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WithdrawnNCT01986049TAPBlockUpdated Oct 14, 2021

Transversus Abdominis Plane (TAP) Block for Post Caesarian Pain

A Phase 3 interventional study of Bupivicaine in Obstetrical Complications From Sedation During Parturition, sponsored by New York Presbyterian Brooklyn Methodist Hospital. Withdrawn at 1 site in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2021-10-14.

Sponsored by New York Presbyterian Brooklyn Methodist Hospital · Phase 3, Interventional, and Treatment

Why this study was withdrawn
We never collected data or started to recruit participants
Phase
Phase 3
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Female
01

Study summary

Adding TAP block with Bupivacaine may decrease the use of PCA bolus use after caesarean section for pain relief.

Read the detailed description

Participants in the study will be randomized to TAP block with 0.5% or 0.25% bupivacaine or with placebo (normal saline).

The number of PCA bolus used within 24 hours post cesarean section will be compared between the groups.

02

Conditions studied

  • Obstetrical Complications From Sedation During Parturition
03

In context

Lead sponsor

New York Presbyterian Brooklyn Methodist Hospital is the lead sponsor of 16 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Healthy pregnant (ASA II) patients presenting for planned Cesarean delivery at New York Methodist Hospital under combined spinal epidural anesthesia

Exclusion criteria

Exclusion Criteria:

  • They are unable or are unwilling to take part in the study
  • They have a history of allergy to any of the medications to be used in the study
  • They have a history of drug abuse or chronic pain or opioid use
  • They weigh less than 60kg
  • They have a multiple gestation, placental disease, preeclampsia other disease of pregnancy
  • They have a contraindication to neuraxial anesthesia (i.e., bleeding problems, bacteremia, etc.)
  • They are unable to understand instructions or questions related to the study
  • ASA III or IV
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Bupivicaine 0.5%

    Drug Bupivacaine 0.5%

    Drug: Bupivicaine

  • Experimental
    Bupivicaine 0.25%

    Drug Bupivacaine 0.25%

    Drug: Bupivicaine

  • Placebo comparator
    Normal Saline

    Saline Normal

    Drug: Bupivicaine

Interventions

06

What researchers measure

Primary outcomes

  1. Transversus Abdominis Plane (TAP) Block for Post Caesarean Pain

    In Patient Controlled analgesia (PCA) system, the patient receives a preset dose of morphine by pressing a button on a computerized pump that is connected to an IV catheter. With PCA the patient may receive a small continuous flow of morphine and add more morphine as needed to provide a more constant level of comfort. In this study, we will compare the number of PCAs used by the participants in each arm

    Time frame: The first post operative 24 hours

Secondary outcomes

  1. Decrease in the pain score as measured by Visual Analog Scale (VAS)

    Visual Analog Scale (VAS) is a numeric scale to measure the pain intensity from 0 to 10, where 0 = no pain, (1-3) = mild pain, (4-6) = moderate pain, and (7-10) = severe pain. The worst imaginable pain = 10

    Time frame: The first post operative 24 hours

07

Study locations

1 site
  • New Yoyk Methodist Hospital
    Brooklyn, New York 11215, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01986049
Lead sponsor
New York Presbyterian Brooklyn Methodist Hospital
Responsible party
Joel Yarmush (Anesthesiologist, New York Presbyterian Brooklyn Methodist Hospital) — Principal investigator
First posted
Nov 18, 2013
Start date
Feb 2013
Primary completion
Aug 2013
Completion
Aug 2013
Last update
Oct 14, 2021

Study contacts

Jonathan Weinberg, MD
study director · New York Methodist Hospital Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Bupivacaine

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