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

Hopital Foch

Status and phase: Terminated; Phase 4

Conditions: Cesarean Section

Treatments: Other: Incisional Infiltration of Local Anesthetic; Other: Transversus Abdominis Plane (TAP) Block

Study type: Interventional

Funder types: Other

Identifiers

NCT01151943

2010-019662-88 (EudraCT Number)

2010/15

Details and patient eligibility

About

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.

Enrollment: 77 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

77 participants in 2 patient groups

Transversus Abdominis Plane (TAP) Block

Experimental group

Description:

Patients will receive a bilateral transversus abdominis plane block

Treatment:

Other: Transversus Abdominis Plane (TAP) Block

Incisional Infiltration of Local Anesthetic

Active Comparator group

Description:

Patients will receive an incisional infiltration with local anesthetic (continuous administration of levobupivacaïne during 48 hours)

Treatment:

Other: Incisional Infiltration of Local Anesthetic