Continuous Wound Infusion in Lumbar or Thoracic Surgery
Efficacy of Continuous Wound Infusion in Major Lumbar and Thoracic Spine Surgery : A Randomised, Double-blinded, Placebo-controlled Study
Introduction : Spine surgery is responsible for intense postoperative pain that can be treated by an analgesia multimodal approach (IV analgesic infusion and local anesthesia). Continuous wound infiltration is an efficient and simple technique with few adverse effects yet very few studies have investigated its potential use in spine surgery. Our randomised, controlled, double-blinded trial aims to evaluate efficacy of continuous wound infiltration after major spine surgery.
Methods : After written consent is obtained, the surgeon inserts, at the end of surgery, a multiholes catheter under muscular layers. Patients are randomised in two groups : The "treated group" receives ropivacaine 0.2% infusion (bolus of 10 milliliters (mL) followed by 8 mL/h continuous infusion during 48 hours) and the "control group" receives saline solution (0.9%). In addition, all patients receive patient-controlled intra-venous morphine analgesia. The investigators hypothesize that the "treated group" will consume morphine less than the "control group".
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
- Fase 3
Contacten en locaties
Studie Locaties
-
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Rhone Alpes
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Grenoble, Rhone Alpes, Frankrijk, 38000
- University Hospital, Departement of Anesthesia and Intensive Care
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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:
- adults
- > 18 years
- Physical status score I, II or III (American Society of Anesthesiologists)
- lumbar or thoracic spine surgery with arthrodesis through posterior only approach
- signed informed consent
- beneficiary of social security
Exclusion Criteria:
- vulnerable persons according to law
- scoliosis surgery
- local anesthetic allergia
- contraindication to ketamine, acetaminophene, nefopam, non steroidal anti inflammatory, ropivacaine, morphine, droperidol
- long term anti platelet aggregants
- inability to comply to protocol requirements
- psychiatric disorders or cognitive disabilities
- chronic pain or long term opioids consumption
- diabetes
- obesity (BMI > 30)
- pregnancy or lactation
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: ropivacaine 0.2%, wound infusion
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wound infusion, 0.2%, bolus 10mL followed by 8 mL/h infusion
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Placebo-vergelijker: saline solution 0.9%, wound infusion
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wound infusion, 0.9%, bolus 10mL followed by 8 mL/h
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
morphine consumption
Tijdsspanne: 48 hours after surgery
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48 hours after surgery
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
number of patients in need of morphine in post surgery monitoring room
Tijdsspanne: 1 hour after surgery
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1 hour after surgery
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morphine consumption in post surgery monitoring room
Tijdsspanne: 1 hour post surgery
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1 hour post surgery
|
|
consumption of morphine
Tijdsspanne: 72 hours after surgery
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72 hours after surgery
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|
global self appreciation of pain management
Tijdsspanne: at 72 hours
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at 72 hours
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Time required for post surgery functional recovery
Tijdsspanne: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
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participants will be followed for the duration of hospital stay, an expected average of 3 weeks
|
|
Adverse effects of morphine
Tijdsspanne: 72 hours after surgery
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72 hours after surgery
|
|
hospitalization delay
Tijdsspanne: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
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participants will be followed for the duration of hospital stay, an expected average of 3 weeks
|
|
asked bolus divided by delivered bolus
Tijdsspanne: until 72 hours after surgery
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until 72 hours after surgery
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Score for pain intensity
Tijdsspanne: until 72 hours after surgery
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until 72 hours after surgery
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Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
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 (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 1008
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