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

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Saline placebo
Ropivicaine
Sponsored by
IWK Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring cesarean, pain, transversus abdominus plane block

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • IWK Health Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

0.25% Ropivicaine

Placebo

Arm Description

0.25% ropivicaine (maximum 1.5mg/kg)

20ml saline

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

NRS / QoR - 48 hour Opioid Consumption Side effects - nausea, sedation
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.
Persistant pain outcomes will be assessed at 30 days and 6 months using 5-minute SF-36 health survey.

Full Information

First Posted
December 15, 2010
Last Updated
May 22, 2013
Sponsor
IWK Health Centre
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1. Study Identification

Unique Protocol Identification Number
NCT01261637
Brief Title
Abdominal Wall Local Anesthesia to Maximize Postoperative Pain Control After Cesarean Delivery
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IWK Health Centre

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
cesarean, pain, transversus abdominus plane block

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.25% Ropivicaine
Arm Type
Experimental
Arm Description
0.25% ropivicaine (maximum 1.5mg/kg)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
20ml saline
Intervention Type
Drug
Intervention Name(s)
Saline placebo
Intervention Description
20ml saline
Intervention Type
Drug
Intervention Name(s)
Ropivicaine
Other Intervention Name(s)
Naropin
Intervention Description
0.25% ropivicaine (maximum 1.5mg/kg)
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
NRS / QoR - 48 hour Opioid Consumption Side effects - nausea, sedation
Time Frame
48 hours
Title
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
Title
Persistant pain outcomes will be assessed at 30 days and 6 months using 5-minute SF-36 health survey.
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dolores McKeen, MD MSc FRCPC
Organizational Affiliation
IWK Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
24764186
Citation
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.
Results Reference
derived

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

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