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".
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
- Fas 3
Kontakter och platser
Studieorter
-
-
Rhone Alpes
-
Grenoble, Rhone Alpes, Frankrike, 38000
- University Hospital, Departement of Anesthesia and Intensive Care
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: ropivacaine 0.2%, wound infusion
|
wound infusion, 0.2%, bolus 10mL followed by 8 mL/h infusion
|
|
Placebo-jämförare: saline solution 0.9%, wound infusion
|
wound infusion, 0.9%, bolus 10mL followed by 8 mL/h
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
morphine consumption
Tidsram: 48 hours after surgery
|
48 hours after surgery
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
number of patients in need of morphine in post surgery monitoring room
Tidsram: 1 hour after surgery
|
1 hour after surgery
|
|
morphine consumption in post surgery monitoring room
Tidsram: 1 hour post surgery
|
1 hour post surgery
|
|
consumption of morphine
Tidsram: 72 hours after surgery
|
72 hours after surgery
|
|
global self appreciation of pain management
Tidsram: at 72 hours
|
at 72 hours
|
|
Time required for post surgery functional recovery
Tidsram: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
|
participants will be followed for the duration of hospital stay, an expected average of 3 weeks
|
|
Adverse effects of morphine
Tidsram: 72 hours after surgery
|
72 hours after surgery
|
|
hospitalization delay
Tidsram: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
|
participants will be followed for the duration of hospital stay, an expected average of 3 weeks
|
|
asked bolus divided by delivered bolus
Tidsram: until 72 hours after surgery
|
until 72 hours after surgery
|
|
Score for pain intensity
Tidsram: until 72 hours after surgery
|
until 72 hours after surgery
|
Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1008
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