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Transversus Abdominis Plane (TAP) Block for Post Caesarian Pain

NCT ID: NCT01986049

Last Updated: 2021-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Obstetrical Complications From Sedation During Parturition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Bupivicaine 0.5%

Drug Bupivacaine 0.5%

Group Type EXPERIMENTAL

Bupivicaine

Intervention Type DRUG

Bupivicaine 0.25%

Drug Bupivacaine 0.25%

Group Type EXPERIMENTAL

Bupivicaine

Intervention Type DRUG

Normal Saline

Saline Normal

Group Type PLACEBO_COMPARATOR

Bupivicaine

Intervention Type DRUG

Interventions

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Bupivicaine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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New York Presbyterian Brooklyn Methodist Hospital

OTHER

Sponsor Role lead

Responsible Party

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Joel Yarmush

Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jonathan Weinberg, MD

Role: STUDY_DIRECTOR

New York Methodist Hospital Hospital

Locations

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New Yoyk Methodist Hospital

Brooklyn, New York, United States

Site Status

Countries

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United States

Other Identifiers

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IRBNet # 367320

Identifier Type: -

Identifier Source: org_study_id