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

IWK Health Centre86 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Postoperative Pain

Interventions

Saline placeboDRUG

20ml saline

RopivicaineDRUG

0.25% ropivicaine (maximum 1.5mg/kg)

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

IWK Health Centre

Halifax, Nova Scotia, Canada

Outcomes

Primary Outcomes

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

NRS / QoR - 48 hour Opioid Consumption Side effects - nausea, sedation

Time frame: 48 hours

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

Persistant pain outcomes will be assessed at 30 days and 6 months using 5-minute SF-36 health survey.

Time frame: 6 months

Data from ClinicalTrials.gov

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