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OpenTrials
Completed

NCT Number: NCT01261637

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

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

IWK Health Centre

Halifax, Nova Scotia, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saline placebo

Drug

20ml saline

ropivicaine

Drug

0.25% ropivicaine (maximum 1.5mg/kg)

Other names: Naropin

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

IWK Health Centre

Other

Registry information

Official study 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.

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Dec 16, 2010
Registry last updated
May 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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