Levobupivacaine Continuous Wound Infiltration and Optimal Standard Analgesia Versus Optimal Standard Analgesia Alone After Cesarean Section.
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Postoperative Pain
- Sponsor
- Poissy-Saint Germain Hospital
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- Postoperative morphine consumption
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Claude JOLLY
MD
Poissy-Saint Germain Hospital
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
Outcomes
Primary Outcomes
Postoperative morphine consumption
Time Frame: 24 first hours after cesarean section
Quantity of morphine injected by the patient controlled analgesia pump
Secondary Outcomes
- Technical problems related to the catheter(During the 48 first hours after skin closure)
- Pain at rest(4, 8, 12, 16, 20, 24, 36, 48 and 78 hours after skin closure, entrance and exit from the recovery room)
- 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)
- Health staff workload(For the 48 first hours after skin closure)
- Wound infections(the first 10 days after skin closure)
- Local anaesthetic systemic toxicity(During the first 48 hours after skin closure)
- Discomfort due to material(At catheter retrieval)
- Comfort with Breast Feeding(For the the 48 first hours after skin closure)
- All cause morbidity(For the first 10 days after skin closure)