides better and longer lasting pain control for patients undergoing abdominal procedures.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    liposomal bupivacaine TAP
    Arm Type
    Experimental
    Arm Description
    Patients will receive a TAP block with liposomal bupivacaine
    Arm Title
    bupivacaine TAP
    Arm Type
    Active Comparator
    Arm Description
    Patients will receive a TAP block with bupivacaine
    Intervention Type
    Drug
    Intervention Name(s)
    liposomal bupivacaine
    Intervention Description
    patients will receive a tap with liposomal bupivacaine
    Intervention Type
    Drug
    Intervention Name(s)
    bupivacaine
    Intervention Description
    patients will receive a tap with bupivacaine
    Primary Outcome Measure Information:
    Title
    Numerical Rating Scale
    Description
    This was a measure of patient's reported pain on a 0-10 verbal numerical rating scale. 10 being worst pain. The maximal value for the time period 48-72 hours was chosen as the maximal pain during that time period.
    Time Frame
    48-72 hours after injection
    Secondary Outcome Measure Information:
    Title
    Post Operative Opioid Use
    Time Frame
    48-72 hours
    Title
    Number of Patients With Post Operative Nausea/Vomiting
    Time Frame
    0-72 hours
    Title
    Post Operative Length of Stay
    Time Frame
    up to 30 days after surgery
    Title
    Postoperative Opioid Use
    Description
    Use of opioids during 24-48 hours after surgery
    Time Frame
    24-48 hours
    Title
    Post Operative Opioid Use
    Description
    Post operative opioid use from 0-24 hours after surgery.
    Time Frame
    0-24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: presenting for donor nephrectomy Exclusion Criteria: non english speaking chronic pain condition taking chronic opioids

    12. IPD Sharing Statement

    Learn more about this trial

    Subcostal TAP Block With Liposomal Bupivacaine Versus Bupivacaine in Donor Nephrectomy Patients: A Prospective Study

    We'll reach out to this number within 24 hrs