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

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ClinicalTrials.gov Identifier: NCT02752477
Recruitment Status : Unknown
Verified March 2020 by Ben Lim, University of Saskatchewan.
Recruitment status was:  Active, not recruiting
First Posted : April 27, 2016
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
Ben Lim, University of Saskatchewan

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Pain Anesthesia Drug: Opioid-free general anesthetic Drug: Traditional general anesthetic Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Opioid-free Anesthesia in Reducing Postoperative Pain in Chronic Pain Patients Undergoing Spinal Surgery: A Pilot Study
Actual Study Start Date : August 2, 2016
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Quantified opioid-consumption [ Time Frame: 48 hours following surgery ]

Secondary Outcome Measures :
  1. Visual analogue scale (VAS) pain scores [ Time Frame: 48 hours following surgery ]
  2. Time of stay in post-anesthetic care unit (PACU) [ Time Frame: up to 5 hours following surgery ]
  3. Incidence of adverse events [ Time Frame: 48 hours following surgery ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02752477


Locations
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Canada, Saskatchewan
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
Ben Lim
Investigators
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Principal Investigator: Ben Lim, MD University of Saskatchewan
More Information
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Responsible Party: Ben Lim, Anesthesiologist, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT02752477    
Other Study ID Numbers: BIO15-253
First Posted: April 27, 2016    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ben Lim, University of Saskatchewan:
Opioid-sparing
Additional relevant MeSH terms:
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Chronic Pain
Pain, Postoperative
Pain
Neurologic Manifestations
Postoperative Complications
 Pathologic Processes
Anesthetics
Anesthetics, General
Central Nervous System Depressants
Physiological Effects of Drugs