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

Postoperative Pain Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01261637
• Other study ID #: IWK-4518-2009
• Secondary ID: IWK REB 4518
• Status: Completed
• Phase: Phase 4
• First received: December 15, 2010
• Last updated: May 22, 2013
• Start date: July 2009
• Est. completion date: January 2011

Study information

• Verified date: May 2013
• Source: IWK Health Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: January 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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

Locations

Country	Name	City	State
Canada	IWK Health Centre	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
IWK Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	NRS / QoR - 48 hour Opioid Consumption Side effects - nausea, sedation		48 hours	No
Secondary	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	No
Secondary	Persistant pain outcomes will be assessed at 30 days and 6 months using 5-minute SF-36 health survey.		6 months	No