NCT06066879

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 through the post-operative phase up to 90 days. Hypothesis is that pre-operative ketamine infusion will lead to a decrease in narcotic consumption from baseline following an elective cervical or lumbar fusion, leading to increased functionality and quality of life for these patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 18, 2023

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 4, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

October 4, 2023

Status Verified

September 1, 2023

Enrollment Period

12 months

First QC Date

September 28, 2023

Last Update Submit

September 28, 2023

Conditions

Revision Spine SurgeryFusion of SpineCervical FusionLumbar Fusion

Keywords

ketaminerevision surgeryopioid

Outcome Measures

Primary Outcomes (1)

  • Degree of reduction in opiate consumption following surgery

    12 weeks

Secondary Outcomes (1)

  • Responder rate

    12 weeks

Study Arms (2)

Ketamine Infusion

EXPERIMENTAL

ketamine infusion at 0.5 mg/kg over one hour two weeks (14 days) prior to their scheduled surgical date

Drug: Ketamine Hydrochloride

Standard Of Care

NO INTERVENTION

No use of ketamine pre, intra, or post-operatively

Interventions

Ketamine HydrochlorideDRUG

Pre-Operative Ketamine infusion

Ketamine Infusion

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Uncontrolled immunosuppression (e.g. AIDS, cancer)
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AXIS Spine

Coeur d'Alene, Idaho, 83815, United States

RECRUITING

MeSH Terms

Conditions

Klippel-Feil Syndrome

Interventions

Ketamine

Condition Hierarchy (Ancestors)

DysostosesBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Jessica Jameson, MD

    division of NSWH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisa Maples, BS

CONTACT

2086640290elisa.maples@nwsh.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2023

First Posted

October 4, 2023

Study Start

September 18, 2023

Primary Completion

September 1, 2024

Study Completion

December 1, 2024

Last Updated

October 4, 2023

Record last verified: 2023-09

Locations

US(1)