Efficacy of the Transversus Abdominus Plane (TAP) Block for Post-Cesarean Delivery Analgesia
Determination of the Efficay of the Transversus Abdominis Plane (TAP) Block as Part of a Multimodal Regimen for Post-cesarean Delivery Analgesia: a Double Blinded Placebo-controlled Study.
2 other identifiers
interventional
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable pain
Started Dec 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 12, 2007
CompletedFirst Posted
Study publicly available on registry
December 14, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedJuly 30, 2009
July 1, 2009
9 months
December 12, 2007
July 29, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain score by visual analogue scale (VAS) on movement at 24 hours postoperatively.
24 hours
Secondary Outcomes (5)
Pain at rest and on movement by VAS at 6, 12, 24 & 48 hours postoperatively.
48 hours
Opioid consumption at 6, 12, 24 & 48 hours postoperatively.
48 hours
Time to first maternal request for supplemental analgesia.
48 hours
Maternal satisfaction with pain management on a scale of 0-10, at 6, 12, 24 and 48 hours postoperatively.
48 hours
Presence of pain 6 weeks postoperatively.
6 weeks
Study Arms (2)
1
ACTIVE COMPARATORRopivacaine
2
PLACEBO COMPARATORPlacebo
Interventions
2 injections of 20mL 0.375% ropivacaine - one given on each side.
Eligibility Criteria
You may qualify if:
- Women undergoing elective cesarean delivery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jose CA Carvalho, MD
MOUNT SINAI HOSPITAL
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 12, 2007
First Posted
December 14, 2007
Study Start
December 1, 2007
Primary Completion
September 1, 2008
Study Completion
November 1, 2008
Last Updated
July 30, 2009
Record last verified: 2009-07