Study Stopped
We never collected data or started to recruit participants
Transversus Abdominis Plane (TAP) Block for Post Caesarian Pain
TAPBlock
Phase 3 Study Comparing Transversus Abdominis Plane Block After Caesarian Section Usin Bupivacaine 0.5% vs. Bupivacaine 0.25% vs. Placebo (Normal Saline).
1 other identifier
interventional
N/A
1 country
1
Brief Summary
Adding TAP block with Bupivacaine may decrease the use of PCA bolus use after caesarean section for pain relief.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2013
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 7, 2013
CompletedFirst Posted
Study publicly available on registry
November 18, 2013
CompletedOctober 14, 2021
August 1, 2019
6 months
November 7, 2013
October 13, 2021
Conditions
Outcome Measures
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
The first post operative 24 hours
Secondary Outcomes (1)
Decrease in the pain score as measured by Visual Analog Scale (VAS)
The first post operative 24 hours
Study Arms (3)
Bupivicaine 0.5%
EXPERIMENTALDrug Bupivacaine 0.5%
Bupivicaine 0.25%
EXPERIMENTALDrug Bupivacaine 0.25%
Normal Saline
PLACEBO COMPARATORSaline Normal
Interventions
Eligibility Criteria
You may qualify if:
- Healthy pregnant (ASA II) patients presenting for planned Cesarean delivery at New York Methodist Hospital under combined spinal epidural anesthesia
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New Yoyk Methodist Hospital
Brooklyn, New York, 11215, United States
Study Officials
- STUDY DIRECTOR
Jonathan Weinberg, MD
New York Methodist Hospital Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Anesthesiologist
Study Record Dates
First Submitted
November 7, 2013
First Posted
November 18, 2013
Study Start
February 1, 2013
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
October 14, 2021
Record last verified: 2019-08