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

NCT02410317 | Completed Phase 3 DMC

• 1 other identifier: Eudract 2014-002044-41
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

Postoperative pain; Postoperative morphine consumption; Emergency cesarean delivery; Ropivacaine; Local anesthetic wound 48-hours infusion; Emergency cesarean section

Outcome Measures

Primary Outcomes (1)

• Pain score during mobilization

  Visual analog scale for pain while the patient moves from lying to sitting

  at 24 hours

Secondary Outcomes (11)

• Pain score at rest

  at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h)

• Pain score during mobilization

  at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h)

• The incidence of morphine side effects: nausea, vomiting, pruritus

  at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h)

• Duration of Indwelling Urethral Catheters

  at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h)

• Recovery of bowel function

  at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h)

Study Arms (2)

Continuous wound infusion group

EXPERIMENTAL

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

Drug: Ropivacaine

Epidural morphine group

ACTIVE COMPARATOR

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

Drug: Morphine

Interventions

Ropivacaine DRUG

Continuous wound infusion group

Morphine DRUG

Epidural morphine group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Hôpital Couple Enfant - CHU de Grenoble

Grenoble, France

Location

Related Publications (8)

• 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.

  PMID: 2208533 BACKGROUND

• 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.

  PMID: 10735794 BACKGROUND

• 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.

  PMID: 19588413 BACKGROUND

• 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.

  PMID: 8717568 BACKGROUND

• 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.

  PMID: 16798442 BACKGROUND

• 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.

  PMID: 22025490 BACKGROUND

• 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.

  PMID: 11464348 BACKGROUND

• 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.

  PMID: 20859153 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine; Morphine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2015
• First Posted: April 7, 2015
• Study Start: February 1, 2015
• Primary Completion: August 28, 2021
• Study Completion: December 28, 2021
• Last Updated: November 8, 2022

Record last verified: 2021-09

Locations

FR (1)