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

Phase 4

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Ropivicaine; Drug: Saline placebo

• Registration Number: NCT01261637
• Lead Sponsor: IWK Health Centre

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 available

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2010-07
• Study First Submitted: 2010-12-15
• Study First Submitted QC: 2010-12-15
• Study First Posted: 2010-12-16
• Study Completion: 2011-01
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-22
• Last Update Posted: 2013-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.25% Ropivicaine	Ropivicaine	0.25% ropivicaine (maximum 1.5mg/kg)
Placebo	Saline placebo	20ml saline

Primary Outcome Measures

Name	Time	Method
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.	24 hours

Secondary Outcome Measures

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

Trial Locations

Locations (1)

IWK Health Centre; 🇨🇦 Halifax, Nova Scotia, Canada