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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01261637
Recruitment Status : Completed
First Posted : December 16, 2010
Last Update Posted : May 23, 2013
Information provided by (Responsible Party):
Ronald George, 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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Saline placebo Drug: Ropivicaine Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : July 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 Measures :
  1. NRS / QoR - 48 hour Opioid Consumption Side effects - nausea, sedation [ Time Frame: 48 hours ]
  2. 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 ]
  3. Persistant pain outcomes will be assessed at 30 days and 6 months using 5-minute SF-36 health survey. [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01261637

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Ronald George, Primary Investigator, MD, FRCPC, Assistant Professor, IWK Health Centre Identifier: NCT01261637     History of Changes
Other Study ID Numbers: IWK-4518-2009
IWK REB 4518
First Posted: December 16, 2010    Key Record Dates
Last Update Posted: May 23, 2013
Last Verified: May 2013

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

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms