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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Saline placebo
* Drug: Ropivicaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.25% Ropivicaine<br>0.25% ropivicaine (maximum 1.5mg/kg) | Drug: Ropivicaine<br>* 0.25% ropivicaine (maximum 1.5mg/kg)<br>* Other names: Naropin;|
| Placebo Comparator: Placebo<br>20ml saline | Drug: Saline placebo<br>* 20ml saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NRS / QoR - 48 hour Opioid Consumption Side effects - nausea, sedation |  | 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. |  | 24 hours | 
| Persistant pain outcomes will be assessed at 30 days and 6 months using 5-minute SF-36 health survey. |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cesarean, pain, transversus abdominus plane block