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Clinical Trials/NCT01151943
NCT01151943
Terminated
Phase 4

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

Hopital Foch1 site in 1 country77 target enrollmentOctober 2010

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Cesarean Section
Sponsor
Hopital Foch
Enrollment
77
Locations
1
Primary Endpoint
severity of postoperative pain
Status
Terminated
Last Updated
9 years ago

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.

Registry
clinicaltrials.gov
Start Date
October 2010
End Date
July 2012
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

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)

Study Sites (1)

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