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Postoperative PainPhase 3ROMANCENCT02410317

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

A Phase 3 study testing Ropivacaine and Morphine in people with Postoperative Pain, run by University Hospital, Grenoble at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Postoperative Pain
What is being tested?
Ropivacaine and Morphine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
101 participants
Where
1 siteFrance
Study dates
Feb 2015to 28 Dec 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hôpital Couple Enfant - CHU de Grenoble

    Grenoble

Other trials in France

About this study

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.

Read more

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.

Being tested
Ropivacaine, Morphine
Keywords
Postoperative pain, Postoperative morphine consumption, Emergency cesarean delivery, Ropivacaine, Local anesthetic wound 48-hours infusion, Emergency cesarean section
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02410317
Study groupRoleWhat they receive
Continuous wound infusion groupExperimentalPatients receive analgesia through a multiorifice wound catheter connected to ropivacaine infusion. Saline solution is given in the epidural bolus.
Receives: Drug: Ropivacaine
Epidural morphine groupActive comparatorPatients receive epidural analgesia through an epidural bolus of morphine. Saline solution is perfused through the wound catheter.
Receives: Drug: Morphine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain score during mobilization

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

    Measured: at 24 hours

Secondary outcomes (11)

  1. Pain score at rest

    Visual analog scale for pain while the patient is at rest

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

  2. Pain score during mobilization

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

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

  3. The incidence of morphine side effects: nausea, vomiting, pruritus

    At every time points, side effects will be recorded

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

  4. Duration of Indwelling Urethral Catheters

    At ever time points, the presence of urethral catheter will be recorded and total duration will be compared.

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

  5. 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.

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

  6. Morphine consumption dose

    Total dose of morphine consumed for pain management after the epidural bolus

    Measured: During hospital stay (an average of 3 days)

  7. Parturient satisfaction score

    Satisfaction about pain management and breastfeeding

    Measured: at 48 hours

  8. Complications during wound-catheter removal

    Fever, pain, difficulties and infection at removal

    Measured: at 48 hours

  9. Delay between birth and breastfeeding

    Measured: During hospital stay (an average of 3 days)

  10. Duration of stay

    Measured: Hospital stay (an average of 3 days)

  11. Residual pain

    Numeric Rating Scale for Pain by phone interview

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completion28 Aug 2021
  4. Study completion28 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02410317
Sponsor's protocol ID
Eudract 2014-002044-41
Acronym
ROMANCE
Status last verified
Sep 2021
First submitted
1 Apr 2015
Last updated
8 Nov 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 2208533

  • 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.

    PubMed 10735794

  • 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;2009(3):CD006954. doi: 10.1002/14651858.CD006954.pub2.

    PubMed 19588413

  • 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.

    PubMed 8717568

  • 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.

    PubMed 16798442

  • 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.

    PubMed 22025490

  • 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.

    PubMed 11464348

  • 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.

    PubMed 20859153

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ropivacaine and Morphine in people with Postoperative Pain, run by University Hospital, Grenoble at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain score during mobilization (time frame: at 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02410317, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.

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