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

NCT06903819 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: IRB-FY2025-75
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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

Conditions

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

Keywords

Ketamine; Orthopedic Trauma; Postoperative Pain; Opioid Reduction; Depression; PTSD; Musculoskeletal Injury; Trauma Surgery

Outcome Measures

Primary Outcomes (1)

• Pain Intensity (VAS)

  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.

  1-7 days, 2-3 weeks (±1 week), 6 weeks (±2 weeks), 3 months (±3 weeks), and 6 months (±5 weeks) postoperatively.

Secondary Outcomes (1)

• 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.

Other Outcomes (3)

• Depression Symptoms (PHQ-9)

  1-7 days, 2-3 weeks (±1 week), 6 weeks (±2 weeks), 3 months (±3 weeks), and 6 months (±5 weeks) postoperatively.

• PTSD Symptoms (PCL-5)

  1-7 days, 2-3 weeks (±1 week), 6 weeks (±2 weeks), 3 months (±3 weeks), and 6 months (±5 weeks) postoperatively.

• Adverse Events Related to Ketamine

  Monitored continuously through 6 months postoperatively.

Study Arms (2)

Ketamine Group

EXPERIMENTAL

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.

Drug: Ketamine

Control Group

ACTIVE COMPARATOR

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.

Drug: standard general anesthesia

Interventions

Ketamine DRUG

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).

Ketamine Group

standard general anesthesia DRUG

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

Study Sites (2)

Texas Tech University Health Sciences Center Lubbock

Lubbock, Texas, 79415, United States

RECRUITING

University Medical Center

Lubbock, Texas, 79415, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Depression; Stress Disorders, Post-Traumatic

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Max Evan Davis, MD

  Texas Tech University Health Sciences Center Department of Orthopaedic Surgery,

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Evan J Hernandez, MBA

CONTACT

8067436846; evan.j.hernandez@ttuhsc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will remain blinded to treatment allocation. Postoperative clinical care teams and outcome assessors are unblinded."
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 1, 2025
• Study Start: November 6, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)