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

NCT ID: NCT02752477

Last Updated: 2020-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-02

Study Completion Date

2020-09-30

Brief Summary

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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

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Conditions

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Chronic Pain Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Opioid-free anesthetic (OFA) group

Group Type EXPERIMENTAL

Opioid-free general anesthetic

Intervention Type DRUG

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

Traditional Anesthesia (TA) group

Group Type ACTIVE_COMPARATOR

Traditional general anesthetic

Intervention Type DRUG

Traditional general anesthetic technique utilizing sufentanil, fentanyl or remifentanil

Interventions

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Opioid-free general anesthetic

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

Intervention Type DRUG

Traditional general anesthetic

Traditional general anesthetic technique utilizing sufentanil, fentanyl or remifentanil

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ben Lim

OTHER

Sponsor Role lead

Responsible Party

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Ben Lim

Anesthesiologist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ben Lim, MD

Role: PRINCIPAL_INVESTIGATOR

University of Saskatchewan

Locations

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Royal University Hospital

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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Canada

Other Identifiers

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BIO15-253

Identifier Type: -

Identifier Source: org_study_id

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