Additional Effect of Wound Infiltration After Cesarean Section With Optimal Standard Analgesia

NCT01751256 | Completed Phase 4

• 1 other identifier: PoissyStGermainH
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine wether wound infiltration brings additional analgesia effect after cesarean section with optimal standard postoperative analgesia

Conditions

Postoperative Pain; Anesthesia, Local; Breast Feeding

Keywords

Postcesarean Section; Postoperative Pain; Care, Postoperative; Anesthesia, Local; Breast Feeding; Morphine; Pain Measurement; levobupivacaine

Outcome Measures

Primary Outcomes (1)

• Postoperative morphine consumption

  Quantity of morphine injected by the patient controlled analgesia pump

  24 first hours after cesarean section

Secondary Outcomes (13)

• Pain at mobilization

  4, 8, 12, 16, 20, 24, 36, 48 and 78 hours after skin closure, entrance and exit from the recovery room

• Early walking

  in the 72 first hours after skin closure

• Resumption of gastrointestinal function

  First 72 hours after skin closure

• Treatment tolerance

  First 72 hours after skin closure

• Maternal satisfaction

  2 days after skin closure

Study Arms (2)

Continuous wound infiltration

EXPERIMENTAL

Subfascial continuous wound infiltration with Levobupivacaine: bolus 50mg and 6.25mg/h for 48 hours through a multiperforated catheter, in addition to Celecoxib 200mg twice a day, paracetamol 1g four times a day, Nefopam 20mg four times a day, and intravenous morphine for 24 hours with Patient Controlled Analgesia pump (1.2mg by bolus, 7 minutes lockout period).

Device: Continuous wound infiltration

Control

NO INTERVENTION

Celecoxib 200mg twice a day, paracetamol 1g four times a day, Nefopam 20mg four times a day, and intravenous morphine for 24 hours with Patient Controlled Analgesia pump (1.2mg by bolus, 7 minutes lockout period).

Interventions

Continuous wound infiltration DEVICE

Subfascial continuous wound infiltration with Levobupivacaine: bolus 50mg and 6.25mg/h for 48 hours through a multiperforated catheter, in addition to Celecoxib 200mg twice a day, paracetamol 1g four times a day, Nefopam 20mg four times a day, and intravenous morphine for 24 hours with Patient Controlled Analgesia pump (1.2mg by bolus, 7 minutes lockout period).

Continuous wound infiltration

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Scheduled cesarean section

You may not qualify if:

• Emergency cesarean section
• Contraindication to opioids, paracetamol, or local anaesthetic
• Ongoing infection
• Coagulation disorders
• Diabetes treated with insulin
• Chronic opioid use

Sponsors & Collaborators

• Poissy-Saint Germain Hospital: lead

Study Sites (1)

Poissy Saint Germain en Laye Hospital

Poissy, 78300, France

Location

MeSH Terms

Conditions

Pain, Postoperative; Breast Feeding

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Feeding Behavior; Behavior

Study Officials

• Claude JOLLY, MD

  Poissy-Saint Germain Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 13, 2012
• First Posted: December 17, 2012
• Study Start: June 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 17, 2012

Record last verified: 2012-12

Locations

FR (1)