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Efficacy of Opioid-free Anesthesia in Reducing Postoperative Pain in Chronic Pain Patients Undergoing Spinal 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.
 
ClinicalTrials.gov Identifier: NCT02752477
Recruitment Status : Unknown
Verified March 2020 by Ben Lim, University of Saskatchewan.
Recruitment status was:  Active, not recruiting
First Posted : April 27, 2016
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
Ben Lim, University of Saskatchewan

Tracking Information
First Submitted Date  ICMJE March 29, 2016
First Posted Date  ICMJE April 27, 2016
Last Update Posted Date March 26, 2020
Actual Study Start Date  ICMJE August 2, 2016
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2016)
Quantified opioid-consumption [ Time Frame: 48 hours following surgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2016)
  • Visual analogue scale (VAS) pain scores [ Time Frame: 48 hours following surgery ]
  • Time of stay in post-anesthetic care unit (PACU) [ Time Frame: up to 5 hours following surgery ]
  • Incidence of adverse events [ Time Frame: 48 hours following surgery ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Opioid-free Anesthesia in Reducing Postoperative Pain in Chronic Pain Patients Undergoing Spinal Surgery
Official Title  ICMJE Efficacy of Opioid-free Anesthesia in Reducing Postoperative Pain in Chronic Pain Patients Undergoing Spinal Surgery: A Pilot Study
Brief Summary The objective of this trial is to determine whether an opioid-free general anesthetic (OFA) technique utilizing ketamine, dexmedetomidine, and lidocaine infusions can help reduce postoperative pain in opiate-dependent chronic pain patients (CPPs) undergoing spine surgery when compared with traditional opioid-containing techniques. It is expected that this OFA regimen will have a measurable reduction on postoperative opioid consumption and pain scores in CPPs.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Pain
  • Anesthesia
Intervention  ICMJE
  • Drug: Opioid-free general anesthetic
    An opioid-free general anesthetic technique utilizing dexmedetomidine, ketamine, and lidocaine infusions
  • Drug: Traditional general anesthetic
    Traditional general anesthetic technique utilizing sufentanil, fentanyl or remifentanil
Study Arms  ICMJE
  • Experimental: Opioid-free anesthetic (OFA) group
    Intervention: Drug: Opioid-free general anesthetic
  • Active Comparator: Traditional Anesthesia (TA) group
    Intervention: Drug: Traditional general anesthetic
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 23, 2016)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Chronic pain > 6 months, opiate-using patients scheduled for thoracic or lumbar spinal surgery

Exclusion Criteria:

  • Pregnant or breastfeeding women, significant hepatic, renal or cardiac disease, allergy to any of the study drugs, inability to consent, respond to pain assessments or use the patient controlled analgesia device
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02752477
Other Study ID Numbers  ICMJE BIO15-253
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ben Lim, University of Saskatchewan
Study Sponsor  ICMJE Ben Lim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ben Lim, MD University of Saskatchewan
PRS Account University of Saskatchewan
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP