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Efficacy of Opioid-free Anesthesia in Reducing Postoperative Pain in Chronic Pain Patients Undergoing Spinal Surgery

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02752477
Enrollment
30
Registered
2016-04-27
Start date
2016-08-02
Completion date
2020-09-30
Last updated
2020-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Chronic Pain

Keywords

Opioid-sparing

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.

Interventions

DRUGOpioid-free general anesthetic

An opioid-free general anesthetic technique utilizing dexmedetomidine, ketamine, and lidocaine infusions

DRUGTraditional general anesthetic

Traditional general anesthetic technique utilizing sufentanil, fentanyl or remifentanil

Sponsors

Ben Lim
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Quantified opioid-consumption48 hours following surgery

Secondary

MeasureTime frame
Visual analogue scale (VAS) pain scores48 hours following surgery
Time of stay in post-anesthetic care unit (PACU)up to 5 hours following surgery
Incidence of adverse events48 hours following surgery

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026