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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ronald George, IWK Health Centre
ClinicalTrials.gov Identifier:
NCT01261637
First received: December 15, 2010
Last updated: May 22, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Postoperative Pain
Drug: Saline placebo
Drug: Ropivicaine
Phase 4

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

Resource links provided by NLM:


Further study details as provided by IWK Health Centre:

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. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • NRS / QoR - 48 hour Opioid Consumption Side effects - nausea, sedation [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Persistant pain outcomes will be assessed at 30 days and 6 months using 5-minute SF-36 health survey. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 86
Study Start Date: July 2009
Study Completion Date: January 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0.25% Ropivicaine
0.25% ropivicaine (maximum 1.5mg/kg)
Drug: Ropivicaine
0.25% ropivicaine (maximum 1.5mg/kg)
Other Name: Naropin
Placebo Comparator: Placebo
20ml saline
Drug: Saline placebo
20ml saline

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01261637

Locations
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada
Sponsors and Collaborators
IWK Health Centre
Investigators
Principal Investigator: Dolores McKeen, MD MSc FRCPC IWK Health Centre
  More Information

No publications provided by IWK Health Centre

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ronald George, Primary Investigator, MD, FRCPC, Assistant Professor, IWK Health Centre
ClinicalTrials.gov Identifier: NCT01261637     History of Changes
Other Study ID Numbers: IWK-4518-2009, IWK REB 4518
Study First Received: December 15, 2010
Last Updated: May 22, 2013
Health Authority: Canada: Health Canada

Keywords provided by IWK Health Centre:
cesarean, pain, transversus abdominus plane block

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014