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TAP Block With Liposomal Bupivacaine Versus Bupivacaine in Robotic Hysterectomy

Primary Purpose

Acute Pain

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Bupivacaine
liposomal 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:

  • those who present for elective robotic assisted hysterectomy

Exclusion Criteria:

  • non english speaking
  • chronic pain
  • on opioids greater than 1 weeks
  • chronic anticoagulation
  • allergy to local anesthetics
  • use of spinal or epidural for surgery
  • lack of patient cooperation
  • contraindication to regional anesthesia

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    liposomal bupivacaine TAP

    bupivacaine TAP

    Arm Description

    these patients receive a subcostal TAP with liposomal bupivacaine

    These patients receive a subcostal TAP with bupivacaine

    Outcomes

    Primary Outcome Measures

    Post Operative Opioid Use
    To determine if liposomal bupivacaine provides decreased narcotic use when compared to bupivacaine when injected in a TAP block

    Secondary 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.
    Post Operative Length of Stay
    To determine if liposomal bupivacaine provides decreased length of stay when compared to bupivacaine when injected in a TAP block
    Patient Satisfaction as Assessed Via Patient Survey
    To determine if liposomal bupivacaine improves quality of recovery post-operatively when compared to bupivacaine when injected in a TAP block via a patient survey either in person or via telephone.

    Full Information

    First Posted
    October 30, 2014
    Last Updated
    May 8, 2023
    Sponsor
    University of Minnesota
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02289079
    Brief Title
    TAP Block With Liposomal Bupivacaine Versus Bupivacaine in Robotic Hysterectomy
    Official Title
    Ultrasound Guided Subcostal Transversus Abdominis Plane (TAP) Block With Liposomal Bupivacaine vs Bupivacaine in Robotic Hysterectomy Patients: A Prospective Randomized Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2013 (undefined)
    Primary Completion Date
    October 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 purpose of the study is to compare pain control after robotic hysterectomy surgery using either liposomal bupivacaine or Bupivacaine when injected during a transversus abdominis plane (TAP) block. Robotic hysterectomy is when a patient is electively having robotic assisted removal of one's uterus. Both medications liposomal bupivacaine and Bupivacaine are standard of care in these types of surgeries.
    Detailed Description
    Treatment technique: The patient will be in the supine position. The transversus abdominis muscle layer will be identified with the ultrasound. Using sterile technique, skin infiltration with 2% lidocaine will occur, 2 cm medial to the ultrasound probe. An 22g Nerve block needle will then be inserted and advanced under ultrasound guidance until it is below the fascial covering of the transversus abdominis muscle layer. Gentle aspiration for air, or blood will be performed and either 30 cc of 0.25% bupivacaine with 1/200,000 parts epinephrine or 30 mL of liposomal bupivacaine mixed 1:1 with normal saline will be injected under ultrasound guidance. For each 5cc of local anesthetic injected, aspiration will be performed. Upon completion of the injection, the needle will then be removed. This will then be completed on the contralateral side. The patient will be monitored in the preoperative area until he/she is brought into the operating room for their procedure. When the operation is complete the patient will either be discharged home or brought to the ward where each day a member of the research team will evaluate the patient for signs of complications and ask the patient their minimum and maximum pain score. If patients have met criterion for discharge to home including pain <4/10, independence of intravenous analgesia, and are stable for discharge medically, but are awaiting placement, the time of discharge for the purposes of the study will be the day they have met such criterion as opposed to the day of actual discharge, as this can vary depending on patient placement. If the patient is discharged prior to 72 hours post injection, then the patient will receive one phone call at 24 hours post injection, 48 hours post injection , and 72 hours post injection +/- 5 hours. During this phone call the patient will be asked about pain score, narcotic use, overall satisfaction via a recorded patient questionnaire, quality of recovery via a quality of recovery survey, and assessed if any adverse events have occurred. Adequate analgesia will be defined as <3 VAS at rest, and if VAS is greater than 3 adjustments in oral or intravenous pain medications will be given as determined by the nurse.

    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
    these patients receive a subcostal TAP with liposomal bupivacaine
    Arm Title
    bupivacaine TAP
    Arm Type
    Active Comparator
    Arm Description
    These patients receive a subcostal TAP with bupivacaine
    Intervention Type
    Drug
    Intervention Name(s)
    Bupivacaine
    Intervention Type
    Drug
    Intervention Name(s)
    liposomal bupivacaine
    Primary Outcome Measure Information:
    Title
    Post Operative Opioid Use
    Description
    To determine if liposomal bupivacaine provides decreased narcotic use when compared to bupivacaine when injected in a TAP block
    Time Frame
    0-72 hours after injection
    Secondary 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
    Title
    Post Operative Length of Stay
    Description
    To determine if liposomal bupivacaine provides decreased length of stay when compared to bupivacaine when injected in a TAP block
    Time Frame
    up to 30 days after surgery
    Title
    Patient Satisfaction as Assessed Via Patient Survey
    Description
    To determine if liposomal bupivacaine improves quality of recovery post-operatively when compared to bupivacaine when injected in a TAP block via a patient survey either in person or via telephone.
    Time Frame
    assessed at 72 hours after injection

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: those who present for elective robotic assisted hysterectomy Exclusion Criteria: non english speaking chronic pain on opioids greater than 1 weeks chronic anticoagulation allergy to local anesthetics use of spinal or epidural for surgery lack of patient cooperation contraindication to regional anesthesia

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26056753
    Citation
    Hutchins J, Delaney D, Vogel RI, Ghebre RG, Downs LS Jr, Carson L, Mullany S, Teoh D, Geller MA. Ultrasound guided subcostal transversus abdominis plane (TAP) infiltration with liposomal bupivacaine for patients undergoing robotic assisted hysterectomy: A prospective randomized controlled study. Gynecol Oncol. 2015 Sep;138(3):609-13. doi: 10.1016/j.ygyno.2015.06.008. Epub 2015 Jun 6.
    Results Reference
    derived

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    TAP Block With Liposomal Bupivacaine Versus Bupivacaine in Robotic Hysterectomy

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