search
Back to results

TAP Block for Postoperative Pain Control

Primary Purpose

Pain, Postoperative

Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Bupivacaine
Exparel®
Ropivacaine
Sponsored by
Joshua Herskovic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring transversus abdominis plane, postoperative, pain

Eligibility Criteria

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

Inclusion Criteria:

  • Ability to give written informed consent
  • Scheduled for open abdominal surgery
  • American Society of Anesthesiologists physical status 1 to 3

Exclusion Criteria:

  • Inability to understand the study or provide written informed consent
  • Inability to follow protocol instructions
  • Complicated history of chronic opioid use including daily use of opioids for a period greater than 2 weeks prior to surgery
  • Allergy to local anesthetic agents
  • Contraindication to regional nerve block such as:
  • Bleeding disorder
  • Sepsis
  • Infection at site of block
  • Body Mass Index (BMI) >40
  • Pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Single Injection of Bupivacaine

    Single Injection of Exparel®

    Continuous infusion of Ropivacaine

    Arm Description

    Subjects will undergo post-operative pain relief treatment with a single injection of Bupivacaine, a local anesthetic injected into the transversus abdominis plane.

    Subjects will undergo post-operative pain relief treatment with a single injection of Exparel®, a liposomal form of bupivacaine, into the transversus abdominis plane

    Subjects will be treated with a continuous infusion of the local anesthetic Ropivacaine with the ON-Q® pump

    Outcomes

    Primary Outcome Measures

    Total Dosage of Narcotic
    The total use of analgesic medications will be recorded during the 3 days immediately following surgery.

    Secondary Outcome Measures

    Postoperative Vomiting (Events)
    Total number of vomiting episodes over the three postoperative days.
    Patient Reported Pain by VAS Scale
    Patients will rate their pain by VAS scale 1 day post surgery. Scale is a 0 to 10 visual analog scale with 0 representing no pain and 10 representing severe pain.
    Patient Reported Pain by VAS Scale
    Patients will rate their pain by VAS scale 2 days post surgery. Scale is a 0 to 10 visual analog scale with 0 representing no pain and 10 representing severe pain.
    Patient Reported Pain by VAS Scale
    Patients will rate their pain by VAS scale 3 days post surgery. Scale is a 0 to 10 visual analog scale with 0 representing no pain and 10 representing severe pain.
    Number of Days Required for a Patient to Get Out of Bed
    Patients will be assessed each day following the day of surgery for the ability to get out of bed.
    Number of Days Required for a Patient to Walk Unassisted
    Patients will be assessed each day following the day of surgery for the ability to walk unassisted

    Full Information

    First Posted
    November 19, 2015
    Last Updated
    October 30, 2018
    Sponsor
    Joshua Herskovic
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02652156
    Brief Title
    TAP Block for Postoperative Pain Control
    Official Title
    Transversus Abdominis Plane (TAP) Block Study for Postoperative Pain Control
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Terminated
    Why Stopped
    Operational barriers at the site.
    Study Start Date
    November 1, 2015 (Actual)
    Primary Completion Date
    April 16, 2016 (Actual)
    Study Completion Date
    April 16, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Joshua Herskovic

