Anesthesia, Local, Breast Feeding, Postoperative Pain
Conditions
Keywords
Postcesarean Section, Postoperative Pain, Care, Postoperative, Anesthesia, Local, Breast Feeding, Morphine, Pain Measurement, levobupivacaine
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.
Interventions
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).
Sponsors
Poissy-Saint Germain Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative morphine consumption | 24 first hours after cesarean section | Quantity of morphine injected by the patient controlled analgesia pump |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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. |
| Local anaesthetic systemic toxicity | During the first 48 hours after skin closure | Every adverse effect attributed to local anaesthetic by an skilled anesthesiologist |
Countries
France
Outcome results
None listed