- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02410317
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 3
Kontakter och platser
Studieorter
-
-
-
Grenoble, Frankrike
- Hôpital Couple Enfant - CHU de Grenoble
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Continuous wound infusion group
Patients receive analgesia through a multiorifice wound catheter connected to ropivacaine infusion.
Saline solution is given in the epidural bolus.
|
|
Aktiv komparator: Epidural morphine group
Patients receive epidural analgesia through an epidural bolus of morphine.
Saline solution is perfused through the wound catheter.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Pain score during mobilization
Tidsram: at 24 hours
|
Visual analog scale for pain while the patient moves from lying to sitting
|
at 24 hours
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Pain score at rest
Tidsram: at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h)
|
Visual analog scale for pain while the patient is at rest
|
at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h)
|
Pain score during mobilization
Tidsram: 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
|
at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h)
|
The incidence of morphine side effects: nausea, vomiting, pruritus
Tidsram: at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h)
|
At every time points, side effects will be recorded
|
at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h)
|
Duration of Indwelling Urethral Catheters
Tidsram: 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.
|
at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h)
|
Recovery of bowel function
Tidsram: 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.
|
at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h)
|
Morphine consumption dose
Tidsram: During hospital stay (an average of 3 days)
|
Total dose of morphine consumed for pain management after the epidural bolus
|
During hospital stay (an average of 3 days)
|
Parturient satisfaction score
Tidsram: at 48 hours
|
Satisfaction about pain management and breastfeeding
|
at 48 hours
|
Complications during wound-catheter removal
Tidsram: at 48 hours
|
Fever, pain, difficulties and infection at removal
|
at 48 hours
|
Delay between birth and breastfeeding
Tidsram: During hospital stay (an average of 3 days)
|
During hospital stay (an average of 3 days)
|
|
Duration of stay
Tidsram: Hospital stay (an average of 3 days)
|
Hospital stay (an average of 3 days)
|
|
Residual pain
Tidsram: 3 months
|
Numeric Rating Scale for Pain by phone interview
|
3 months
|
Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Patologiska processer
- Postoperativa komplikationer
- Smärta
- Neurologiska manifestationer
- Sjukdomsegenskaper
- Smärta, postoperativt
- Nödsituationer
- Läkemedels fysiologiska effekter
- Depressiva medel i centrala nervsystemet
- Agenter från det perifera nervsystemet
- Analgetika
- Sensoriska systemagenter
- Bedövningsmedel
- Analgetika, Opioid
- Narkotika
- Anestesimedel, lokal
- Ropivakain
- Morfin
Andra studie-ID-nummer
- Eudract 2014-002044-41
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Postoperativ smärta
-
Örebro University, SwedenAvslutadPostoperativ smärtintensitet | Rescue Pain KravSverige
-
Korea University Anam HospitalKorea UniversityAvslutadSmärtmätning | Visual Analog Pain Scale
-
Alanya Alaaddin Keykubat UniversityAvslutadSterilisering, Tubal | Visual Analog Pain Scale
-
Turkish Ministry of Health, Kahramanmaras Provincial...RekryteringVisual Analog Pain ScaleKalkon
-
Ankara UniversityAvslutadSmärtmätning | Visual Analog Pain ScaleKalkon
-
East Carolina UniversityIndragen
-
University Hospital, GrenobleAvslutadDövhet | Visual Analog Pain ScaleFrankrike
-
Moens MaartenRekryteringMisslyckad Ryggkirurgi Syndrom | Persistent Spinal Pain Syndrome Typ 2Belgien
-
Moens MaartenVrije Universiteit BrusselRekryteringRyggmärgsstimulering | Persistent Spinal Pain Syndrome Typ 2Belgien
-
Wake Forest University Health SciencesRekryteringPhantom Limb Pain (PLP)Förenta staterna
Kliniska prövningar på Morfin
-
Istanbul UniversityAvslutad
-
University of LuebeckAvslutadAkut hjärtinfarktTyskland