Efficacy of the Transversus Abdominus Plane (TAP) Block for Post-Cesarean Delivery Analgesia

Study Overview
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Brief Summary
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The purpose of this study is to determine if patients having the transversus abdominal place (TAP) block at the end of a cesarean delivery have less pain in the post-delivery period than those who do not. Freezing medication is injected between the layers of muscle on either side of the belly, to freeze the nerves that carry pain stimuli from an abdominal wound. This technique has been useful for many abdominal operations, and has recently been studied in cesarean sections, however more information is needed.

Detailed Description
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A cesarean section is a surgical procedure and, like all surgeries, there is pain after the operation. The purpose of this study is to find out if patients have less pain after a cesarean delivery when they receive an injection of local anesthetic on either side of their abdomen, into the plane of the transversus abdominis muscle. We are also interested in whether or not this injection decreases the need for other pain-killing medication during this time. Patients will randomly be assigned to receive either local anesthetic or a placebo. In addition, all patients will receive the usual standard of care and medication for pain. At 6, 12, 24 and 48 hours after the operation, patients will be asked about their pain and satisfaction with pain management. The risk of side effects is very low, as the block is done in an area with low blood supply. We propose that the addition of the TAP block to the current multi-modal regimen of post-cesarean pain management will reduce pain scores and requests for additional analgesia post-operatively, as well as increase patient satisfaction with their pain control.

Official Title
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Determination of the Efficay of the Transversus Abdominis Plane (TAP) Block as Part of a Multimodal Regimen for Post-cesarean Delivery Analgesia: a Double Blinded Placebo-controlled Study.

Conditions
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Pain

Intervention / Treatment
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* Drug: ropivacaine
* Drug: saline solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women undergoing elective cesarean delivery Exclusion Criteria: Patients unable to communicate in English Patients with an American Society of Anesthesiologists (ASA) classification of 3 or higher Patients with contraindications to spinal anesthesia Patients with an allergy to ropivacaine, morphine, ketorolac or acetaminophen Patients who have taken any pain medication in the past 24 hours Patients with a BMI > 40

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| Active Comparator: 1<br>Ropivacaine | Drug: ropivacaine<br>* 2 injections of 20mL 0.375% ropivacaine - one given on each side.<br>* Other names: Naropin;|
| Placebo Comparator: 2<br>Placebo | Drug: saline solution<br>* 2 injections of 20mL plain saline solution - one on each side.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score by visual analogue scale (VAS) on movement at 24 hours postoperatively. |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain at rest and on movement by VAS at 6, 12, 24 & 48 hours postoperatively. |  | 48 hours | 
| Opioid consumption at 6, 12, 24 & 48 hours postoperatively. |  | 48 hours | 
| Time to first maternal request for supplemental analgesia. |  | 48 hours | 
| Maternal satisfaction with pain management on a scale of 0-10, at 6, 12, 24 and 48 hours postoperatively. |  | 48 hours | 
| Presence of pain 6 weeks postoperatively. |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cesarean section