Continuous Wound Infusion in Lumbar or Thoracic Surgery

Grenoble Alpes University Hospital Center (CHU)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Lumbar Spine Surgery; Thoracic Spine Surgery

Treatments: Drug: Saline solution 0.9%; Drug: Ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01743794

1008

Details and patient eligibility

About

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".

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

ropivacaine 0.2%, wound infusion

Experimental group

Treatment:

Drug: Ropivacaine

saline solution 0.9%, wound infusion

Placebo Comparator group

Treatment:

Drug: Saline solution 0.9%