Ketamine for Orthopedic Surgery Patients

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether ketamine administered during surgery can improve recovery for adults with serious orthopedic injuries. Researchers aim to determine if ketamine reduces pain, lowers opioid use, and improves mental health issues such as depression and PTSD after surgery. Participants will receive either ketamine or standard anesthesia and will monitor their pain and mood during recovery. Suitable candidates for this trial are adults undergoing surgery for severe bone or muscle injuries who can provide consent. As a Phase 4 trial, this research seeks to understand how ketamine, an FDA-approved treatment, benefits more patients.

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.

What is the safety track record for ketamine?

Research has shown that ketamine can be a safe option for managing pain in surgery patients. Studies have found that ketamine can lessen pain and reduce the need for opioids, which are strong painkillers often used after surgery. Evidence indicates that ketamine not only helps with pain but also decreases nausea and vomiting after surgery. Some studies even suggest that patients experience fewer side effects, such as itchiness and drowsiness, when ketamine is used compared to other pain treatments.

Ketamine is already used in some medical treatments, providing insight into its safety. While risks exist, such as potential liver issues with long-term use, this study involves only a single dose, reducing the likelihood of such problems. Overall, findings suggest that ketamine is generally well-tolerated and could be a promising option for managing pain after orthopedic surgery. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using ketamine for orthopedic surgery patients because it offers a unique approach to managing postoperative pain and psychological recovery. Unlike traditional pain management options that rely heavily on opioids, ketamine works as an NMDA receptor antagonist, potentially reducing the need for opioids and minimizing their side effects. Additionally, ketamine may help with symptoms of depression and PTSD, which are not typically addressed by standard postoperative care. This multi-faceted impact makes ketamine a promising addition to current treatment strategies following musculoskeletal trauma surgery.

What evidence suggests that ketamine might be an effective treatment for improving recovery after orthopedic surgery?

In this trial, participants in the Ketamine Group will receive a single intraoperative dose of intravenous (IV) ketamine to assess its effects on postoperative pain, opioid use, and symptoms of depression and PTSD. Previous studies have shown that ketamine can reduce pain after bone surgeries, with patients needing fewer opioid painkillers in the first 24 hours post-surgery. This reduction is important because it lowers the risk of opioid addiction. Additionally, research indicates that ketamine can improve mental health by reducing depression and PTSD in patients after surgery. Overall, evidence supports ketamine as a helpful treatment for both physical and mental recovery in patients with bone injuries. ^{1 6 7 8 9}

Who Is on the Research Team?

Max Evan Davis, 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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10620013/

Ketamine in Trauma: A Literature Review and Administration ... This concluded that ketamine alone is effective and provides fewer side effects compared to opioid analgesia but offers more effective pain ...

2. rothmanopioid.org rothmanopioid.org/post/the-role-of-ketamine-for-pain-management-in-orthopedic-surgery

The Role of Ketamine for Pain Management in Orthopedic ... Ketamine has been shown to decrease opiate consumption 24 hours postoperatively across a variety of orthopedic procedures.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0020138325001883

Efficacy of intranasal ketamine in controlling pain caused ... The results of this study showed significant effects of intranasal ketamine and intravenous ketamine in reducing pain in patients with bone fractures.

4. bjanaesthesia.org.uk bjanaesthesia.org.uk/article/S0007-0912(19)30499-4/fulltext

Low-dose ketamine in painful orthopaedic surgery Low-dose ketamine is an effective adjuvant that decreases pain and opioid requirements in painful orthopaedic procedures, especially in the first 24 h after ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07059429?viewType=Table&rank=10

Ketamine Administration for Postoperative Pain ... This study is conducted to evaluate the effectiveness and safety of ketamine infusion for pain relief after knee replacement surgery.

6. cureus.com cureus.com/posters/3035-evaluating-the-efficacy-and-safety-of-perioperative-ketamine-as-an-adjunct-to-opioids-for-acute-postoperative-pain-management-following-orthopedic-procedures-a-systematic-review

Evaluating The Efficacy and Safety of Perioperative ... In studies reporting adverse events, a reduction in postoperative pruritus and sedation was found in groups receiving ketamine, while other ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0007091219304994

Low-dose ketamine in painful orthopaedic surgery Our results are consistent with those reported by Laskowski and colleagues, showing a benefit in orthopaedic patients in terms of opioid use and pain control.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11679605/

The Impact of Ketamine on Outcomes in Acute Pain ... Evidence shows that intravenous ketamine reduces the pain intensity, postoperative opioid use, and the risk of vomiting and nausea while improving analgesia.

9. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1155/2023/1928969

Application of Ketamine in Pain Management and the ... Also, the risk of ketamine-induced liver injury increases when the infusion is prolonged and/or repeated over a short period of time [52].