Back to resultsEfficacy of Opioid-free Anesthesia in Reducing Postoperative Pain in Chronic Pain Patients Undergoing Spinal Surgery
Primary Purpose
Chronic Pain, Anesthesia
Status
Unknown status
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Opioid-free general anesthetic
Traditional general anesthetic
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring Opioid-sparing
Eligibility Criteria
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
Sites / Locations
- Royal University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Opioid-free anesthetic (OFA) group
Traditional Anesthesia (TA) group
Arm Description
Outcomes
Primary Outcome Measures
Quantified opioid-consumption
Secondary Outcome Measures
Visual analogue scale (VAS) pain scores
Time of stay in post-anesthetic care unit (PACU)
Incidence of adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02752477
Brief Title
Efficacy of Opioid-free Anesthesia in Reducing Postoperative Pain in Chronic Pain Patients Undergoing Spinal Surgery
Official Title
Efficacy of Opioid-free Anesthesia in Reducing Postoperative Pain in Chronic Pain Patients Undergoing Spinal Surgery: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 2, 2016 (Actual)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ben Lim
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Anesthesia
Keywords
Opioid-sparing
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Opioid-free anesthetic (OFA) group
Arm Type
Experimental
Arm Title
Traditional Anesthesia (TA) group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Opioid-free general anesthetic
Intervention Description
An opioid-free general anesthetic technique utilizing dexmedetomidine, ketamine, and lidocaine infusions
Intervention Type
Drug
Intervention Name(s)
Traditional general anesthetic
Intervention Description
Traditional general anesthetic technique utilizing sufentanil, fentanyl or remifentanil
Primary Outcome Measure Information:
Title
Quantified opioid-consumption
Time Frame
48 hours following surgery
Secondary Outcome Measure Information:
Title
Visual analogue scale (VAS) pain scores
Time Frame
48 hours following surgery
Title
Time of stay in post-anesthetic care unit (PACU)
Time Frame
up to 5 hours following surgery
Title
Incidence of adverse events
Time Frame
48 hours following surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ben Lim, MD
Organizational Affiliation
University of Saskatchewan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Opioid-free Anesthesia in Reducing Postoperative Pain in Chronic Pain Patients Undergoing Spinal Surgery
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