Status:
UNKNOWN
Pre-Operative Ketamine Infusion for Post Operative Pain Control After Revision Spinal Surgery
Lead Sponsor:
AXIS Spine Center- a division of Northwest Specialty Hospital
Collaborating Sponsors:
IDAHO PANHANDLE HEALTH DISTRICT
Conditions:
Revision Spine Surgery
Fusion of Spine
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
To determine if a pre-operative ketamine infusion would provide a similar decrease in post-operative analgesic and opioid consumption as intra-operative ketamine, but expand the monitoring period thro...
Detailed Description
Patients with chronic pain requiring daily opioid use for pain control turn to invasive surgeries for long-term management of their pain, though there is still a chance of requiring opioid pain medica...
Eligibility Criteria
Inclusion
- Male or female, aged 18-75
- Able to understand the informed consent form and provide written informed consent and able to complete outcome measures
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Daily opiate use totaling ≥50 morphine milli-equivalents (MME) or more for 6 weeks or greater
- Scheduled for revision surgical fusion of the cervical or lumbar spine
- Total duration of neck or back pain \>12 weeks
Exclusion
- Current use of Ketamine for any other medical conditions
- Uncontrolled hypertension
- Uncontrolled Diabetes
- Increased intracranial pressure
- Pregnancy or lactation
- Known allergic reactions to components of ketamine or midazolam
- Participants who ultimately require intra-operative ketamine administration for anesthesia
- Treatment with another investigational drug or other intervention within 12 months of study treatment
- History of psychosis or schizophrenia
- History of conversion disorder
- History of clotting disease
- Pending or active compensation claim, litigation or disability remuneration (secondary gain)
- Surgically naïve patients
- Allergies to any of the medications to be used during the procedures
- Active infection or systemic or localized infection at needle entry sites (subject may be considered for inclusion once infection is resolved)
- Uncontrolled immunosuppression (e.g. AIDS, cancer)
- Participating in another clinical trial/investigation within 30 days prior to signing informed consent
- Subject unwilling or unable to comply with follow up schedule or protocol requirements
Key Trial Info
Start Date :
September 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06066879
Start Date
September 18 2023
End Date
December 1 2024
Last Update
October 4 2023
Active Locations (1)
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1
AXIS Spine
Coeur d'Alene, Idaho, United States, 83815