Comparison of Two Types of Pain Relief After Cesarean Delivery

Phase 4

Terminated

• Conditions: Cesarean Section
• Interventions: Other: Incisional Infiltration of Local Anesthetic; Other: Transversus Abdominis Plane (TAP) Block

• Registration Number: NCT01151943
• Lead Sponsor: Hopital Foch

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-06-24
• Study First Submitted QC: 2010-06-28
• Study First Posted: 2010-06-29
• Study Start: 2010-10
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-02
• Last Update Posted: 2016-11-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 77

Inclusion Criteria

• scheduled cesarean section performed under spinal anesthesia
• ASA I or II
• height above 1,55 m
• singleton pregnancy

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Exclusion Criteria

• contre indication to a drug used in the study (levobupivacaine, ketoprofen, nefopam)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Incisional Infiltration of Local Anesthetic	Incisional Infiltration of Local Anesthetic	Patients will receive an incisional infiltration with local anesthetic (continuous administration of levobupivacaïne during 48 hours)
Transversus Abdominis Plane (TAP) Block	Transversus Abdominis Plane (TAP) Block	Patients will receive a bilateral transversus abdominis plane block

Primary Outcome Measures

Name	Time	Method
severity of postoperative pain	48 postoperative hours

Secondary Outcome Measures

Name	Time	Method
occurrence of a neuropathic postoperative pain	1 month postoperatively
patient's satisfaction	end of hospitalisation
length of hospital stay	end of hospitalisation
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

Trial Locations

Locations (1)

Hôpital Foch; 🇫🇷 Suresnes, France