100 Participants Needed

Venlafaxine for Knee Pain

SJ
MB
Overseen ByMatthias Behrends, MD
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

Patients experience pain after their knee replacement surgery - and some may continue to experience persistent pain long after their knee replacement surgery. Traditional pain management strategies reply on pain medication such as opioids for pain control. However, these drugs do not work well for pain associated with movement or the the nerve pain (tingling, electrical sensations) after surgery. In addition, opioids are associated with significant side effects such as nausea, vomiting, respiratory depression, depression, cognitive dysfunction and risk of persistent opioid use. Neuropathic pain medications, such as venlafaxine are effective in managing nerve pain. Recent studies also support its potential role in acute pain management. Here, we propose a prospective randomized clinical trial 1) to evaluate the efficacy of Venlafaxine in reducing pain intensity and opioid consumption at post-operative day 1 (POD1) and 1- week after surgery, and 2) to examine whether the use of Venlafaxine will reduce the incidents of chronic postsurgical pain in TKA patients at 3-month time point.

Will I have to stop taking my current medications?

You may need to stop taking certain medications. The trial excludes people who are currently using antidepressants, triptans, linezolid, or benzodiazepines.

Is venlafaxine safe for humans?

Venlafaxine has been shown to be generally safe and well-tolerated in humans, with common side effects including nausea, headache, and dizziness. Serious adverse events are rare, and its safety profile is similar to other modern antidepressants.12345

How is the drug venlafaxine unique for treating knee pain?

Venlafaxine is unique for treating knee pain because it is primarily an antidepressant that also has pain-relieving properties, particularly for neuropathic and inflammatory pain, which is not typical for most knee pain treatments. It works by affecting neurotransmitters (chemical messengers in the brain) like serotonin and noradrenaline, which can help manage pain and mood.26789

Who Is on the Research Team?

MB

Matthias Behrends, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

English speaking
I am scheduled for a knee replacement surgery with specific anesthesia and nerve block.

Exclusion Criteria

I have a bleeding disorder.
Chronic opioid use
Allergy to the study medications
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Venlafaxine 37.5 mg/d or a placebo starting on the day of surgery and continue for 7 days

1 week
Daily administration

Follow-up

Participants are monitored for pain severity, opioid consumption, and functionality at 7 days and 3 months post-surgery

3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Venlafaxine
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: VenlafaxineExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Venlafaxine is already approved in European Union, United States, Canada for the following indications:

🇪🇺
Approved in European Union as Efexor for:
🇺🇸
Approved in United States as Effexor for:
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Approved in Canada as Effexor for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

Orthopedic Research and Education Foundation

Collaborator

Trials
23
Recruited
6,200+

Published Research Related to This Trial

Venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor, was found to have a tolerability and safety profile similar to selective serotonin reuptake inhibitors, based on data from 3,082 patients, with most experiencing manageable side effects like nausea and insomnia.
Serious adverse events were rare, and while a small percentage of patients experienced modest increases in blood pressure, these were comparable to those seen with other antidepressants, indicating that venlafaxine is generally safe for both younger and older patients.
The safety and tolerability of venlafaxine hydrochloride: analysis of the clinical trials database.Rudolph, RL., Derivan, AT.[2022]
In a study involving 24 male rats with neuropathic pain, venlafaxine effectively prevented the development of thermal hyperalgesia, demonstrating its potential as a pain relief option without the sedative effects seen in other treatments.
Venlafaxine not only reversed existing thermal hyperalgesia in rats with established neuropathic pain but also showed a mild non-specific analgesic effect, indicating its efficacy in managing pain without significant side effects.
Venlafaxine hydrochloride (Effexor) relieves thermal hyperalgesia in rats with an experimental mononeuropathy.Lang, E., Hord, HA., Denson, D.[2022]
Venlafaxine is safe and well tolerated in patients with major depression, based on data from 19 studies involving 2181 patients, with a long-term safety evaluation in 422 patients treated for at least one year.
The adverse events associated with venlafaxine, such as nausea and headache, were common but comparable to those seen with third-generation antidepressants, and venlafaxine had a lower frequency of anticholinergic events compared to first-generation antidepressants.
Safety and tolerance profile of venlafaxine.Danjou, P., Hackett, D.[2019]

Citations

The safety and tolerability of venlafaxine hydrochloride: analysis of the clinical trials database. [2022]
Venlafaxine hydrochloride (Effexor) relieves thermal hyperalgesia in rats with an experimental mononeuropathy. [2022]
Safety and tolerance profile of venlafaxine. [2019]
Efficacy of venlafaxine for the long term treatment of chronic pain with associated major depressive disorder. [2022]
Venlafaxine extended release in the treatment of painful diabetic neuropathy: a double-blind, placebo-controlled study. [2022]
6.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Results of a study of velaxin (venlafaxine) efficacy in patients with subacute and chronic spondylogenic dorsalgia]. [2022]
Venlafaxine-tramadol similarities. [2019]
Protection against oxaliplatin acute neurosensory toxicity by venlafaxine. [2019]
Evaluation of antinociceptive and anti-inflammatory effects of venlafaxine in the rat. [2022]
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