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Completed

NCT Number: NCT02410317

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Hôpital Couple Enfant - CHU de Grenoble

Grenoble, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine

Drug

Morphine

Drug

Primary outcomes

  1. Pain score during mobilization

    Time frame: at 24 hours

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: ROMANCE

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Apr 7, 2015
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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