Ropivacaine Through Continuous Infusion Versus Epidural Morphine for Postoperative Analgesia After Emergency Cesarean Section
- Registration Number
- NCT02410317
- Lead Sponsor
- University Hospital, Grenoble
- Brief Summary
The cesarean section is one of the most commonly performed surgeries in the world and it represents 20% of the births in France. Postoperative pain is moderate-to-severe during the first 48 hours after this procedure. Thereby its control is prominent for the medical team in order to shorten the duration of hospital stay as well as to permit an early return to daily activities for these surgical patients.
Pain control after cesarean section is usually based on non-opioids and epidural administration of morphine if an epidural catheter has been previously placed for the procedure. However epidural morphine is associated with a number of side effects. Wound infiltration with local anesthetics has been widely used in the multimodal management of postoperative pain and it may reduce postoperative morphine consumption.
In patients enrolled for emergency cesarean delivery with epidural catheter, the objective of this study will be to compare the analgesia provided by a local anesthetic wound 48-hours infusion through a multiorifice catheter (ropivacaine 2 mg/mL) versus epidural analgesia (epidural morphine bolus). Quality of pain control will be assessed with the measurements of morphine consumption and pain scores at rest and during mobilisation over 48 hours. At 3 months, patients will be interviewed to assess their residual pain and their satisfaction.
It is hypothesized that local anesthetic wound infusion would be non-inferior than epidural morphine analgesia to control pain after cesarean section, and be associated with a reduction of side effects related to the analgesics.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 101
- Minimum age 18 years
- ASA-1 and 2 Parturient
- Emergency Cesarean delivery under epidural anesthesia
- Suprapubic incision used for cesarean section
- Functional epidural Catheter before the cesarean decision
(ASA Scores : Physical Status score)
- ASA-3 and 4 Parturient
- BMI > 35 (before pregnancy)
- Existing chronic pain
- Contra-indication to study treatments
- Chronic use of analgesics or morphinic
- Preeclampsia
- Infection
- < 37 weeks pregnant +/- 3 days
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Epidural morphine group Morphine Patients receive epidural analgesia through an epidural bolus of morphine. Saline solution is perfused through the wound catheter. Continuous wound infusion group Ropivacaine Patients receive analgesia through a multiorifice wound catheter connected to ropivacaine infusion. Saline solution is given in the epidural bolus.
- Primary Outcome Measures
Name Time Method Pain score during mobilization at 24 hours Visual analog scale for pain while the patient moves from lying to sitting
- Secondary Outcome Measures
Name Time Method Pain score at rest at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h) Visual analog scale for pain while the patient is at rest
Parturient satisfaction score at 48 hours Satisfaction about pain management and breastfeeding
Delay between birth and breastfeeding During hospital stay (an average of 3 days) Duration of stay Hospital stay (an average of 3 days) Complications during wound-catheter removal at 48 hours Fever, pain, difficulties and infection at removal
Pain score during mobilization at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h) Visual analog scale for pain while the patient moves from lying to sitting
The incidence of morphine side effects: nausea, vomiting, pruritus at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h) At every time points, side effects will be recorded
Duration of Indwelling Urethral Catheters at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h) At ever time points, the presence of urethral catheter will be recorded and total duration will be compared.
Recovery of bowel function at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h) At ever time points, patients will be asked whether they recovered bowel function and total duration to recover bowel function will be compared.
Morphine consumption dose During hospital stay (an average of 3 days) Total dose of morphine consumed for pain management after the epidural bolus
Residual pain 3 months Numeric Rating Scale for Pain by phone interview
Trial Locations
- Locations (1)
Hôpital Couple Enfant - CHU de Grenoble
🇫🇷Grenoble, France