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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01986049
Recruitment Status : Completed
First Posted : November 18, 2013
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Joel Yarmush, New York Methodist Hospital

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

Condition or disease Intervention/treatment Phase
Obstetrical Complications From Sedation During Parturition Drug: Bupivicaine Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 3 Study Comparing Transversus Abdominis Plane Block After Caesarian Section Usin Bupivacaine 0.5% vs. Bupivacaine 0.25% vs. Placebo (Normal Saline).
Study Start Date : February 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Bupivicaine 0.5%
Drug Bupavacaine 0.5%
Drug: Bupivicaine
Experimental: Bupivicaine 0.25%
Drug Bupavacaine 0.25%
Drug: Bupivicaine
Placebo Comparator: Normal Saline
Saline Normal
Drug: Bupivicaine



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01986049


Locations
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United States, New York
New Yoyk Methodist Hospital
Brooklyn, New York, United States, 11215
Sponsors and Collaborators
New York Methodist Hospital
Investigators
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Study Director: Jonathan Weinberg, MD New York Methodist Hospital Hospital
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Responsible Party: Joel Yarmush, Anesthesiologist, New York Methodist Hospital
ClinicalTrials.gov Identifier: NCT01986049    
Other Study ID Numbers: IRBNet # 367320
First Posted: November 18, 2013    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018
Additional relevant MeSH terms:
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Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents