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Postoperative Analgesia After Caesarean Section Under ALR: TAP Block Versus Catheter Scar Infiltration

P

Public Assistance-Hospitals of Marseille (AP-HM)

Status and phase

Unknown
Phase 3

Conditions

Scheduled Caesarian Section

Treatments

Device: The infiltration continues catheter
Drug: Ropivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT02184559
2011-005690-23
2011-38 (Other Identifier)

Details and patient eligibility

About

The purpose of the multimodal postoperative analgesia is to improve the quality of analgesia and reduce side effects of morphine (nausea, vomiting, sedation, urinary retention, respiratory depression ...). In the case of caesarean sections, the quality of analgesia allows one hand to improve the mother-child relationship and the quality of breastfeeding, the other to reduce the risk of postpartum depression and chronic pain . Two methods of administration of local anesthetics have been proven effective for analgesia of the abdominal wall under umbilical: The Transversus Abdominal Block Plan (TAP Block) and infiltration of the scar continues operating. The TAP block was performed under ultrasound guidance by the anesthesiologist after the intervention in a single injection of local anesthetic in the abdominal wall and has a period of limited and variable. The infiltration continues catheter is placed by the surgeon before closing the wound and allows the infusion of local anesthetics for 48 hours.

The purpose of this study was to compare morphine consumption between both techniques, and the quality of analgesia and side effects of morphine

Enrollment

60 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Woman whose age is 18 years
  • Encircled Woman requiring a scheduled(programmed) caesarian, under spinal anesthesia or died combined(organized) spinal anesthesia
  • Woman ASA I and II
  • Term = 37 LIMITED COMPANIES
  • Woman primipare or not
  • Woman having signed an informed consent writes and making a commitment to respect the instructions of the protocol

Exclusion criteria

  • Minor Woman
  • Woman presenting a contraindication to the anesthesia périmédullaire: constitutional or acquired disorders(confusions) of the haemostasis, the allergy in the local anesthetics, the infectious context (hypertherm > 38.5 ° C)
  • Woman presenting an intolerance or an allergy known about the morphine in the paracetamol or in AIN
  • The surgical histories of laparotomy
  • The morbid obesity BMI > 35
  • Dysgravidies
  • Woman not being affiliated to the national insurance scheme
  • Woman under legal protection
  • Woman not having signed an informed consent

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

TAP block
Experimental group
Treatment:
Drug: Ropivacaine
infiltration continues
Active Comparator group
Treatment:
Device: The infiltration continues catheter

Trial contacts and locations

1

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Central trial contact

aurelie BOURGOIN

Data sourced from clinicaltrials.gov

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