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

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 Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Morphine; Drug: Ropivacaine

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Grenoble, France
    • Hôpital Couple Enfant - CHU de Grenoble

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): August 28, 2021
• Study Completion (Actual): December 28, 2021

Study Registration Dates

• First Submitted: April 1, 2015
• First Submitted That Met QC Criteria: April 6, 2015
• First Posted (Estimate): April 7, 2015

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Postoperative pain; Ropivacaine; Postoperative morphine consumption; Emergency cesarean delivery; Local anesthetic wound 48-hours infusion; Emergency cesarean section
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Disease Attributes; Pain, Postoperative; Emergencies; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Opioid; Narcotics; Anesthetics, Local; Ropivacaine; Morphine
• Other Study ID Numbers: Eudract 2014-002044-41