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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

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).
• 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.

Study Details

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

Key Dates

Start date

Nov 6, 2025

Status verified

Mar 2026

Primary completion

May 31, 2027

Completion

May 31, 2028

Study Design

Enrollment

90 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.

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

• Evan J Hernandez, MBA
  8067436846
  [email protected]

Locations (2)

Find similar trials in Lubbock, TX

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