Efficacy of Opioid-free Anesthesia in Reducing Postoperative Pain in Chronic Pain Patients Undergoing Spinal Surgery
Phase 3
- Conditions
- AnesthesiaChronic Pain
- Interventions
- Drug: Opioid-free general anestheticDrug: Traditional general anesthetic
- Registration Number
- NCT02752477
- Lead Sponsor
- Ben Lim
- 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 available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Opioid-free anesthetic (OFA) group Opioid-free general anesthetic - Traditional Anesthesia (TA) group Traditional general anesthetic -
- Primary Outcome Measures
Name Time Method Quantified opioid-consumption 48 hours following surgery
- Secondary Outcome Measures
Name Time Method Time of stay in post-anesthetic care unit (PACU) up to 5 hours following surgery Visual analogue scale (VAS) pain scores 48 hours following surgery Incidence of adverse events 48 hours following surgery
Trial Locations
- Locations (1)
Royal University Hospital
🇨🇦Saskatoon, Saskatchewan, Canada