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Completed

NCT Number: NCT01743794

Continuous Wound Infusion in Lumbar or Thoracic Surgery

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".

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Key information

Conditions

Lumbar Spine Surgery Thoracic Spine Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University Hospital, Departement of Anesthesia and Intensive Care

Grenoble, Auvergne-Rhône-Alpes, 38000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine

Drug

wound infusion, 0.2%, bolus 10mL followed by 8 mL/h infusion

Saline solution 0.9%

Drug

wound infusion, 0.9%, bolus 10mL followed by 8 mL/h

Primary outcomes

  1. morphine consumption

    Time frame: 48 hours after surgery

Secondary outcomes

  1. number of patients in need of morphine in post surgery monitoring room

    Time frame: 1 hour after surgery

  2. morphine consumption in post surgery monitoring room

    Time frame: 1 hour post surgery

  3. consumption of morphine

    Time frame: 72 hours after surgery

  4. global self appreciation of pain management

    Time frame: at 72 hours

  5. Time required for post surgery functional recovery

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks

  6. Adverse effects of morphine

    Time frame: 72 hours after surgery

  7. hospitalization delay

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks

  8. asked bolus divided by delivered bolus

    Time frame: until 72 hours after surgery

  9. Score for pain intensity

    Time frame: until 72 hours after surgery

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

Efficacy of Continuous Wound Infusion in Major Lumbar and Thoracic Spine Surgery : A Randomised, Double-blinded, Placebo-controlled Study

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Dec 6, 2012
Registry last updated
Dec 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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