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

Grenoble Alpes University Hospital Center (CHU)

Status and phase: Completed; Phase 3

Conditions: Postoperative Pain

Treatments: Drug: Morphine; Drug: Ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02410317

Eudract 2014-002044-41

Details and patient eligibility

About

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.

Enrollment: 101 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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101 participants in 2 patient groups

Continuous wound infusion group

Experimental group

Description:

Patients receive analgesia through a multiorifice wound catheter connected to ropivacaine infusion. Saline solution is given in the epidural bolus.

Treatment:

Drug: Ropivacaine

Epidural morphine group

Active Comparator group

Description:

Patients receive epidural analgesia through an epidural bolus of morphine. Saline solution is perfused through the wound catheter.

Treatment:

Drug: Morphine