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Efficacy of the Transversus Abdominus Plane (TAP) Block for Post-Cesarean Delivery Analgesia

NCT ID: NCT00573963

Last Updated: 2009-07-30

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

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2008-11-30

Brief Summary

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The purpose of this study is to determine if patients having the transversus abdominal place (TAP) block at the end of a cesarean delivery have less pain in the post-delivery period than those who do not. Freezing medication is injected between the layers of muscle on either side of the belly, to freeze the nerves that carry pain stimuli from an abdominal wound. This technique has been useful for many abdominal operations, and has recently been studied in cesarean sections, however more information is needed.

Detailed Description

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A cesarean section is a surgical procedure and, like all surgeries, there is pain after the operation. The purpose of this study is to find out if patients have less pain after a cesarean delivery when they receive an injection of local anesthetic on either side of their abdomen, into the plane of the transversus abdominis muscle. We are also interested in whether or not this injection decreases the need for other pain-killing medication during this time.

Patients will randomly be assigned to receive either local anesthetic or a placebo. In addition, all patients will receive the usual standard of care and medication for pain. At 6, 12, 24 and 48 hours after the operation, patients will be asked about their pain and satisfaction with pain management. The risk of side effects is very low, as the block is done in an area with low blood supply. We propose that the addition of the TAP block to the current multi-modal regimen of post-cesarean pain management will reduce pain scores and requests for additional analgesia post-operatively, as well as increase patient satisfaction with their pain control.

Conditions

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Pain

Keywords

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Cesarean section

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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1

Ropivacaine

Group Type ACTIVE_COMPARATOR

ropivacaine

Intervention Type DRUG

2 injections of 20mL 0.375% ropivacaine - one given on each side.

2

Placebo

Group Type PLACEBO_COMPARATOR

saline solution

Intervention Type DRUG

2 injections of 20mL plain saline solution - one on each side.

Interventions

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ropivacaine

2 injections of 20mL 0.375% ropivacaine - one given on each side.

Intervention Type DRUG

saline solution

2 injections of 20mL plain saline solution - one on each side.

Intervention Type DRUG

Other Intervention Names

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Naropin

Eligibility Criteria

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Inclusion Criteria

* Women undergoing elective cesarean delivery

Exclusion Criteria

* Patients unable to communicate in English
* Patients with an American Society of Anesthesiologists (ASA) classification of 3 or higher
* Patients with contraindications to spinal anesthesia
* Patients with an allergy to ropivacaine, morphine, ketorolac or acetaminophen
* Patients who have taken any pain medication in the past 24 hours
* Patients with a BMI \> 40
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Samuel Lunenfeld Research Institute, Mount Sinai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mount Sinai Hospital

Principal Investigators

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Jose CA Carvalho, MD

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Locations

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Mount Sinai Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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07-0245-A

Identifier Type: -

Identifier Source: secondary_id

07-11

Identifier Type: -

Identifier Source: org_study_id