Continuous Wound Infusion in Lumbar or Thoracic Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01743794
First received: May 9, 2012
Last updated: December 5, 2012
Last verified: December 2012
  Purpose

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 Intervention Phase
Lumbar Spine Surgery
Thoracic Spine Surgery
Drug: Ropivacaine
Drug: Saline solution 0.9%
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • morphine consumption [ Time Frame: 48 hours after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • number of patients in need of morphine in post surgery monitoring room [ Time Frame: 1 hour after surgery ] [ Designated as safety issue: No ]
  • morphine consumption in post surgery monitoring room [ Time Frame: 1 hour post surgery ] [ Designated as safety issue: No ]
  • consumption of morphine [ Time Frame: 72 hours after surgery ] [ Designated as safety issue: No ]
  • global self appreciation of pain management [ Time Frame: at 72 hours ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Adverse effects of morphine [ Time Frame: 72 hours after surgery ] [ Designated as safety issue: Yes ]
  • hospitalization delay [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks ] [ Designated as safety issue: No ]
  • asked bolus divided by delivered bolus [ Time Frame: until 72 hours after surgery ] [ Designated as safety issue: No ]
  • Score for pain intensity [ Time Frame: until 72 hours after surgery ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: January 2011
Study Completion Date: July 2012
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01743794

Locations
France
University Hospital, Departement of Anesthesia and Intensive Care
Grenoble, Rhone Alpes, France, 38000
Sponsors and Collaborators
University Hospital, Grenoble
  More Information

No publications provided

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01743794     History of Changes
Other Study ID Numbers: 1008
Study First Received: May 9, 2012
Last Updated: December 5, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014