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

IWK Health Centre

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain

Treatments: Drug: Saline placebo; Drug: Ropivicaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01261637

IWK REB 4518

IWK-4518-2009

Details and patient eligibility

About

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.

Enrollment: 86 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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86 participants in 2 patient groups, including a placebo group

0.25% Ropivicaine

Experimental group

Description:

0.25% ropivicaine (maximum 1.5mg/kg)

Treatment:

Drug: Ropivicaine

Placebo

Placebo Comparator group

Description:

20ml saline

Treatment:

Drug: Saline placebo