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

NCT02184559 | Unknown Phase 3

• 2 other identifiers: 2011-005690-232011-38
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Scheduled Caesarian Section

Outcome Measures

Primary Outcomes (1)

• Consumption morphinize

  the cosumption of morphinize is collected since the first hours of comsumption to the 48 th hours

  48 hours

Secondary Outcomes (1)

• Analgesic efficiency

  48 hours

Study Arms (2)

TAP block

EXPERIMENTAL

Drug: Ropivacaine

infiltration continues

ACTIVE COMPARATOR

Device: The infiltration continues catheter

Interventions

Ropivacaine DRUG

comparaison of two methods of administration for analgesia using the same drugs in the same indication after Caesarean section

TAP block

The infiltration continues catheter DEVICE

infiltration continues

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

RECRUITING

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• loic MONDOLONI

  Assistance Publique Hopitaux De Marseille

  STUDY DIRECTOR

Central Study Contacts

aurelie BOURGOIN

CONTACT

aurelie.bourgoin@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2014
• First Posted: July 9, 2014
• Study Start: February 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: February 1, 2015
• Last Updated: July 9, 2014

Record last verified: 2014-07

Locations

FR (1)