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

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

Conditions

• Orthopedic Trauma Surgery Patients
• Postoperative Pain
• Opioid Use
• Depression
• Post-traumatic Stress Disorder (PTSD)

Interventions

DRUG

Ketamine

Participants in this group will receive a single intravenous (IV) dose of ketamine at 0.5 mg/kg, administered within 30 minutes of anesthesia induction during surgical fixation for musculoskeletal trauma. The purpose of the intervention is to evaluate ketamine's effect on postoperative pain, opioid consumption, and psychological recovery, including symptoms of depression and post-traumatic stress disorder (PTSD).

DRUG

standard general anesthesia

Participants in this group will receive standard general anesthesia during surgical fixation for musculoskeletal trauma. No ketamine will be administered. This group serves as a comparison to evaluate the effects of ketamine on pain, opioid use, and psychological recovery.

Sponsors & Collaborators

• Texas Tech University Health Sciences Center

  lead OTHER

Principal Investigators

• Max Evan Davis, MD · Texas Tech University Health Sciences Center Department of Orthopaedic Surgery,

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-11-06

Primary Completion

2027-05-31

Completion

2028-05-31

FDA Drug

Yes

Countries

• United States

Study Locations