Comparison of Two Types of Pain Relief After Cesarean Delivery

Study Overview
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Brief Summary
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Women undergoing elective cesarean delivery, performed under a standard spinal anesthesia, will be randomized to undergo either TAP block or incisional infiltration with local anesthetic, in addition to standard postoperative analgesia comprising regular acetaminophen, nefopam and ketoprofen. Short acting oral morphine will be given as a rescue treatment in case of severe pain.

Official Title
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Comparison of Two Methods of Pain Relief After Cesarean Delivery: Transversus Abdominis Plane (TAP) Block Versus Incisional Infiltration With Local Anesthetic

Conditions
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Cesarean Section

Intervention / Treatment
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* Other: Transversus Abdominis Plane (TAP) Block
* Other: Incisional Infiltration of Local Anesthetic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: scheduled cesarean section performed under spinal anesthesia ASA I or II height above 1,55 m singleton pregnancy Exclusion Criteria: contre indication to a drug used in the study (levobupivacaine, ketoprofen, nefopam)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transversus Abdominis Plane (TAP) Block<br>Patients will receive a bilateral transversus abdominis plane block | Other: Transversus Abdominis Plane (TAP) Block<br>* Bilateral injection of levobupivacaine (20 mL, 3.75 mg/mL)<br>|
| Active Comparator: Incisional Infiltration of Local Anesthetic<br>Patients will receive an incisional infiltration with local anesthetic (continuous administration of levobupivacaïne during 48 hours) | Other: Incisional Infiltration of Local Anesthetic<br>* continuous administration of levobupivacaine (1,25 mg/mL,5 mL/h) during 48 hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| severity of postoperative pain |  | 48 postoperative hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| delay before the first rescue dose of morphine |  | 48 postoperative hours | 
| morphine requirement |  | 48 postoperative hours | 
| complication of each loco-regional technique |  | end of hospitalisation | 
| patient's satisfaction |  | end of hospitalisation | 
| length of hospital stay |  | end of hospitalisation | 
| occurrence of a neuropathic postoperative pain |  | 1 month postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cesarean section, continuous wound infiltration, transversus abdominis plane block