Clinical trial NCT01743794: Continuous Wound Infusion in Lumbar or Thoracic Surgery
Official title: Efficacy of Continuous Wound Infusion in Major Lumbar and Thoracic Spine Surgery : A Randomised, Double-blinded, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Lumbar Spine Surgery
Thoracic Spine Surgery
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2012-12-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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".


Eligibility criteria: 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

Primary outcomes:
measure: morphine consumption
timeFrame: 48 hours after surgery
Secondary outcomes:
measure: number of patients in need of morphine in post surgery monitoring room
timeFrame: 1 hour after surgery
measure: morphine consumption in post surgery monitoring room
timeFrame: 1 hour post surgery
measure: consumption of morphine
timeFrame: 72 hours after surgery
measure: global self appreciation of pain management
timeFrame: at 72 hours
measure: Time required for post surgery functional recovery
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
measure: Adverse effects of morphine
timeFrame: 72 hours after surgery
measure: hospitalization delay
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
measure: asked bolus divided by delivered bolus
timeFrame: until 72 hours after surgery
measure: Score for pain intensity
timeFrame: until 72 hours after surgery
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital, Departement of Anesthesia and Intensive Care
state: Rhone Alpes
Study officials:
References:
citation: Greze J, Vighetti A, Incagnoli P, Quesada JL, Albaladejo P, Palombi O, Tonetti J, Bosson JL, Payen JF. Does continuous wound infiltration enhance baseline intravenous multimodal analgesia after posterior spinal fusion surgery? A randomized, double-blinded, placebo-controlled study. Eur Spine J. 2017 Mar;26(3):832-839. doi: 10.1007/s00586-016-4428-1. Epub 2016 Feb 10.