Abdominal Wall Local Anesthesia to Maximize Postoperative Pain Control After Cesarean Delivery

NCT ID: NCT01261637

Last Updated: 2013-05-23

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

PHASE4

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-01-31

Brief Summary

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This study has been designed to determine if women undergoing cesarean delivery with spinal anesthesia and routine pain management who also have an additional ultrasound guided transversus abdominis plane (TAP)block using ropivacaine have better pain relief and a better quality of recovery than women who don't have the additional TAP block. Maximizing pain relief using ultrasound guided TAP blocks in addition to neuraxial opioids, NSAIDs, and acetaminophen may improve acute pain outcomes, reduce adverse side effects, and potentially reduce chronic pain.

Detailed Description

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Conditions

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Postoperative Pain

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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0.25% Ropivicaine

0.25% ropivicaine (maximum 1.5mg/kg)

Group Type EXPERIMENTAL

Ropivicaine

Intervention Type DRUG

0.25% ropivicaine (maximum 1.5mg/kg)

Placebo

20ml saline

Group Type PLACEBO_COMPARATOR

Saline placebo

Intervention Type DRUG

20ml saline

Interventions

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Saline placebo

20ml saline

Intervention Type DRUG

Ropivicaine

0.25% ropivicaine (maximum 1.5mg/kg)

Intervention Type DRUG

Other Intervention Names

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Naropin

Eligibility Criteria

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Inclusion Criteria

* Non-emergent CD with planned spinal anesthesia
* American Society of Anesthesia physical status class I \& II
* Age ≥ 18 years
* Term gestational age (≥ 37 weeks)
* English-speaking

Exclusion Criteria

* Morbid Obesity (BMI³ 45 kg/m2)
* Laboring women
* Emergency CD
* Severe maternal cardiac disease
* Subjects with significant obstetric co-morbidities
* Failed spinal anesthesia
* Patient enrollment in another study involving medication within 30 days of CD
* Any other condition which may impair ability to cooperate with data collection
* Height less than 152 cm (5'0")
* Fetal anomalies or intrauterine fetal death
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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IWK Health Centre

OTHER

Sponsor Role lead

Responsible Party

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Ronald George

Primary Investigator, MD, FRCPC, Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dolores McKeen, MD MSc FRCPC

Role: PRINCIPAL_INVESTIGATOR

IWK Health Centre

Locations

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IWK Health Centre

Halifax, Nova Scotia, Canada

Site Status

Countries

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Canada

References

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McKeen DM, George RB, Boyd JC, Allen VM, Pink A. Transversus abdominis plane block does not improve early or late pain outcomes after Cesarean delivery: a randomized controlled trial. Can J Anaesth. 2014 Jul;61(7):631-40. doi: 10.1007/s12630-014-0162-5. Epub 2014 Apr 24.

Reference Type DERIVED
PMID: 24764186 (View on PubMed)

Other Identifiers

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IWK REB 4518

Identifier Type: -

Identifier Source: secondary_id

IWK-4518-2009

Identifier Type: -

Identifier Source: org_study_id

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