NCT06066879

Pre-Operative Ketamine Infusion for Post Operative Pain Control After Revision Spinal Surgery

Non Randomized Cohort Study to Evaluate Pre-operative Ketamine Infusion for the Decrease Overall Pain Levels Following Revision Cervical or Lumbar Fusion Surgery Through the Post-operative Phase, Decreasing Reliance on Opioids for Daily Pain Control, Opioid Related Adverse Events, as Well as Improving Mood, Functionality, and Quality of Life for Patients That Live With Chronic Pain Syndromes.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: AXIS Spine Center- a division of Northwest Specialty Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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 medications as well as increased use during the immediate post-operative phase. Ketamine infusion peri-operatively has been shown to decrease post-operative pain from invasive surgeries, such as cervical and lumbar fusions, and there is also evidence that ketamine infusions in general can help to improve levels of chronic pain with less need for opioid medications. Our study asks if pre-operative ketamine infusion will decrease overall pain levels following cervical or lumbar surgery through the post-operative phase, decreasing reliance on opioids for daily pain control, as well as improving mood, functionality, and quality of life for patients that live with chronic pain syndromes. Ketamine, an N-methyl-D-aspartate receptor antagonist, has newly received attention for its ability to provide anesthesia in patients with chronic pain syndromes and neuropathic pain syndromes. Recent studies have shown evidence that intra-operative delivery of ketamine can reduce acute post-operative analgesic consumption in patients following a variety of surgical procedures, though this is often focused on the acute post-operative period (initial 72 hours). Additionally, studies have shown that ketamine infusions in patients with chronic pain requiring opioid analgesics does provide some variable level of baseline pain improvement. For patients with chronic neck or back pain, choosing to undergo invasive spinal surgeries potentially could provide some relief of their daily pain, though there is a chance that they will still require daily narcotics for pain relief post-operatively.

Conditions

• Revision Spine Surgery
• Fusion of Spine
• Cervical Fusion
• Lumbar Fusion

Interventions

Type	Name	Description
DRUG	Ketamine Hydrochloride	Pre-Operative Ketamine infusion

Timeline

• Start date: 2023-09-18
• Primary completion: 2024-09-01
• Completion: 2024-12-01
• First posted: 2023-10-04
• Last updated: 2023-10-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study