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NMDA Receptor Antagonist

Ketamine for Postoperative Pain in Joint Replacement Surgery

Phase < 1
Waitlist Available
Led By Wayne E Moschetti, MD, MS
Research Sponsored by Dartmouth-Hitchcock Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults, 18 years and older, undergoing primary total hip arthroplasty or total knee arthroplasty
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-operation, post-operation at 6 weeks, 12 weeks, and 6 months
Awards & highlights

Study Summary

This trial will study whether ketamine can reduce pain and post-operative analgesic requirements in patients with high levels of pain catastrophizing undergoing total hip or total knee arthroplasty.

Who is the study for?
This trial is for adults over 18 who are having hip or knee replacement surgery and tend to experience high levels of pain. It's not for those unable to consent, currently incarcerated, pregnant or breastfeeding women, people allergic to ketamine, or with certain eye pressure issues, uncontrolled blood pressure, brain pressure problems, or psychosis.Check my eligibility
What is being tested?
The study tests if giving ketamine during the operation can reduce pain after hip or knee replacements in patients prone to severe pain. Participants will be randomly assigned to receive either ketamine or a placebo without knowing which one they get.See study design
What are the potential side effects?
Ketamine may cause side effects like changes in blood pressure and heart rate, dizziness, nausea, blurred vision, feelings of detachment from reality (dissociation), hallucinations (seeing things that aren't there), and allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am an adult having a first-time hip or knee replacement.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-operation at 6 weeks, 12 weeks, and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and post-operation at 6 weeks, 12 weeks, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Total Morphine consumption during the first 48 hours post surgery
Secondary outcome measures
Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS, JR.)
Knee Disability and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.)
Pain Catastrophizing Scale (PCS)
+1 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Racemic KetamineActive Control1 Intervention
ketamine 0.5mg/kg bolus on induction of anesthesia and 10mcg/kg/min infusion initiated prior to incision and terminated at the completion of wound closure. Maximum ketamine dose will not exceed 500mg
Group II: SalinePlacebo Group1 Intervention
saline in the same volume as the study drug, administered in the exact same format.

Find a Location

Who is running the clinical trial?

Dartmouth-Hitchcock Medical CenterLead Sponsor
522 Previous Clinical Trials
2,542,294 Total Patients Enrolled
Wayne E Moschetti, MD, MSPrincipal InvestigatorDartmouth-Hitchcock Medical Center

Media Library

Ketamine (NMDA Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04437888 — Phase < 1
Joint Replacement Surgery Research Study Groups: Racemic Ketamine, Saline
Joint Replacement Surgery Clinical Trial 2023: Ketamine Highlights & Side Effects. Trial Name: NCT04437888 — Phase < 1
Ketamine (NMDA Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04437888 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the research project currently open to enrollment?

"Affirmative. Clinicaltrials.gov documents that this medical trial, which was first launched on September 14th 2020, is actively looking for enrollees. There are currently 200 vacancies to be filled at a single clinic setting."

Answered by AI

What is the absolute highest amount of individuals who have taken part in this trial?

"Affirmative. According to clinicaltrials.gov, enrollment for this medical trial is still open and recruitment began on September 14th 2020. The latest update was August 24th 2022; the total sample size needed is 200 patients at a single location."

Answered by AI
~9 spots leftby Jun 2024