CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 101 enrolled
Drug / intervention
Ropivacaine +1 moredrug
Likely dose
Not stated in record
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Search/NCT02410317
NCT02410317Phase 3Completed

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

University Hospital, Grenoble·interventional·Posted Apr 7, 2015·Updated Nov 8, 2022

In Brief

A Phase 3 clinical trial evaluating Ropivacaine and Morphine for Postoperative Pain. Completed, enrolled 101 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 7, 2015
Enrollment StartFeb 1, 2015
Primary CompletionAug 28, 2021
Study CompletionDec 28, 2021
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 11.2 years ago

Interventions

Ropivacainedrug

Morphinedrug