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This clinical trial will examine differences in the effectiveness between three (3) commonly used methods and/or medications used to perform a transversus abdominis plane (TAP) block for post-operative pain control. The transversus abdominis muscle is either side between the lowest rib and the hip bone. Group A subjects will undergo post-operative pain relief treatment with a single injection of Bupivacaine injected into the TAP. Group B subjects will undergo post-operative pain relief treatment with a single injection of Exparel®, a liposomal form of bupivacaine into the TAP. Group C subjects will be treated with a continuous infusion of the local anesthetic ropivacaine with the ON-Q® pump. There will be no placebo group in this study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Postoperative
    Keywords
    transversus abdominis plane, postoperative, pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    14 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Single Injection of Bupivacaine
    Arm Type
    Active Comparator
    Arm Description
    Subjects will undergo post-operative pain relief treatment with a single injection of Bupivacaine, a local anesthetic injected into the transversus abdominis plane.
    Arm Title
    Single Injection of Exparel®
    Arm Type
    Active Comparator
    Arm Description
    Subjects will undergo post-operative pain relief treatment with a single injection of Exparel®, a liposomal form of bupivacaine, into the transversus abdominis plane
    Arm Title
    Continuous infusion of Ropivacaine
    Arm Type
    Active Comparator
    Arm Description
    Subjects will be treated with a continuous infusion of the local anesthetic Ropivacaine with the ON-Q® pump
    Intervention Type
    Drug
    Intervention Name(s)
    Bupivacaine
    Other Intervention Name(s)
    Marcaine, Sensorcaine
    Intervention Description
    60 ml Bupivacaine 0.25% will be drawn via 60 ml Syringe. The syringe will be connected and a 10ml flush syringe containing 10ml 0.9% Normal Saline (NS) will be connected to the end of an IV extension set via a 3-way stopcock and Luer lock connections. The Bupivacaine 0.25% syringe will be connected to the stopcock. The distal end of the IV connection will be connected to the injection needle. The entire setup will be flushed with 0.9% NS via flush syringe. The TAP space will also be located under ultrasound guidance and verified by using the 0.9% NS flush syringe. Once in the TAP space, 30 ml Bupivacaine 0.25% will be injected into the TAP space. This dose will be decreased to 25 ml for patients under 70 kg. The process will be repeated on the opposite side TAP block.
    Intervention Type
    Drug
    Intervention Name(s)
    Exparel®
    Other Intervention Name(s)
    bupivacaine liposome injectable suspension
    Intervention Description
    20 ml Exparel (266 mg) will be drawn into a 20 ml syringe. A 20 ml Bupivacaine 0.25% syringe and the syringe containing the Exparel solution will be connected to the end of an IV extension set via a 3-way stopcock. The IV connection will be connected to the injection needle. The setup will be flushed with the Bupivacaine syringe. The TAP space will be located under ultrasound guidance. 133mg of Exparel will be injected into the TAP space. After injection, the syringe will be exchanged for the Bupivacaine syringe and 20ml Bupivacaine injected into the space. The process will be repeated on the opposite side TAP block.
    Intervention Type
    Drug
    Intervention Name(s)
    Ropivacaine
    Other Intervention Name(s)
    Naropin
    Intervention Description
    40 ml Bupivacaine 0.25% will be drawn via two 20ml Syringes. A Bupivacaine 20ml syringe will be connected to an IV extension via a 3-way stopcock and Luer lock. The IV will be connected to an injection tuohy needle and flushed with NS. The TAP space will be located using ultrasound guidance. 15 ml Bupivacaine 0.25% will be injected. A catheter will be threaded through the tuohy needle into the TAP space. 5ml Bupivacaine 0.25% will then be injected. The catheter will be secured via standard technique. The process will be repeated for the opposite side. Patients will receive a filled ON-Q system. The ON-Q system contains Ropivacaine 0.2%. The pump will run at 7 ml/hr. per side.
    Primary Outcome Measure Information:
    Title
    Total Dosage of Narcotic
    Description
    The total use of analgesic medications will be recorded during the 3 days immediately following surgery.
    Time Frame
    3 postoperative days
    Secondary Outcome Measure Information:
    Title
    Postoperative Vomiting (Events)
    Description
    Total number of vomiting episodes over the three postoperative days.
    Time Frame
    3 postoperative days
    Title
    Patient Reported Pain by VAS Scale
    Description
    Patients will rate their pain by VAS scale 1 day post surgery. Scale is a 0 to 10 visual analog scale with 0 representing no pain and 10 representing severe pain.
    Time Frame
    Postoperative Day 1
    Title
    Patient Reported Pain by VAS Scale
    Description
    Patients will rate their pain by VAS scale 2 days post surgery. Scale is a 0 to 10 visual analog scale with 0 representing no pain and 10 representing severe pain.
    Time Frame
    Postoperative Day 2
    Title
    Patient Reported Pain by VAS Scale
    Description
    Patients will rate their pain by VAS scale 3 days post surgery. Scale is a 0 to 10 visual analog scale with 0 representing no pain and 10 representing severe pain.
    Time Frame
    Postoperative Day 3
    Title
    Number of Days Required for a Patient to Get Out of Bed
    Description
    Patients will be assessed each day following the day of surgery for the ability to get out of bed.
    Time Frame
    Assessed daily for up to 3 days post-surgery
    Title
    Number of Days Required for a Patient to Walk Unassisted
    Description
    Patients will be assessed each day following the day of surgery for the ability to walk unassisted
    Time Frame
    Assessed daily for up to 3 days post-surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Ability to give written informed consent Scheduled for open abdominal surgery American Society of Anesthesiologists physical status 1 to 3 Exclusion Criteria: Inability to understand the study or provide written informed consent Inability to follow protocol instructions Complicated history of chronic opioid use including daily use of opioids for a period greater than 2 weeks prior to surgery Allergy to local anesthetic agents Contraindication to regional nerve block such as: Bleeding disorder Sepsis Infection at site of block Body Mass Index (BMI) >40 Pregnancy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Joshua Herskovic, MD
    Organizational Affiliation
    Midwestern Regional Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    TAP Block for Postoperative Pain Control

    We'll reach out to this number within 24 hrs