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

Phase 4

Completed

• Conditions: Postoperative Pain; Anesthesia, Local; Breast Feeding
• Interventions: Device: Continuous wound infiltration

• Registration Number: NCT01751256
• Lead Sponsor: Poissy-Saint Germain Hospital

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

Detailed Description

Continuous wound infiltration with local anaesthetic has been shown as a safe and opioid-sparing analgesic method after caesarean section with minimal standard analgesia. We aim to evaluate if this benefit remains when an optimal analgesia is used.

Primary outcome is morphine consumption. Secondary outcomes is pain scores, maternal recovery including breastfeeding, side effects of morphine, nurse workload and maternal satisfaction.

Patients scheduled for caesarean delivery will be eligible for the study.

Patients with emergency caesarean delivery, contraindication to analgesic drugs, hemostasis disorder, ongoing infection, diabetes treated with insulin or chronic opioid use will be excluded from the study.

One group will receive standard analgesia including celecoxib and intravenous morphine for 24 hours with Patient Controlled Analgesia pump. The other group will receive the same standard analgesia with additional levobupivacaine initial bolus followed by a continuous subfascial infiltration of 1.25 mg/ml at 5 ml/h for 48 hours through a multiperforated catheter connected to an elastomeric pump.

Total morphine consumption, pain and any associated complications will be recorded for 72 hours. Women wil be asked to fulfill a questionnaire on the second day after cesarean section, assessing recovery, satisfaction and breastfeeding comfort.

Study Timeline

• Study Start: 2010-06
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-12
• Study First Submitted: 2012-12-13
• Study First Submitted QC: 2012-12-14
• Last Update Submitted: 2012-12-14
• Study First Posted: 2012-12-17
• Last Update Posted: 2012-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 68

Inclusion Criteria

• Scheduled cesarean section

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous wound infiltration	Continuous wound infiltration	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).

Primary Outcome Measures

Name	Time	Method
Postoperative morphine consumption	24 first hours after cesarean section	Quantity of morphine injected by the patient controlled analgesia pump

Secondary Outcome Measures

Name	Time	Method
Pain at mobilization	4, 8, 12, 16, 20, 24, 36, 48 and 78 hours after skin closure, entrance and exit from the recovery room	Numerical pain scale during mobilization
Early walking	in the 72 first hours after skin closure	Time taken for early walking
Resumption of gastrointestinal function	First 72 hours after skin closure	Interval from the end of surgery until the first gas from the intestinal tract
Treatment tolerance	First 72 hours after skin closure	Nausea, vomiting, pruritus, excessive sedation
Maternal satisfaction	2 days after skin closure	Analogic numerical scale on a specific form
Health staff workload	For the 48 first hours after skin closure	Number of intervention for nursing, breastfeeding help, and cesarean wound dressing change
Wound infections	the first 10 days after skin closure	Number of wound infection needing specific cares appeared during the observation time
Local anaesthetic systemic toxicity	During the first 48 hours after skin closure	Every adverse effect attributed to local anaesthetic by an skilled anesthesiologist
Discomfort due to material	At catheter retrieval	Discomfort caused by the material and pain at retrieval of the catheter, assessed by an analogic scale on a specific form
Technical problems related to the catheter	During the 48 first hours after skin closure	Premature withdrawal or occlusion of the catheter
Pain at rest	4, 8, 12, 16, 20, 24, 36, 48 and 78 hours after skin closure, entrance and exit from the recovery room	Numerical pain scale at rest
Comfort with Breast Feeding	For the the 48 first hours after skin closure	Analogic numerical scale on a specific form
All cause morbidity	For the first 10 days after skin closure	Postpartum hemorrhage or every adverse event occurred during the observation period.

Trial Locations

Locations (1)

Poissy Saint Germain en Laye Hospital; 🇫🇷 Poissy, France