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

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ClinicalTrials.gov Identifier: NCT02410317
Recruitment Status : Recruiting
First Posted : April 7, 2015
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Ropivacaine Drug: Morphine Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Ropivacaine Through Continuous Infusion Versus Epidural Morphine for Postoperative Analgesia After Emergency Cesarean Section
Actual Study Start Date : February 2015
Estimated Primary Completion Date : May 25, 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Pain score during mobilization [ Time Frame: at 24 hours ]
    Visual analog scale for pain while the patient moves from lying to sitting


Secondary Outcome Measures :
  1. Pain score at rest [ Time Frame: at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h) ]
    Visual analog scale for pain while the patient is at rest

  2. Pain score during mobilization [ Time Frame: 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

  3. The incidence of morphine side effects: nausea, vomiting, pruritus [ Time Frame: at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h) ]
    At every time points, side effects will be recorded

  4. Duration of Indwelling Urethral Catheters [ Time Frame: 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.

  5. Recovery of bowel function [ Time Frame: 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.

  6. Morphine consumption dose [ Time Frame: During hospital stay (an average of 3 days) ]
    Total dose of morphine consumed for pain management after the epidural bolus

  7. Parturient satisfaction score [ Time Frame: at 48 hours ]
    Satisfaction about pain management and breastfeeding

  8. Complications during wound-catheter removal [ Time Frame: at 48 hours ]
    Fever, pain, difficulties and infection at removal

  9. Delay between birth and breastfeeding [ Time Frame: During hospital stay (an average of 3 days) ]
  10. Duration of stay [ Time Frame: Hospital stay (an average of 3 days) ]
  11. Residual pain [ Time Frame: 3 months ]
    Numeric Rating Scale for Pain by phone interview



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02410317


Contacts
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Contact: Jean-François PAYEN, MD 04 76 76 92 88 JFPayen@chu-grenoble.fr

Locations
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France
Hôpital Couple Enfant - CHU de Grenoble Recruiting
Grenoble, France
Contact: Jean-François PAYEN, MD         
Contact: Sabine BERGERET, MD         
Principal Investigator: Jean-François PAYEN, MD         
Sub-Investigator: Sabine BERGERET, MD         
Sub-Investigator: Dominique RICHE, MD         
Sub-Investigator: Ana ROGE, MD         
Sub-Investigator: Edith RAMAIN, MD         
Sponsors and Collaborators
University Hospital, Grenoble
Publications:

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02410317    
Other Study ID Numbers: Eudract 2014-002044-41
First Posted: April 7, 2015    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Keywords provided by University Hospital, Grenoble:
Postoperative pain
Postoperative morphine consumption
Emergency cesarean delivery
Ropivacaine
Local anesthetic wound 48-hours infusion
Emergency cesarean section
Additional relevant MeSH terms:
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Emergencies
Pain, Postoperative
Disease Attributes
Pathologic Processes
Postoperative Complications
Pain
Neurologic Manifestations
Signs and Symptoms
Morphine
Ropivacaine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Local
Anesthetics