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

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

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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