Recruiting

Ketamine

Sponsor:

Texas Tech University Health Sciences Center

Code:

NCT06903819

Conditions

Orthopedic Trauma Surgery Patients

Postoperative Pain

Opioid Use

Depression

Post-traumatic Stress Disorder (PTSD)

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Ketamine

standard general anesthesia

Study Details

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

Orthopedic Trauma Surgery Patients

Postoperative Pain

Opioid Use

Depression

Post-traumatic Stress Disorder (PTSD)

Study ID

NCT06903819

Start date

Nov 6, 2025

Status verified date

Mar, 2026

Completion date

May, 2028

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ketamine Group

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.

active comparator: Control Group

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.

Interventions

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).

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.

Primary outcome measure

  • Pain Intensity (VAS) [ Time Frame: 1-7 days, 2-3 weeks (±1 week), 6 weeks (±2 weeks), 3 months (±3 weeks), and 6 months (±5 weeks) postoperatively. ]

Central Contacts and Locations

Central contacts

Evan J Hernandez, MBA

8067436846evan.j.hernandez@ttuhsc.edu

Locations

Texas Tech University Health Sciences Center Lubbock

Recruiting

Lubbock, Texas, United States, 79415

Contacts

Evan J. Hernandez Project Manager, MBA

806-743-6846evan.j.hernandez@ttuhsc.edu

Principal Investigator:

Max E. Davis Assistant Professor, MD

University Medical Center

Recruiting

Lubbock, Texas, United States, 79415

Contacts

Ami Knox Program Director of Clinical Research, MBA

806-761-0575ami.knox@umchealthsystem.com

Principal Investigator:

Max E. Davis Assistant Professor, MD

More Information

Sponsor

Texas Tech University Health Sciences Center

Last update posted

Mar 24, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Texas Tech University Health Sciences Center on 2026-03-24.