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Serotonin-Norepinephrine Reuptake Inhibitor

Venlafaxine for Knee Pain

Phase 4
Recruiting
Led By Matthias Behrends, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult (male and female) subjects aged 18 to 75
Scheduled for primary total knee arthroplasty with planned spinal anesthesia with saphenous peripheral nerve block at the adductor canal
Must not have
Bleeding disorders
Hepatic & renal failure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial is investigating whether Venlafaxine can help manage pain better than opioids after knee surgery, as well as reducing the risk of chronic pain.

Who is the study for?
This trial is for English-speaking adults aged 18 to 75 who are scheduled for primary total knee replacement surgery with specific anesthesia. It's not for those on antidepressants, triptans, or linezolid; with allergies to study meds; BMI over 40; prior knee surgery; recent falls; liver/renal failure; bleeding disorders; general anesthesia use; diabetic nerve pain history or chronic opioid/benzodiazepine users.
What is being tested?
The trial tests if Venlafaxine (37.5 MG) can reduce pain and opioid use after knee replacement compared to a placebo. The focus is on the first day post-op and one week later, plus checking if it lowers long-term chronic pain at three months.
What are the potential side effects?
Venlafaxine may cause side effects like nausea, vomiting, dizziness, dry mouth, sleepiness or insomnia. Unlike opioids, it's less likely to cause respiratory issues but could affect mood and cognitive functions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 75 years old.
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I am scheduled for a knee replacement surgery with specific anesthesia and nerve block.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a bleeding disorder.
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I do not have liver or kidney failure.
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I have experienced nerve pain due to diabetes.
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I have fallen recently.
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I will undergo surgery with general anesthesia.
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I am currently taking benzodiazepines.
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I am currently taking antidepressants, triptans, or linezolid.
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I have had knee surgery before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cumulative 24 hour total opioid consumption
Secondary study objectives
Functionality at 3 months postoperatively
Functionality at 7 days postoperatively
Opioid consumption at 3 months postoperatively
+4 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: VenlafaxineExperimental Treatment1 Intervention
Subjects in venlafaxine arm will receive venlafaxine 37.5mg daily for 7 consecutive days starting on day of primary arthroplasty surgery.
Group II: PlaceboPlacebo Group1 Intervention
Subjects in placebo arm will receive inactive placebo capsule daily for 7 consecutive days starting on day of primary arthroplasty surgery.

Find a Location

Who is running the clinical trial?

Orthopedic Research and Education FoundationOTHER
20 Previous Clinical Trials
5,570 Total Patients Enrolled
University of California, San FranciscoLead Sponsor
2,587 Previous Clinical Trials
14,901,076 Total Patients Enrolled
13 Trials studying Chronic Pain
1,707 Patients Enrolled for Chronic Pain
Matthias Behrends, MDPrincipal InvestigatorUniversity of California, San Francisco
2 Previous Clinical Trials
200 Total Patients Enrolled
~2 spots leftby Dec 2024
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