Lumbar Spine Surgery, Thoracic Spine Surgery
Conditions
Brief summary
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.
Interventions
DRUGRopivacaine
wound infusion, 0.2%, bolus 10mL followed by 8 mL/h infusion
wound infusion, 0.9%, bolus 10mL followed by 8 mL/h
Sponsors
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| morphine consumption | 48 hours after surgery |
Secondary
| Measure | Time frame |
|---|---|
| morphine consumption in post surgery monitoring room | 1 hour post surgery |
| consumption of morphine | 72 hours after surgery |
| global self appreciation of pain management | at 72 hours |
| Time required for post surgery functional recovery | participants will be followed for the duration of hospital stay, an expected average of 3 weeks |
| number of patients in need of morphine in post surgery monitoring room | 1 hour after surgery |
| hospitalization delay | participants will be followed for the duration of hospital stay, an expected average of 3 weeks |
| asked bolus divided by delivered bolus | until 72 hours after surgery |
| Score for pain intensity | until 72 hours after surgery |
| Adverse effects of morphine | 72 hours after surgery |
Countries
France
Outcome results
None listed