Efficacy of TAP Block in Cesarean Section Patients

NCT03493828 | Completed Phase 3 Results

• 1 other identifier: TAP2013
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

TAP Block done with 2 different concentrations of bupivacaine and placebo

Conditions

Pain Control

Outcome Measures

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.

  The total the number of Patient Controlled Analgesia (PCA) boluses used by the patients postoperatively within 24 hours

  0-24 hours

Study Arms (3)

TAP using Bupivacaine 0.5%

ACTIVE COMPARATOR

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%

TAP using Bupivacaine 0.25%

ACTIVE COMPARATOR

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%

Placebo

PLACEBO COMPARATOR

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

Interventions

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 using Bupivacaine 0.5%

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 using Bupivacaine 0.25%

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.

Placebo

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy pregnant women

You may not qualify if:

• Allergy to local anesthetics

Sponsors & Collaborators

• New York Presbyterian Brooklyn Methodist Hospital: lead

Study Sites (1)

New York Methodist Hospital

Brooklyn, New York, 11215, United States

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The investigators used epidural morphine in all 3 groups, so they were unable to assess whether TAP block in a multimodal analgesic regimen without the neuraxial opioids provide advantage over the multimodal analgesic regimen with neuraxial opioids.

Results Point of Contact

• Title: Dr Joel Yarmush
• Organization: New York Methodist Hospital

joelyarmush@gmail.com

(718) 780-3279

Study Officials

• Adel Guirguis, MD, MS

  New York Presbyterian Brooklyn Methodist Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Arm 1: Bupivacaine 05%, arm 2: Bupivacaine 0.25%, and arm 3: placebo (Normal saline)

Study Record Dates

• First Submitted: April 27, 2015
• First Posted: April 11, 2018
• Study Start: June 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 13, 2018
• Results First Posted: November 13, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)