Transversus Abdominis Plane (TAP) Block for Post Caesarian Pain (TAPBlock)

October 13, 2021 updated by: Joel Yarmush, New York Presbyterian Brooklyn Methodist Hospital

Phase 3 Study Comparing Transversus Abdominis Plane Block After Caesarian Section Usin Bupivacaine 0.5% vs. Bupivacaine 0.25% vs. Placebo (Normal Saline).

Adding TAP block with Bupivacaine may decrease the use of PCA bolus use after caesarean section for pain relief.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Participants in the study will be randomized to TAP block with 0.5% or 0.25% bupivacaine or with placebo (normal saline).

The number of PCA bolus used within 24 hours post cesarean section will be compared between the groups.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Brooklyn, New York, United States, 11215
        • New Yoyk Methodist Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Healthy pregnant (ASA II) patients presenting for planned Cesarean delivery at New York Methodist Hospital under combined spinal epidural anesthesia

Exclusion Criteria:

  • They are unable or are unwilling to take part in the study
  • They have a history of allergy to any of the medications to be used in the study
  • They have a history of drug abuse or chronic pain or opioid use
  • They weigh less than 60kg
  • They have a multiple gestation, placental disease, preeclampsia other disease of pregnancy
  • They have a contraindication to neuraxial anesthesia (i.e., bleeding problems, bacteremia, etc.)
  • They are unable to understand instructions or questions related to the study
  • ASA III or IV

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bupivicaine 0.5%
Drug Bupivacaine 0.5%
Drug: Bupivicaine
Experimental: Bupivicaine 0.25%
Drug Bupivacaine 0.25%
Drug: Bupivicaine
Placebo Comparator: Normal Saline
Saline Normal
Drug: Bupivicaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transversus Abdominis Plane (TAP) Block for Post Caesarean Pain
Time Frame: The first post operative 24 hours
In Patient Controlled analgesia (PCA) system, the patient receives a preset dose of morphine by pressing a button on a computerized pump that is connected to an IV catheter. With PCA the patient may receive a small continuous flow of morphine and add more morphine as needed to provide a more constant level of comfort. In this study, we will compare the number of PCAs used by the participants in each arm
The first post operative 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decrease in the pain score as measured by Visual Analog Scale (VAS)
Time Frame: The first post operative 24 hours
Visual Analog Scale (VAS) is a numeric scale to measure the pain intensity from 0 to 10, where 0 = no pain, (1-3) = mild pain, (4-6) = moderate pain, and (7-10) = severe pain. The worst imaginable pain = 10
The first post operative 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York Presbyterian Brooklyn Methodist Hospital

Investigators

  • Study Director: Jonathan Weinberg, MD, New York Methodist Hospital Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

November 7, 2013

First Submitted That Met QC Criteria

November 14, 2013

First Posted (Estimate)

November 18, 2013

Study Record Updates

Last Update Posted (Actual)

October 14, 2021

Last Update Submitted That Met QC Criteria

October 13, 2021

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRBNet # 367320

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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