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Transversus Abdominal Plane Block at Total Laparoscopic Hysterectomy: Effect on Quality of Recovery (TAP)

Primary Purpose

Pain, Postoperative, Anesthesia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TAP Block
Sponsored by
MetroHealth Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Postoperative focused on measuring recovery, postoperative, pain, laparoscopy, hysterectomy, ropivacaine, TAP block, local anesthesia

Eligibility Criteria

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

Inclusion Criteria:

  • Any patient undergoing laparoscopic hysterectomy
  • Age ranges 18-80
  • Reading literacy
  • English speaking
  • Able to give informed consent

Exclusion Criteria:

  • History of relevant drug allergy
  • Chronic opioid users who may have tolerance to pain medications
  • Inability to understand written consent forms or give consent
  • Age less than 18 or over 80
  • Any conversion to open surgery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    TAP Block

    No Block

    Arm Description

    20mL of 0.25% Ropivacaine with Epinephrine 1:200,000 is injected into bilateral transversus abdominal planes under ultrasound guidance.

    Patients randomized to this arm have band aids applied to sites on lateral abdomen without injection.

    Outcomes

    Primary Outcome Measures

    Quality of Recovery Questionnaire (QoR-40) on Postop Day #1 or #2
    40 question survey completed on paper or by telephone on post-operative day #1 or #2, designed to measure health status after surgery and anesthesia. Scale ranges from 40 (extremely poor qualify of recovery) to 200 (excellent quality of recovery).

    Secondary Outcome Measures

    Narcotic Use
    narcotic use in mg of Morphine will be recorded
    Visual Analog Scale (VAS) for Pain
    visual analogue scales for pain will be completed on post-operative day #0 and #1, pain is assessed on a 10-point visual analogue scale (0 = no pain; 1 to 3 = mild; 4 to 6 = moderate pain; 7 to 10 = severe pain.)
    Intraoperative Time
    The total time in the operating room will be recorded to see if there is a difference between groups.

    Full Information

    First Posted
    November 22, 2011
    Last Updated
    October 5, 2018
    Sponsor
    MetroHealth Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01479270
    Brief Title
    Transversus Abdominal Plane Block at Total Laparoscopic Hysterectomy: Effect on Quality of Recovery
    Acronym
    TAP
    Official Title
    Randomized Trial of Transversus Abdominal Plane (TAP) Block at Total Laparoscopic Hysterectomy: Effect of Regional Analgesia on Quality of Recovery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2011 (undefined)
    Primary Completion Date
    September 2011 (Actual)
    Study Completion Date
    January 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    MetroHealth Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The Transversus Abdominal Plane (TAP) block has been used with good success to decrease postoperative pain following laparatomy. If the TAP block provides any improvement in the quality of recovery following laparoscopic hysterectomy, it could decrease the need for postoperative narcotics and allow for more outpatient hysterectomy procedures.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Postoperative, Anesthesia
    Keywords
    recovery, postoperative, pain, laparoscopy, hysterectomy, ropivacaine, TAP block, local anesthesia

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    56 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    TAP Block
    Arm Type
    Active Comparator
    Arm Description
    20mL of 0.25% Ropivacaine with Epinephrine 1:200,000 is injected into bilateral transversus abdominal planes under ultrasound guidance.
    Arm Title
    No Block
    Arm Type
    No Intervention
    Arm Description
    Patients randomized to this arm have band aids applied to sites on lateral abdomen without injection.
    Intervention Type
    Drug
    Intervention Name(s)
    TAP Block
    Other Intervention Name(s)
    Ropivacaine with Epinephrine
    Intervention Description
    Bilateral transversus abdominal plane injection under ultrasound guidance, done at conclusion of hysterectomy procedure, prior to emergence from general anesthesia
    Primary Outcome Measure Information:
    Title
    Quality of Recovery Questionnaire (QoR-40) on Postop Day #1 or #2
    Description
    40 question survey completed on paper or by telephone on post-operative day #1 or #2, designed to measure health status after surgery and anesthesia. Scale ranges from 40 (extremely poor qualify of recovery) to 200 (excellent quality of recovery).
    Time Frame
    Postop Day #1 or Day #2
    Secondary Outcome Measure Information:
    Title
    Narcotic Use
    Description
    narcotic use in mg of Morphine will be recorded
    Time Frame
    Postop Day #0 and Day #1
    Title
    Visual Analog Scale (VAS) for Pain
    Description
    visual analogue scales for pain will be completed on post-operative day #0 and #1, pain is assessed on a 10-point visual analogue scale (0 = no pain; 1 to 3 = mild; 4 to 6 = moderate pain; 7 to 10 = severe pain.)
    Time Frame
    2 and 24 hours post operative
    Title
    Intraoperative Time
    Description
    The total time in the operating room will be recorded to see if there is a difference between groups.
    Time Frame
    the total intraoperative time in minutes

    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: Any patient undergoing laparoscopic hysterectomy Age ranges 18-80 Reading literacy English speaking Able to give informed consent Exclusion Criteria: History of relevant drug allergy Chronic opioid users who may have tolerance to pain medications Inability to understand written consent forms or give consent Age less than 18 or over 80 Any conversion to open surgery
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sarah M Kane, MD
    Organizational Affiliation
    MetroHealth Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22840413
    Citation
    Kane SM, Garcia-Tomas V, Alejandro-Rodriguez M, Astley B, Pollard RR. Randomized trial of transversus abdominis plane block at total laparoscopic hysterectomy: effect of regional analgesia on quality of recovery. Am J Obstet Gynecol. 2012 Nov;207(5):419.e1-5. doi: 10.1016/j.ajog.2012.06.052. Epub 2012 Jun 29.
    Results Reference
    derived

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    Transversus Abdominal Plane Block at Total Laparoscopic Hysterectomy: Effect on Quality of Recovery

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