Postoperative Pain
Conditions
Keywords
Postoperative pain, Postoperative morphine consumption, Emergency cesarean delivery, Ropivacaine, Local anesthetic wound 48-hours infusion, Emergency cesarean section
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.
Interventions
DRUGRopivacaine
DRUGMorphine
Sponsors
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain score during mobilization | at 24 hours | Visual analog scale for pain while the patient moves from lying to sitting |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Complications during wound-catheter removal | at 48 hours | Fever, pain, difficulties and infection at removal |
| Delay between birth and breastfeeding | During hospital stay (an average of 3 days) | — |
| Duration of stay | Hospital stay (an average of 3 days) | — |
| Residual pain | 3 months | Numeric Rating Scale for Pain by phone interview |
| Parturient satisfaction score | at 48 hours | Satisfaction about pain management and breastfeeding |
Countries
France
Outcome results
None listed