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Continuous Wound Infusion in Lumbar or Thoracic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01743794
Recruitment Status : Completed
First Posted : December 6, 2012
Last Update Posted : December 6, 2012
Information provided by (Responsible Party):
University Hospital, Grenoble

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".

Condition or disease Intervention/treatment Phase
Lumbar Spine Surgery Thoracic Spine Surgery Drug: Ropivacaine Drug: Saline solution 0.9% Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Continuous Wound Infusion in Major Lumbar and Thoracic Spine Surgery : A Randomised, Double-blinded, Placebo-controlled Study
Study Start Date : January 2011
Actual Primary Completion Date : January 2011
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: ropivacaine 0.2%, wound infusion Drug: Ropivacaine
wound infusion, 0.2%, bolus 10mL followed by 8 mL/h infusion

Placebo Comparator: saline solution 0.9%, wound infusion Drug: Saline solution 0.9%
wound infusion, 0.9%, bolus 10mL followed by 8 mL/h

Primary Outcome Measures :
  1. morphine consumption [ Time Frame: 48 hours after surgery ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01743794

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University Hospital, Departement of Anesthesia and Intensive Care
Grenoble, Rhone Alpes, France, 38000
Sponsors and Collaborators
University Hospital, Grenoble
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University Hospital, Grenoble Identifier: NCT01743794    
Other Study ID Numbers: 1008
First Posted: December 6, 2012    Key Record Dates
Last Update Posted: December 6, 2012
Last Verified: December 2012
Additional relevant MeSH terms:
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Aneurysm, Dissecting
Vascular Diseases
Cardiovascular Diseases
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents