Ketamine for Orthopedic Surgery Patients

Recruiting at 1 trial location

Overseen By Evan J Hernandez, MBA

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Texas Tech University Health Sciences Center

Must not be taking: Ketamine

Disqualifiers: Severe psychiatric, Dementia, Glaucoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: Single dose during surgery

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are using ketamine for sedation or have certain psychiatric conditions, you may not be eligible to participate.

Is ketamine safe for use in orthopedic surgery patients?

Research shows that low-dose ketamine is generally safe for use in orthopedic surgeries like hip and knee replacements, with studies focusing on its pain-relief benefits and safety profile. While ketamine can have adverse effects, these are well-known and typically manageable, especially at low doses used in these settings. ^{1 2 3 4 5}

How is the drug ketamine unique for orthopedic surgery patients?

Ketamine is unique for orthopedic surgery patients because it is used in low doses to manage pain and has the added benefit of potentially improving mood after surgery. Unlike traditional pain medications, ketamine works by blocking specific receptors in the brain, which can help reduce the need for opioids and improve recovery. ^{1 4 5 6 7}

What data supports the effectiveness of the drug ketamine for orthopedic surgery patients?

Research shows that ketamine can help reduce pain and the need for other pain medications after orthopedic surgeries, like knee and hip replacements. It also has a positive effect on mood, helping to prevent feelings of depression after surgery. ^{4 7 8 9 10}

Who Is on the Research Team?

Max E. Davis Assistant Professor, MD

Principal Investigator

Texas Tech University Health Sciences Center Department of Orthopaedic Surgery,

Are You a Good Fit for This Trial?

This trial is for adults with serious orthopedic injuries who are undergoing surgery. Participants should be experiencing postoperative pain and may also have depression or PTSD. The study excludes individuals based on specific criteria not provided here.

Inclusion Criteria

I am having surgery for a recent bone or muscle injury.

Ability to provide informed consent (or consent provided by a legally authorized representative)

Injury Severity Score (ISS) greater than 15

Exclusion Criteria

I have used ketamine for sedation before or after surgery.

I am allergic to or cannot take ketamine.

I have a history of dementia or glaucoma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either ketamine or standard anesthesia during surgery

Single dose during surgery

1 visit (in-person)

Follow-up

Participants are monitored for pain, opioid use, and mental health recovery through surveys and clinic visits

6 months

Multiple visits (in-person and phone calls) at 1-7 days, 2-3 weeks, 3 months, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Ketamine

Trial Overview The study tests if a single dose of ketamine during surgery can reduce pain, lower opioid use, and improve mental health outcomes compared to standard anesthesia. Patients will be monitored through surveys and follow-ups for up to 6 months.

How Is the Trial Designed?

Group I: Ketamine Group Experimental Treatment 1 Intervention

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.

Group II: Control Group Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Texas Tech University Health Sciences Center

Lead Sponsor

Trials

107

Recruited

11,500+

Published Research Related to This Trial

A systematic review of 36 randomized controlled trials involving 3572 patients found that perioperative intravenous ketamine does not significantly reduce the incidence of chronic postsurgical pain after 6 months compared to placebo.

However, ketamine may lower the incidence of chronic postsurgical neuropathic pain after 3 months, although it also increases the risk of postoperative side effects like nystagmus and visual disturbances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of perioperative ketamine for the prevention of chronic postsurgical pain: A meta-analysis. Abouarab, AH., Brülle, R., Aboukilila, MY., et al.[2023]

A meta-analysis of six randomized controlled trials found that ketamine significantly reduces pain scores and cumulative morphine consumption in the first 24 hours after total knee arthroplasty, indicating its efficacy as a pain management option.

Ketamine also lowers the incidence of nausea and vomiting compared to placebo, without increasing the risk of thrombosis, suggesting it is a safer alternative for postoperative pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketamine reduces pain and opioid consumption after total knee arthroplasty: A meta-analysis of randomized controlled studies. Li, Z., Chen, Y.[2019]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Utilization of Ketamine in Total Knee and Hip Joint Arthroplasty: An Evidence-Based Review. [2023]

2. Japan pubmed.ncbi.nlm.nih.gov

Effect of intraoperative application of ketamine on postoperative depressed mood in patients undergoing elective orthopedic surgery. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review of Intra-Articular Ketamine for Postoperative Analgesia. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Low-dose ketamine in painful orthopaedic surgery: a systematic review and meta-analysis. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of perioperative ketamine for the prevention of chronic postsurgical pain: A meta-analysis. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review of the Efficacy and Safety of Ketamine in Total Joint Arthroplasty. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Adverse Drug Effects and Preoperative Medication Factors Related to Perioperative Low-Dose Ketamine Infusions. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Ketamine reduces pain and opioid consumption after total knee arthroplasty: A meta-analysis of randomized controlled studies. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Analgesic efficacy and safety of ketamine after total knee or hip arthroplasty: a meta-analysis of randomised placebo-controlled studies. [2020]

10. Brazil pubmed.ncbi.nlm.nih.gov

Inkk Trial .Çô Intraoperative ketamine for perioperative pain management following total knee endoprosthetic replacement in oncology: a double-blinded randomized trial. [2023]