Comparison of Two Methods of Pain Relief After Cesarean Delivery: Transversus Abdominis Plane (TAP) Block Versus Incisional Infiltration With Local Anesthetic
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Hopital Foch
- Enrollment
- 77
- Locations
- 1
- Primary Endpoint
- severity of postoperative pain
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- 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)
Arms & Interventions
Transversus Abdominis Plane (TAP) Block
Patients will receive a bilateral transversus abdominis plane block
Intervention: Transversus Abdominis Plane (TAP) Block (Other)
Incisional Infiltration of Local Anesthetic
Patients will receive an incisional infiltration with local anesthetic (continuous administration of levobupivacaïne during 48 hours)
Intervention: Incisional Infiltration of Local Anesthetic (Other)
Outcomes
Primary Outcomes
severity of postoperative pain
Time Frame: 48 postoperative hours
Secondary Outcomes
- 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)