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

NCT ID: NCT02184559

Last Updated: 2014-07-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2015-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TAP block

Group Type: EXPERIMENTAL

Ropivacaine

Intervention Type: DRUG

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

infiltration continues

Group Type: ACTIVE_COMPARATOR

The infiltration continues catheter

Intervention Type: DEVICE

Interventions

Ropivacaine

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

Intervention Type: DRUG

The infiltration continues catheter

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

loic MONDOLONI

Role: STUDY_DIRECTOR

Assistance Publique Hopitaux De Marseille

Locations

Assistance Publique Hopitaux de Marseille

Marseille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

aurelie BOURGOIN

Role: CONTACT

aurelie.bourgoin@ap-hm.fr

Facility Contacts

aurelie BOURGOIN

Role: primary

aurelie.bourgoin@ap-hm.fr

Other Identifiers

2011-38

Identifier Type: OTHER

Identifier Source: secondary_id

2011-005690-23

Identifier Type: -

Identifier Source: org_study_id