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

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Ropivacaine
Morphine
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Postoperative pain, Postoperative morphine consumption, Emergency cesarean delivery, Ropivacaine, Local anesthetic wound 48-hours infusion, Emergency cesarean section

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Hôpital Couple Enfant - CHU de Grenoble

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Continuous wound infusion group

Epidural morphine group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pain score during mobilization
Visual analog scale for pain while the patient moves from lying to sitting

Secondary Outcome Measures

Pain score at rest
Visual analog scale for pain while the patient is at rest
Pain score during mobilization
Visual analog scale for pain while the patient moves from lying to sitting
The incidence of morphine side effects: nausea, vomiting, pruritus
At every time points, side effects will be recorded
Duration of Indwelling Urethral Catheters
At ever time points, the presence of urethral catheter will be recorded and total duration will be compared.
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.
Morphine consumption dose
Total dose of morphine consumed for pain management after the epidural bolus
Parturient satisfaction score
Satisfaction about pain management and breastfeeding
Complications during wound-catheter removal
Fever, pain, difficulties and infection at removal
Delay between birth and breastfeeding
Duration of stay
Residual pain
Numeric Rating Scale for Pain by phone interview

Full Information

First Posted
April 1, 2015
Last Updated
November 7, 2022
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT02410317
Brief Title
Ropivacaine Through Continuous Infusion Versus Epidural Morphine for Postoperative Analgesia After Emergency Cesarean Section
Acronym
ROMANCE
Official Title
Ropivacaine Through Continuous Infusion Versus Epidural Morphine for Postoperative Analgesia After Emergency Cesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 2015 (Actual)
Primary Completion Date
August 28, 2021 (Actual)
Study Completion Date
December 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Postoperative pain, Postoperative morphine consumption, Emergency cesarean delivery, Ropivacaine, Local anesthetic wound 48-hours infusion, Emergency cesarean section

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continuous wound infusion group
Arm Type
Experimental
Arm Description
Patients receive analgesia through a multiorifice wound catheter connected to ropivacaine infusion. Saline solution is given in the epidural bolus.
Arm Title
Epidural morphine group
Arm Type
Active Comparator
Arm Description
Patients receive epidural analgesia through an epidural bolus of morphine. Saline solution is perfused through the wound catheter.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Type
Drug
Intervention Name(s)
Morphine
Primary Outcome Measure Information:
Title
Pain score during mobilization
Description
Visual analog scale for pain while the patient moves from lying to sitting
Time Frame
at 24 hours
Secondary Outcome Measure Information:
Title
Pain score at rest
Description
Visual analog scale for pain while the patient is at rest
Time Frame
at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h)
Title
Pain score during mobilization
Description
Visual analog scale for pain while the patient moves from lying to sitting
Time Frame
at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h)
Title
The incidence of morphine side effects: nausea, vomiting, pruritus
Description
At every time points, side effects will be recorded
Time Frame
at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h)
Title
Duration of Indwelling Urethral Catheters
Description
At ever time points, the presence of urethral catheter will be recorded and total duration will be compared.
Time Frame
at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h)
Title
Recovery of bowel function
Description
At ever time points, patients will be asked whether they recovered bowel function and total duration to recover bowel function will be compared.
Time Frame
at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h)
Title
Morphine consumption dose
Description
Total dose of morphine consumed for pain management after the epidural bolus
Time Frame
During hospital stay (an average of 3 days)
Title
Parturient satisfaction score
Description
Satisfaction about pain management and breastfeeding
Time Frame
at 48 hours
Title
Complications during wound-catheter removal
Description
Fever, pain, difficulties and infection at removal
Time Frame
at 48 hours
Title
Delay between birth and breastfeeding
Time Frame
During hospital stay (an average of 3 days)
Title
Duration of stay
Time Frame
Hospital stay (an average of 3 days)
Title
Residual pain
Description
Numeric Rating Scale for Pain by phone interview
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Hôpital Couple Enfant - CHU de Grenoble
City
Grenoble
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
2208533
Citation
Fuller JG, McMorland GH, Douglas MJ, Palmer L. Epidural morphine for analgesia after caesarean section: a report of 4880 patients. Can J Anaesth. 1990 Sep;37(6):636-40. doi: 10.1007/BF03006481.
Results Reference
background
PubMed Identifier
10735794
Citation
Palmer CM, Nogami WM, Van Maren G, Alves DM. Postcesarean epidural morphine: a dose-response study. Anesth Analg. 2000 Apr;90(4):887-91. doi: 10.1097/00000539-200004000-00021.
Results Reference
background
PubMed Identifier
19588413
Citation
Bamigboye AA, Hofmeyr GJ. Local anaesthetic wound infiltration and abdominal nerves block during caesarean section for postoperative pain relief. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD006954. doi: 10.1002/14651858.CD006954.pub2.
Results Reference
background
PubMed Identifier
8717568
Citation
Mecklem DW, Humphrey MD, Hicks RW. Efficacy of bupivacaine delivered by wound catheter for post-Caesarean section analgesia. Aust N Z J Obstet Gynaecol. 1995 Nov;35(4):416-21. doi: 10.1111/j.1479-828x.1995.tb02156.x.
Results Reference
background
PubMed Identifier
16798442
Citation
Ranta PO, Ala-Kokko TI, Kukkonen JE, Ohtonen PP, Raudaskoski TH, Reponen PK, Rawal N. Incisional and epidural analgesia after caesarean delivery: a prospective, placebo-controlled, randomised clinical study. Int J Obstet Anesth. 2006 Jul;15(3):189-94. doi: 10.1016/j.ijoa.2006.02.003.
Results Reference
background
PubMed Identifier
22025490
Citation
O'Neill P, Duarte F, Ribeiro I, Centeno MJ, Moreira J. Ropivacaine continuous wound infusion versus epidural morphine for postoperative analgesia after cesarean delivery: a randomized controlled trial. Anesth Analg. 2012 Jan;114(1):179-85. doi: 10.1213/ANE.0b013e3182368e87. Epub 2011 Oct 24.
Results Reference
background
PubMed Identifier
11464348
Citation
Siddik SM, Aouad MT, Jalbout MI, Rizk LB, Kamar GH, Baraka AS. Diclofenac and/or propacetamol for postoperative pain management after cesarean delivery in patients receiving patient controlled analgesia morphine. Reg Anesth Pain Med. 2001 Jul-Aug;26(4):310-5. doi: 10.1053/rapm.2001.21828.
Results Reference
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PubMed Identifier
20859153
Citation
Rackelboom T, Strat SL, Silvera S, Schmitz T, Bassot A, Goffinet F, Ozier Y, Beaussier M, Mignon A. Improving continuous wound infusion effectiveness for postoperative analgesia after cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2010 Oct;116(4):893-900. doi: 10.1097/AOG.0b013e3181f38ac6.
Results Reference
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Ropivacaine Through Continuous Infusion Versus Epidural Morphine for Postoperative Analgesia After Emergency Cesarean Section

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