Comparison of Two Types of Pain Relief After Cesarean Delivery

Cesarean Section Clinical Trial

— Cesar-Dol  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01151943
• Other study ID #: 2010/15
• Secondary ID: 2010-019662-88
• Status: Terminated
• Phase: Phase 4
• First received: June 24, 2010
• Last updated: November 2, 2016
• Start date: October 2010
• Est. completion date: July 2012

Study information

• Verified date: November 2016
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 77
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cesarean Section

Intervention

Other:
• Transversus Abdominis Plane (TAP) Block
Bilateral injection of levobupivacaine (20 mL, 3.75 mg/mL)
• Incisional Infiltration of Local Anesthetic
continuous administration of levobupivacaine (1,25 mg/mL,5 mL/h) during 48 hours.

Locations

Country	Name	City	State
France	Hôpital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	severity of postoperative pain		48 postoperative hours	No
Secondary	delay before the first rescue dose of morphine		48 postoperative hours	No
Secondary	morphine requirement		48 postoperative hours	No
Secondary	complication of each loco-regional technique		end of hospitalisation	No
Secondary	patient's satisfaction		end of hospitalisation	No
Secondary	length of hospital stay		end of hospitalisation	No
Secondary	occurrence of a neuropathic postoperative pain		1 month postoperatively	No