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

RECRUITINGPhase 4Sponsored by Texas Tech University Health Sciences Center
Actively Recruiting
PhasePhase 4
SponsorTexas Tech University Health Sciences Center
Started2025-11-06
Est. completion2027-05
Eligibility
Age18 Years – 65 Years
Healthy vol.Accepted
Locations2 sites

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

Eligibility

Age: 18 Years – 65 YearsHealthy volunteers 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

Conditions5

DepressionOpioid UseOrthopedic Trauma Surgery PatientsPost Traumatic Stress Disorder (PTSD)Postoperative Pain

Locations2 sites

Texas Tech University Health Sciences Center Lubbock
Lubbock, Texas, 79415
Evan J. Hernandez Project Manager, MBA806-743-6846evan.j.hernandez@ttuhsc.edu
University Medical Center
Lubbock, Texas, 79415
Ami Knox Program Director of Clinical Research, MBA806-761-0575ami.knox@umchealthsystem.com

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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