Efficacy of TAP Block in Cesarean Section Patients

New York Presbyterian Brooklyn Methodist Hospital

Status and phase: Completed; Phase 3

Conditions: Pain Control

Treatments: Procedure: TAP block using Normal Saline; Procedure: TAP block using Bupivacaine 0.5%; Procedure: TAP block using Bupivacaine 0.25%

Study type: Interventional

Funder types: Other

Identifiers

NCT03493828

TAP2013

Details and patient eligibility

About

TAP Block done with 2 different concentrations of bupivacaine and placebo

Full 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.

Enrollment: 60 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy pregnant women

Exclusion criteria

• Allergy to local anesthetics

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups, including a placebo group

TAP using Bupivacaine 0.5%

Active Comparator group

Description:

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.

Treatment:

Procedure: TAP block using Bupivacaine 0.5%

TAP using Bupivacaine 0.25%

Active Comparator group

Description:

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.

Treatment:

Procedure: TAP block using Bupivacaine 0.25%

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Procedure: TAP block using Normal Saline