Lumbar Spine Surgery Clinical Trial
Official title:
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".
Status | Completed |
Enrollment | 60 |
Est. completion date | July 2012 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | University Hospital, Departement of Anesthesia and Intensive Care | Grenoble | Rhone Alpes |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Grenoble |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | morphine consumption | 48 hours after surgery | No | |
Secondary | number of patients in need of morphine in post surgery monitoring room | 1 hour after surgery | No | |
Secondary | morphine consumption in post surgery monitoring room | 1 hour post surgery | No | |
Secondary | consumption of morphine | 72 hours after surgery | No | |
Secondary | global self appreciation of pain management | at 72 hours | No | |
Secondary | Time required for post surgery functional recovery | participants will be followed for the duration of hospital stay, an expected average of 3 weeks | No | |
Secondary | Adverse effects of morphine | 72 hours after surgery | Yes | |
Secondary | hospitalization delay | participants will be followed for the duration of hospital stay, an expected average of 3 weeks | No | |
Secondary | asked bolus divided by delivered bolus | until 72 hours after surgery | No | |
Secondary | Score for pain intensity | until 72 hours after surgery | No |
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