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

Phase 4

Not yet recruiting

• Conditions: Orthopedic Trauma Surgery Patients; Postoperative Pain; Opioid Use; Post-traumatic Stress Disorder (PTSD); Depression
• Interventions: Drug: Ketamine; Drug: standard general anesthesia

• Registration Number: NCT06903819
• Lead Sponsor: Texas Tech University Health Sciences Center

Brief Summary

The goal of this clinical trial is to learn whether a single dose of ketamine during surgery can help lower pain, reduce the need for opioid medications, and improve mental health recovery in adults with serious orthopedic injuries. The main questions it aims to answer are:

Does ketamine lower pain after surgery? Does ketamine help reduce how much opioid medicine participants need? Does ketamine improve symptoms of depression and post-traumatic stress disorder (PTSD)? Researchers will compare participants who receive ketamine during surgery to those who receive standard anesthesia without ketamine.

Participants will:

Receive either ketamine or standard anesthesia during surgery Answer survey questions about pain, depression, and PTSD at several points after surgery (from a few days up to 6 months) Be followed by the research team through clinic visits and phone calls

Detailed Description

This randomized controlled trial will evaluate whether giving a single dose of intravenous (IV) ketamine during surgery can improve postoperative outcomes for adults with severe orthopedic injuries. Participants will be adults aged 18-65 undergoing surgery for musculoskeletal trauma at a Level I trauma center. All eligible participants will have an Injury Severity Score (ISS) greater than 15.

Participants will be randomly assigned to receive either standard general anesthesia or anesthesia with an added dose of IV ketamine (0.5 mg/kg). The study will track pain levels, opioid use, and symptoms of depression and post-traumatic stress disorder (PTSD) using validated surveys and pain rating scales. Outcomes will be measured at multiple points after surgery, including 1-7 days, 2-3 weeks, 3 months, and 6 months.

This study will help determine if ketamine can improve both physical and mental recovery in people with complex orthopedic trauma, and whether it should be considered as part of routine trauma care.

Study Timeline

• Study First Submitted: 2025-03-25
• Study First Submitted QC: 2025-03-25
• Study First Posted: 2025-04-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18
• Study Start: 2025-06
• Primary Completion: 2027-05
• Study Completion: 2028-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamine Group	Ketamine	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.
Control Group	standard general anesthesia	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 Measures

Name	Time	Method
Pain Intensity After Surgery	Measured at 1-7 days, 2-3 weeks, 3 months, and 6 months postoperatively	Pain intensity will be measured using the Visual Analog Scale (VAS), a validated tool where participants rate their pain on a scale from 0 (no pain) to 10 (worst imaginable pain). This outcome will help assess the effectiveness of intraoperative ketamine in reducing postoperative pain compared to standard anesthesia.

Secondary Outcome Measures

Name	Time	Method
Postoperative Opioid Consumption	Measured cumulatively at 1-7 days, 2-3 weeks, 3 months, and 6 months postoperatively	Total opioid use will be measured in oral morphine milligram equivalents (MME). This will assess whether intraoperative ketamine reduces opioid requirements compared to the control group.

Trial Locations

Locations (2)

Texas Tech University Health Sciences Center Lubbock; 🇺🇸 Lubbock, Texas, United States

University Medical Center; 🇺🇸 Lubbock, Texas, United States