Clinical trial NCT01751256: Additional Effect of Wound Infiltration After Cesarean Section With Optimal Standard Analgesia
Official title: Levobupivacaine Continuous Wound Infiltration and Optimal Standard Analgesia Versus Optimal Standard Analgesia Alone After Cesarean Section.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Anesthesia, Local
Breast Feeding
Keywords: Postcesarean Section
Postoperative Pain
Care, Postoperative
Anesthesia, Local
Breast Feeding
Morphine
Pain Measurement
levobupivacaine
Lead sponsor: Poissy-Saint Germain Hospital
Sponsor class: OTHER
First posted: 2012-12-17
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative morphine consumption
timeFrame: 24 first hours after cesarean section
Secondary outcomes:
measure: Pain at mobilization
timeFrame: 4, 8, 12, 16, 20, 24, 36, 48 and 78 hours after skin closure, entrance and exit from the recovery room
measure: Early walking
timeFrame: in the 72 first hours after skin closure
measure: Resumption of gastrointestinal function
timeFrame: First 72 hours after skin closure
measure: Treatment tolerance
timeFrame: First 72 hours after skin closure
measure: Maternal satisfaction
timeFrame: 2 days after skin closure
measure: Health staff workload
timeFrame: For the 48 first hours after skin closure
measure: Wound infections
timeFrame: the first 10 days after skin closure
measure: Local anaesthetic systemic toxicity
timeFrame: During the first 48 hours after skin closure
measure: Discomfort due to material
timeFrame: At catheter retrieval
measure: Technical problems related to the catheter
timeFrame: During the 48 first hours after skin closure
measure: Pain at rest
timeFrame: 4, 8, 12, 16, 20, 24, 36, 48 and 78 hours after skin closure, entrance and exit from the recovery room
measure: Comfort with Breast Feeding
timeFrame: For the the 48 first hours after skin closure
measure: All cause morbidity
timeFrame: For the first 10 days after skin closure
Other outcomes:
Locations:
city: Poissy
country: France
facility: Poissy Saint Germain en Laye Hospital
Study officials:
affiliation: Poissy-Saint Germain Hospital
name: Claude JOLLY, MD
role: PRINCIPAL_INVESTIGATOR
References: