The purpose of this study is to determine wether wound infiltration brings additional analgesia effect after cesarean section with optimal standard postoperative analgesia
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
68
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).
Poissy Saint Germain en Laye Hospital
Poissy, France
Postoperative morphine consumption
Quantity of morphine injected by the patient controlled analgesia pump
Time frame: 24 first hours after cesarean section
Pain at mobilization
Numerical pain scale during mobilization
Time frame: 4, 8, 12, 16, 20, 24, 36, 48 and 78 hours after skin closure, entrance and exit from the recovery room
Early walking
Time taken for early walking
Time frame: in the 72 first hours after skin closure
Resumption of gastrointestinal function
Interval from the end of surgery until the first gas from the intestinal tract
Time frame: First 72 hours after skin closure
Treatment tolerance
Nausea, vomiting, pruritus, excessive sedation
Time frame: First 72 hours after skin closure
Maternal satisfaction
Analogic numerical scale on a specific form
Time frame: 2 days after skin closure
Health staff workload
Number of intervention for nursing, breastfeeding help, and cesarean wound dressing change
Time frame: For the 48 first hours after skin closure
Wound infections
Number of wound infection needing specific cares appeared during the observation time
Time frame: the first 10 days after skin closure
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Local anaesthetic systemic toxicity
Every adverse effect attributed to local anaesthetic by an skilled anesthesiologist
Time frame: During the first 48 hours after skin closure
Discomfort due to material
Discomfort caused by the material and pain at retrieval of the catheter, assessed by an analogic scale on a specific form
Time frame: At catheter retrieval
Technical problems related to the catheter
Premature withdrawal or occlusion of the catheter
Time frame: During the 48 first hours after skin closure
Pain at rest
Numerical pain scale at rest
Time frame: 4, 8, 12, 16, 20, 24, 36, 48 and 78 hours after skin closure, entrance and exit from the recovery room
Comfort with Breast Feeding
Analogic numerical scale on a specific form
Time frame: For the the 48 first hours after skin closure
All cause morbidity
Postpartum hemorrhage or every adverse event occurred during the observation period.
Time frame: For the first 10 days after skin closure