Ketamine for Pain, Opioid Use, and Mental Health in Orthopedic Trauma Patients

Phase 4

Not yet recruiting

• Conditions: Orthopedic Trauma Surgery Patients; Postoperative Pain; Opioid Use; Post-traumatic Stress Disorder (PTSD); Depression
• Interventions: Drug: Ketamine; Drug: standard general anesthesia

• Registration Number: NCT06903819
• Lead Sponsor: Texas Tech University Health Sciences Center

Brief Summary

The goal of this clinical trial is to learn if ketamine, given during surgery, can help improve recovery for adults with serious orthopedic trauma. The study will test whether ketamine reduces pain, lowers the need for opioids, and improves mental health outcomes like depression and post-traumatic stress disorder (PTSD).

The main questions it aims to answer are:

Does ketamine reduce pain after surgery compared to standard anesthesia?

Does ketamine reduce the amount of opioids patients need for pain control?

Does ketamine improve symptoms of depression and PTSD after orthopedic trauma?

Researchers will compare patients who receive ketamine during surgery with those who receive standard anesthesia without ketamine to see if ketamine helps improve both physical and psychological recovery.

Participants will:

Be randomly assigned to receive either a single dose of ketamine or standard anesthesia during surgery.

Report their pain using a simple pain scale (Visual Analog Scale, VAS).

Complete short surveys about mood and mental health (PHQ-9 for depression and PCL-5 for PTSD) at several time points after surgery.

Allow the research team to review their electronic medical records to measure opioid prescriptions during recovery.

Attend follow-up visits in clinic or by secure telehealth (e.g., Zoom) at 1-7 days, 2-3 weeks, 6 weeks, 3 months, and 6 months after surgery

Detailed Description

Orthopedic trauma patients often face challenges in both physical and psychological recovery following injury. Pain control is difficult, as effective pain relief must be balanced against the risks of opioid dependence. In addition, rates of depression and post-traumatic stress disorder (PTSD) are high in this population, further complicating recovery. These overlapping challenges highlight the need for new approaches that address both pain and mental health outcomes.

Ketamine, a commonly used anesthetic, has properties that may benefit trauma patients beyond its routine role in surgery. Evidence suggests that low-dose intravenous (IV) ketamine can reduce acute postoperative pain, decrease the need for opioid medications, and have rapid effects on depressive symptoms. Some studies also indicate that ketamine may reduce PTSD-related symptoms by influencing brain pathways involved in stress and memory. However, despite these promising effects, ketamine has not been fully integrated into trauma care protocols, in part due to limited large-scale data in orthopedic populations.

This single-blind randomized controlled trial is designed to evaluate whether a single intraoperative dose of IV ketamine (0.5 mg/kg) improves recovery in adults undergoing surgical fixation for musculoskeletal trauma. Participants will be randomly assigned to receive either ketamine or standard anesthesia without ketamine. While the anesthesia team will be aware of group assignment to ensure patient safety, participants and postoperative care teams will remain blinded.

The study will measure multiple aspects of recovery, including:

Postoperative pain intensity, using a validated Visual Analog Scale (VAS).

Opioid consumption during recovery, quantified from electronic medical records and converted to morphine milligram equivalents (MME).

Psychological outcomes, including symptoms of depression and PTSD, assessed with the PHQ-9 and PCL-5 surveys at defined follow-up intervals.

Follow-up assessments will occur at several time points after surgery, ranging from the early postoperative period (1-7 days) to longer-term recovery (up to 6 months). To accommodate patients unable to attend in-person visits, telehealth-based follow-up is available.

By focusing on both physical and psychological outcomes, this trial aims to determine whether ketamine can serve as a dual-purpose intervention in orthopedic trauma care. Results will provide evidence on the feasibility and potential benefits of incorporating ketamine into standard surgical practice for patients with severe musculoskeletal injuries.

Study Timeline

• Study First Submitted: 2025-03-25
• Study First Submitted QC: 2025-03-25
• Study First Posted: 2025-04-01
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-16
• Last Update Posted: 2025-09-22
• Study Start: 2025-10-15
• Primary Completion: 2027-05
• Study Completion: 2028-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Adults aged 18-65
• Undergoing acute operative fixation for musculoskeletal trauma
• Injury Severity Score (ISS) greater than 15
• Ability to provide informed consent (or consent provided by a legally authorized representative)

Exclusion Criteria

• Age under 18 or over 65
• Use of ketamine for preoperative or postoperative sedation
• Known allergy or contraindication to ketamine
• Prior unsuccessful ketamine therapy for major depressive disorder (MDD) or PTSD
• Severe psychiatric conditions or psychotic features
• History of dementia or glaucoma
• Currently engaged in trauma-focused cognitive behavioral therapy or PTSD psychotherapy started within the past 3 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamine Group	Ketamine	Participants in this group will receive a single intraoperative dose of intravenous (IV) ketamine (0.5 mg/kg) within 30 minutes of anesthesia induction. The intervention is designed to assess ketamine's effects on postoperative pain, opioid use, and symptoms of depression and PTSD in patients undergoing surgical fixation for musculoskeletal trauma.
Control Group	standard general anesthesia	Participants in this group will receive standard general anesthesia without ketamine. This group serves as a comparison to evaluate the effectiveness of ketamine on postoperative pain levels, opioid consumption, and psychological recovery following orthopedic trauma surgery.

Primary Outcome Measures

Name	Time	Method
Pain Intensity (VAS)	1-7 days, 2-3 weeks (±1 week), 6 weeks (±2 weeks), 3 months (±3 weeks), and 6 months (±5 weeks) postoperatively.	Pain intensity will be assessed using the Visual Analog Scale (VAS), a validated 0-100 continuous scale (or 0-10 categorical equivalent). Higher scores indicate greater pain. This outcome evaluates whether intraoperative ketamine reduces postoperative pain compared to standard anesthesia.

Secondary Outcome Measures

Name	Time	Method
Postoperative Opioid Consumption (MME)	1-7 days, 2-3 weeks (±1 week), 6 weeks (±2 weeks), 3 months (±3 weeks), and 6 months (±5 weeks) postoperatively.	Opioid use will be quantified from prescription records in the electronic medical record (EMR) and converted into morphine milligram equivalents (MME). This will assess whether intraoperative ketamine reduces opioid requirements compared to the control group.

Trial Locations

Locations (2)

Texas Tech University Health Sciences Center Lubbock; 🇺🇸 Lubbock, Texas, United States

University Medical Center; 🇺🇸 Lubbock, Texas, United States