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Continuous Wound Infusion in Lumbar or Thoracic Surgery

Sponsor
University Hospital, Grenoble (Other)
Overall Status
Completed
CT.gov ID
NCT01743794
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
18
Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2/Phase 3

Study Design

Study Type:
Interventional
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 :
Jan 1, 2011
Actual Primary Completion Date :
Jan 1, 2011
Actual Study Completion Date :
Jul 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. morphine consumption [48 hours after surgery]

Secondary Outcome Measures

  1. number of patients in need of morphine in post surgery monitoring room [1 hour after surgery]

  2. morphine consumption in post surgery monitoring room [1 hour post surgery]

  3. consumption of morphine [72 hours after surgery]

  4. global self appreciation of pain management [at 72 hours]

  5. Time required for post surgery functional recovery [participants will be followed for the duration of hospital stay, an expected average of 3 weeks]

  6. Adverse effects of morphine [72 hours after surgery]

  7. hospitalization delay [participants will be followed for the duration of hospital stay, an expected average of 3 weeks]

  8. asked bolus divided by delivered bolus [until 72 hours after surgery]

  9. Score for pain intensity [until 72 hours after surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital, Departement of Anesthesia and Intensive Care Grenoble Rhone Alpes France 38000

Sponsors and Collaborators

  • University Hospital, Grenoble

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01743794
Other Study ID Numbers:
  • 1008
First Posted:
Dec 6, 2012
Last Update Posted:
Dec 6, 2012
Last Verified:
Dec 1, 2012
Additional relevant MeSH terms:
Aneurysm, Dissecting
Ropivacaine

Study Results

No Results Posted as of Dec 6, 2012