Cesar-Dol: Comparison of Two Types of Pain Relief After Cesarean Delivery

• Sponsor: Hopital Foch (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01151943
• Collaborator: (none)
• Enrollment: 77
• Location: 1
• Arms: 2
• Duration (Months): 21
• Patients Per Site Per Month: 3.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cesarean Section	Other: Transversus Abdominis Plane (TAP) Block; Other: Incisional Infiltration of Local Anesthetic	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 77 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparison of Two Methods of Pain Relief After Cesarean Delivery: Transversus Abdominis Plane (TAP) Block Versus Incisional Infiltration With Local Anesthetic
• Study Start Date: Oct 1, 2010
• Actual Primary Completion Date: Jul 1, 2012
• Actual Study Completion Date: Jul 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. severity of postoperative pain [48 postoperative hours]

Secondary Outcome Measures

1. delay before the first rescue dose of morphine [48 postoperative hours]

2. morphine requirement [48 postoperative hours]

3. complication of each loco-regional technique [end of hospitalisation]

4. patient's satisfaction [end of hospitalisation]

5. length of hospital stay [end of hospitalisation]

6. occurrence of a neuropathic postoperative pain [1 month postoperatively]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Foch	Suresnes		France	92150

Sponsors and Collaborators

• Hopital Foch

Investigators

• Study Chair: Marc Fischler, MD, Hôpital Foch

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hopital Foch
• ClinicalTrials.gov Identifier: NCT01151943
• Other Study ID Numbers: 2010/15; 2010-019662-88
• First Posted: Jun 29, 2010
• Last Update Posted: Nov 3, 2016
• Last Verified: Nov 1, 2016

• Keywords provided by Hopital Foch: cesarean section; continuous wound infiltration; transversus abdominis plane block
• Additional relevant MeSH terms: Anesthetics; Anesthetics, Local

Study Results

No Results Posted as of Nov 3, 2016