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