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

Postoperative Pain Clinical Trial

— ROMANCE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02410317
• Other study ID #: Eudract 2014-002044-41
• Status: Completed
• Phase: Phase 3
• Start date: February 2015
• Est. completion date: December 28, 2021

Study information

• Verified date: September 2021
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: December 28, 2021
• Est. primary completion date: August 28, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Ropivacaine

• Morphine

Locations

Country	Name	City	State
France	Hôpital Couple Enfant - CHU de Grenoble	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (8)

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. Review. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score during mobilization	Visual analog scale for pain while the patient moves from lying to sitting	at 24 hours
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Morphine consumption dose	Total dose of morphine consumed for pain management after the epidural bolus	During hospital stay (an average of 3 days)
Secondary	Parturient satisfaction score	Satisfaction about pain management and breastfeeding	at 48 hours
Secondary	Complications during wound-catheter removal	Fever, pain, difficulties and infection at removal	at 48 hours
Secondary	Delay between birth and breastfeeding		During hospital stay (an average of 3 days)
Secondary	Duration of stay		Hospital stay (an average of 3 days)
Secondary	Residual pain	Numeric Rating Scale for Pain by phone interview	3 months