Efficacy of Opioid-free Anesthesia in Reducing Postoperative Pain in Chronic Pain Patients Undergoing Spinal Surgery: A Pilot Study

Ben Lim1 site in 1 country30 target enrollmentAugust 2, 2016

ConditionsChronic Pain Anesthesia

InterventionsOpioid-free general anesthetic Traditional general anesthetic

DrugsOpioid-free general anesthetic Traditional general anesthetic

Overview

Phase: Phase 3
Intervention: Opioid-free general anesthetic
Conditions: Chronic Pain
Sponsor: Ben Lim
Enrollment: 30
Locations: 1
Primary Endpoint: Quantified opioid-consumption
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2, 2016

End Date

September 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ben Lim

Responsible Party

Sponsor Investigator

Principal Investigator

Ben Lim

Anesthesiologist

University of Saskatchewan

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

Arms & Interventions

Opioid-free anesthetic (OFA) group

Intervention: Opioid-free general anesthetic

Traditional Anesthesia (TA) group

Intervention: Traditional general anesthetic

Outcomes

Primary Outcomes

Quantified opioid-consumption

Time Frame: 48 hours following surgery

Secondary Outcomes

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)