Efficacy of Opioid-free Anesthesia in Reducing Postoperative Pain in Chronic Pain Patients Undergoing Spinal Surgery
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 chronic-pain
Started Aug 2016
Longer than P75 for phase_3 chronic-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2016
CompletedFirst Posted
Study publicly available on registry
April 27, 2016
CompletedStudy Start
First participant enrolled
August 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedMarch 26, 2020
March 1, 2020
4.1 years
March 29, 2016
March 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quantified opioid-consumption
48 hours following surgery
Secondary Outcomes (3)
Visual analogue scale (VAS) pain scores
48 hours following surgery
Time of stay in post-anesthetic care unit (PACU)
up to 5 hours following surgery
Incidence of adverse events
48 hours following surgery
Study Arms (2)
Opioid-free anesthetic (OFA) group
EXPERIMENTALTraditional Anesthesia (TA) group
ACTIVE COMPARATORInterventions
An opioid-free general anesthetic technique utilizing dexmedetomidine, ketamine, and lidocaine infusions
Traditional general anesthetic technique utilizing sufentanil, fentanyl or remifentanil
Eligibility Criteria
You may qualify if:
- Chronic pain \> 6 months, opiate-using patients scheduled for thoracic or lumbar spinal surgery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ben Limlead
Study Sites (1)
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ben Lim, MD
University of Saskatchewan
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Anesthesiologist
Study Record Dates
First Submitted
March 29, 2016
First Posted
April 27, 2016
Study Start
August 2, 2016
Primary Completion
September 1, 2020
Study Completion
September 1, 2020
Last Updated
March 26, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share