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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Ronald George, IWK Health Centre

ClinicalTrials.gov Identifier:

NCT01261637

First received: December 15, 2010

Last updated: May 22, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

December 15, 2010

Last Updated Date

May 22, 2013

Start Date ^ICMJE

July 2009

Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The primary outcome will be postoperative pain, measured by an NRS, the quality of recovery score (QoR) and a Self Assessment Diary in the first 24h postoperative period. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01261637 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

NRS / QoR - 48 hour Opioid Consumption Side effects - nausea, sedation [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
TAP block success rates and duration of block effect will be assessed using a patient diary completed every 2 hours while the patient is awake. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Persistant pain outcomes will be assessed at 30 days and 6 months using 5-minute SF-36 health survey. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Ultrasound Guided 0.25% Ropivacaine Transversus Abdominis Plane Block in Addition to Intrathecal Morphine and Multimodal Analgesia for the Management of Postoperative Pain Among Women Undergoing Cesarean Delivery.

Brief Summary

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Postoperative Pain

Intervention ^ICMJE

Drug: Saline placebo
20ml saline
Drug: Ropivicaine
0.25% ropivicaine (maximum 1.5mg/kg)

Other Name: Naropin

Study Arm (s)

Experimental: 0.25% Ropivicaine
0.25% ropivicaine (maximum 1.5mg/kg)

Intervention: Drug: Ropivicaine
Placebo Comparator: Placebo
20ml saline

Intervention: Drug: Saline placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2011

Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT01261637

Other Study ID Numbers ^ICMJE

IWK-4518-2009, IWK REB 4518

Has Data Monitoring Committee

Yes

Responsible Party

Ronald George, IWK Health Centre

Study Sponsor ^ICMJE

IWK Health Centre

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Dolores McKeen, MD MSc FRCPC

IWK Health Centre

Information Provided By

IWK Health Centre

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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