Ropivacaine Through Continuous Infusion Versus Epidural Morphine for Postoperative Analgesia After Emergency Cesarean Section

Study Overview
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Brief Summary
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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.

Official Title
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Ropivacaine Through Continuous Infusion Versus Epidural Morphine for Postoperative Analgesia After Emergency Cesarean Section

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Ropivacaine
* Drug: Morphine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous wound infusion group<br>Patients receive analgesia through a multiorifice wound catheter connected to ropivacaine infusion. Saline solution is given in the epidural bolus. | Drug: Ropivacaine<br> <br> |
| Active Comparator: Epidural morphine group<br>Patients receive epidural analgesia through an epidural bolus of morphine. Saline solution is perfused through the wound catheter. | Drug: Morphine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score during mobilization | Visual analog scale for pain while the patient moves from lying to sitting | at 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score at rest | Visual analog scale for pain while the patient is at rest | at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h) | 
| Pain score during mobilization | Visual analog scale for pain while the patient moves from lying to sitting | at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h) | 
| The incidence of morphine side effects: nausea, vomiting, pruritus | At every time points, side effects will be recorded | at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h) | 
| Duration of Indwelling Urethral Catheters | At ever time points, the presence of urethral catheter will be recorded and total duration will be compared. | at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h) | 
| Recovery of bowel function | At ever time points, patients will be asked whether they recovered bowel function and total duration to recover bowel function will be compared. | at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h) | 
| Morphine consumption dose | Total dose of morphine consumed for pain management after the epidural bolus | During hospital stay (an average of 3 days) | 
| Parturient satisfaction score | Satisfaction about pain management and breastfeeding | at 48 hours | 
| Complications during wound-catheter removal | Fever, pain, difficulties and infection at removal | at 48 hours | 
| 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 | Numeric Rating Scale for Pain by phone interview | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative pain, Postoperative morphine consumption, Emergency cesarean delivery, Ropivacaine, Local anesthetic wound 48-hours infusion, Emergency cesarean section