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Completed

NCT Number: NCT03493828

Efficacy of TAP Block in Cesarean Section Patients

TAP Block done with 2 different concentrations of bupivacaine and placebo

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Key information

Conditions

Pain Control Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

New York Methodist Hospital

Brooklyn, New York, 11215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy pregnant women

Exclusion criteria

  • Allergy to local anesthetics

Treatment and study plan

TAP block using Bupivacaine 0.5%

Procedure

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.

TAP block using Bupivacaine 0.25%

Procedure

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.

TAP block using Normal Saline

Procedure

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 outcomes

  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

Sponsors and collaborators

Lead sponsor

New York Presbyterian Brooklyn Methodist Hospital

Other

Registry information

Official study title

A Randomized Double Blinded Controlled Trial on the Efficacy of TAP Block in Cesarean Section Patients When Compared to Placebo

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 11, 2018
Registry last updated
Nov 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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