Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

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. 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
Information provided by (Responsible Party):
Ben Lim, University of Saskatchewan

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.

Condition or disease Intervention/treatment Phase
Chronic Pain Anesthesia Drug: Opioid-free general anesthetic Drug: Traditional general anesthetic Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Opioid-free Anesthesia in Reducing Postoperative Pain in Chronic Pain Patients Undergoing Spinal Surgery: A Pilot Study
Actual Study Start Date : August 2, 2016
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Opioid-free anesthetic (OFA) group Drug: Opioid-free general anesthetic
An opioid-free general anesthetic technique utilizing dexmedetomidine, ketamine, and lidocaine infusions

Active Comparator: Traditional Anesthesia (TA) group Drug: Traditional general anesthetic
Traditional general anesthetic technique utilizing sufentanil, fentanyl or remifentanil

Primary Outcome Measures :
  1. Quantified opioid-consumption [ Time Frame: 48 hours following surgery ]

Secondary Outcome Measures :
  1. Visual analogue scale (VAS) pain scores [ Time Frame: 48 hours following surgery ]
  2. Time of stay in post-anesthetic care unit (PACU) [ Time Frame: up to 5 hours following surgery ]
  3. Incidence of adverse events [ Time Frame: 48 hours following surgery ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT02752477

Layout table for location information
Canada, Saskatchewan
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
Ben Lim
Layout table for investigator information
Principal Investigator: Ben Lim, MD University of Saskatchewan
Layout table for additonal information
Responsible Party: Ben Lim, Anesthesiologist, University of Saskatchewan Identifier: NCT02752477    
Other Study ID Numbers: BIO15-253
First Posted: April 27, 2016    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ben Lim, University of Saskatchewan:
Additional relevant MeSH terms:
Layout table for MeSH terms
Chronic Pain
Pain, Postoperative
Neurologic Manifestations
Postoperative Complications
Pathologic Processes
Anesthetics, General
Central Nervous System Depressants
Physiological Effects of Drugs