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

B

Ben Lim

Status and phase

Unknown
Phase 3

Conditions

Chronic Pain
Anesthesia

Treatments

Drug: Traditional general anesthetic
Drug: Opioid-free general anesthetic

Study type

Interventional

Funder types

Other

Identifiers

NCT02752477
BIO15-253

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 2 patient groups

Opioid-free anesthetic (OFA) group
Experimental group
Treatment:
Drug: Opioid-free general anesthetic
Traditional Anesthesia (TA) group
Active Comparator group
Treatment:
Drug: Traditional general anesthetic

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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