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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Pain; Anesthesia
• Intervention / Treatment: Drug: Opioid-free general anesthetic; Drug: Traditional general anesthetic

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 0W8
      • Royal University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Opioid-free anesthetic (OFA) group	Drug: Opioid-free general anesthetic; An opioid-free general anesthetic technique utilizing dexmedetomidine, ketamine, and lidocaine infusions
ACTIVE_COMPARATOR: Traditional Anesthesia (TA) group	Drug: Traditional general anesthetic; Traditional general anesthetic technique utilizing sufentanil, fentanyl or remifentanil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Quantified opioid-consumption	48 hours following surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Ben Lim
• Investigators: Principal Investigator: Ben Lim, MD, University of Saskatchewan

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 2, 2016
• Primary Completion (ANTICIPATED): September 1, 2020
• Study Completion (ANTICIPATED): September 1, 2020

Study Registration Dates

• First Submitted: March 29, 2016
• First Submitted That Met QC Criteria: April 23, 2016
• First Posted (ESTIMATE): April 27, 2016

Study Record Updates

• Last Update Posted (ACTUAL): March 26, 2020
• Last Update Submitted That Met QC Criteria: March 24, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Opioid-sparing
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Chronic Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics; Anesthetics, General
• Other Study ID Numbers: BIO15-253

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO