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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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 3
Contacten en locaties
Studie Locaties
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Grenoble, Frankrijk
- Hôpital Couple Enfant - CHU de Grenoble
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Continuous wound infusion group
Patients receive analgesia through a multiorifice wound catheter connected to ropivacaine infusion.
Saline solution is given in the epidural bolus.
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Actieve vergelijker: Epidural morphine group
Patients receive epidural analgesia through an epidural bolus of morphine.
Saline solution is perfused through the wound catheter.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Pain score during mobilization
Tijdsspanne: at 24 hours
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Visual analog scale for pain while the patient moves from lying to sitting
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at 24 hours
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Pain score at rest
Tijdsspanne: at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h)
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Visual analog scale for pain while the patient is at rest
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at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h)
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Pain score during mobilization
Tijdsspanne: at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h)
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Visual analog scale for pain while the patient moves from lying to sitting
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at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h)
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The incidence of morphine side effects: nausea, vomiting, pruritus
Tijdsspanne: at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h)
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At every time points, side effects will be recorded
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at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h)
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Duration of Indwelling Urethral Catheters
Tijdsspanne: at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h)
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At ever time points, the presence of urethral catheter will be recorded and total duration will be compared.
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at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h)
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Recovery of bowel function
Tijdsspanne: at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h)
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At ever time points, patients will be asked whether they recovered bowel function and total duration to recover bowel function will be compared.
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at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h)
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Morphine consumption dose
Tijdsspanne: During hospital stay (an average of 3 days)
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Total dose of morphine consumed for pain management after the epidural bolus
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During hospital stay (an average of 3 days)
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Parturient satisfaction score
Tijdsspanne: at 48 hours
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Satisfaction about pain management and breastfeeding
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at 48 hours
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Complications during wound-catheter removal
Tijdsspanne: at 48 hours
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Fever, pain, difficulties and infection at removal
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at 48 hours
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Delay between birth and breastfeeding
Tijdsspanne: During hospital stay (an average of 3 days)
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During hospital stay (an average of 3 days)
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Duration of stay
Tijdsspanne: Hospital stay (an average of 3 days)
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Hospital stay (an average of 3 days)
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Residual pain
Tijdsspanne: 3 months
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Numeric Rating Scale for Pain by phone interview
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3 months
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Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Algemene publicaties
- 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.
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Pathologische processen
- Postoperatieve complicaties
- Pijn
- Neurologische manifestaties
- Ziekte attributen
- Pijn, postoperatief
- Spoedgevallen
- Fysiologische effecten van medicijnen
- Depressiva van het centrale zenuwstelsel
- Agenten van het perifere zenuwstelsel
- Pijnstillers
- Sensorische systeemagenten
- Anesthesie
- Pijnstillers, opioïden
- Verdovende middelen
- Anesthesie, lokaal
- Ropivacaine
- Morfine
Andere studie-ID-nummers
- Eudract 2014-002044-41
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