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Efficacy of TAP Block in Cesarean Section Patients

N

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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