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Efficacy of TAP Block in Cesarean Section Patients

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ClinicalTrials.gov Identifier: NCT03493828
Recruitment Status : Completed
First Posted : April 11, 2018
Results First Posted : November 12, 2018
Last Update Posted : November 12, 2018
Sponsor:
Information provided by (Responsible Party):
Joel Yarmush, New York Methodist Hospital

Brief Summary:
TAP Block done with 2 different concentrations of bupivacaine and placebo

Condition or disease Intervention/treatment Phase
Pain Control Procedure: TAP block using Bupivacaine 0.5% Procedure: TAP block using Bupivacaine 0.25% Procedure: TAP block using Normal Saline Phase 3

Detailed Description:
TAP Block was done using 2 different concentrations of bupivacaine (0.5% and 0.25%) and placebo and the post operative sedation was measured in each arm and compared together.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Arm 1: Bupivacaine 05%, arm 2: Bupivacaine 0.25%, and arm 3: placebo (Normal saline)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The randomization sheet was given to someone who is not involved in the study, also the person who prepare the medicine is not involved in the study.
Primary Purpose: Treatment
Official Title: A Randomized Double Blinded Controlled Trial on the Efficacy of TAP Block in Cesarean Section Patients When Compared to Placebo
Study Start Date : June 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Bupivacaine

Arm Intervention/treatment
Active Comparator: TAP using Bupivacaine 0.5%
Following completion of the Cesarean delivery, the abdomen was aseptically prepped with ChloraPrep®. A Sonosite ultrasound machine (S-nerve) with a 14-8 MHz linear probe was used to visualize the lateral abdominal wall muscles and transversus abdominis plane. A 2 or 4 inch stimuplex (Braun) needle was advanced under ultrasound guidance to the transversus abdominis plane. After negative aspiration, 15 ml of Bupivacaine 0.5% was incrementally injected on each side. The spread of solution within the transversus abdominis plane was visualized with the ultrasound.
Procedure: TAP block using Bupivacaine 0.5%
Following completion of the Cesarean delivery, the abdomen was aseptically prepped with ChloraPrep®. A Sonosite ultrasound machine (S-nerve) with a 14-8 MHz linear probe was used to visualize the lateral abdominal wall muscles and transversus abdominis plane. A 2 or 4 inch stimuplex (Braun) needle was advanced under ultrasound guidance to the transversus abdominis plane. After negative aspiration, 15 ml of Bupivacaine 0.5% was incrementally injected on each side. The spread of solution within the transversus abdominis plane was visualized with the ultrasound.

Active Comparator: TAP using Bupivacaine 0.25%
Following completion of the Cesarean delivery, the abdomen was aseptically prepped with ChloraPrep®. A Sonosite ultrasound machine (S-nerve) with a 14-8 MHz linear probe was used to visualize the lateral abdominal wall muscles and transversus abdominis plane. A 2 or 4 inch stimuplex (Braun) needle was advanced under ultrasound guidance to the transversus abdominis plane. After negative aspiration, 15 ml of Bupivacaine 0.25% was incrementally injected on each side. The spread of solution within the transversus abdominis plane was visualized with the ultrasound.
Procedure: TAP block using Bupivacaine 0.25%
Following completion of the Cesarean delivery, the abdomen was aseptically prepped with ChloraPrep®. A Sonosite ultrasound machine (S-nerve) with a 14-8 MHz linear probe was used to visualize the lateral abdominal wall muscles and transversus abdominis plane. A 2 or 4 inch stimuplex (Braun) needle was advanced under ultrasound guidance to the transversus abdominis plane. After negative aspiration, 15 ml of Bupivacaine 0.25% was incrementally injected on each side. The spread of solution within the transversus abdominis plane was visualized with the ultrasound.

Placebo Comparator: Placebo
Following completion of the Cesarean delivery, the abdomen was aseptically prepped with ChloraPrep®. A Sonosite ultrasound machine (S-nerve) with a 14-8 MHz linear probe was used to visualize the lateral abdominal wall muscles and transversus abdominis plane. A 2 or 4 inch stimuplex (Braun) needle was advanced under ultrasound guidance to the transversus abdominis plane. After negative aspiration, 15 ml of normal saline was incrementally injected on each side. The spread of solution within the transversus abdominis plane was visualized with the ultrasound.
Procedure: TAP block using Normal Saline
Following completion of the Cesarean delivery, the abdomen was aseptically prepped with ChloraPrep®. A Sonosite ultrasound machine (S-nerve) with a 14-8 MHz linear probe was used to visualize the lateral abdominal wall muscles and transversus abdominis plane. A 2 or 4 inch stimuplex (Braun) needle was advanced under ultrasound guidance to the transversus abdominis plane. After negative aspiration, 15 ml of normal saline was incrementally injected on each side. The spread of solution within the transversus abdominis plane was visualized with the ultrasound.




Primary Outcome Measures :
  1. Effect of Transversus Abdominis Plane (TAP) Block Using Either 0.5% or 0.25% Bupivacaine on Analgesia for Cesarean Section Patients When Compared to Placebo. [ Time Frame: 0-24 hours ]
    The total the number of Patient Controlled Analgesia (PCA) boluses used by the patients postoperatively within 24 hours



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy pregnant women

Exclusion Criteria:

  • Allergy to local anesthetics

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): NCT03493828


Locations
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United States, New York
New York Methodist Hospital
Brooklyn, New York, United States, 11215
Sponsors and Collaborators
New York Methodist Hospital
Investigators
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Study Director: Adel Guirguis, MD, MS New York Presbyterian Brooklyn Methodist Hospital

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Responsible Party: Joel Yarmush, MD, New York Methodist Hospital
ClinicalTrials.gov Identifier: NCT03493828     History of Changes
Other Study ID Numbers: TAP2013
First Posted: April 11, 2018    Key Record Dates
Results First Posted: November 12, 2018
Last Update Posted: November 12, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share IPD with other researchers

Additional relevant MeSH terms:
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Chlorhexidine
Chlorhexidine gluconate
Bupivacaine
Pharmaceutical Solutions
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents