The Use of Venlafaxine in Reducing Pain in Primary Total Knee Replacement

NCT05023278 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: 20-32595
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Pain; Chronic Pain; Knee Pain Chronic; Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• Cumulative 24 hour total opioid consumption

  morphine miligram equivalent

  24 hours

Secondary Outcomes (9)

• Pain numeric rating scale at 24 hours post operatively

  24 hours

• Pain severity and interference at 7 days post operatively

  7 days

• Pain severity and interference at 3 months post operatively

  3 months

• Functionality at 7 days postoperatively

  7 days

• Functionality at 7 days postoperatively

  7 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Subjects in placebo arm will receive inactive placebo capsule daily for 7 consecutive days starting on day of primary arthroplasty surgery.

Drug: Placebo

Venlafaxine

EXPERIMENTAL

Subjects in venlafaxine arm will receive venlafaxine 37.5mg daily for 7 consecutive days starting on day of primary arthroplasty surgery.

Drug: Venlafaxine 37.5 MG

Interventions

Venlafaxine 37.5 MG DRUG

venlafaxine 37.5mg daily for 7 consecutive days.

Also known as: SNRI analgesia

Venlafaxine

Placebo DRUG

placebo filled pill daily for 7 consecutive days.

Also known as: control

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult (male and female) subjects aged 18 to 75,
• English speaking,
• are scheduled for primary total knee arthroplasty with planned spinal anesthesia with saphenous peripheral nerve block at the adductor canal.

You may not qualify if:

• general anesthesia,
• hepatic \& renal failure,
• history of diabetic peripheral neuropathic pain,
• chronic opioid use,
• concurrent use of antidepressants, triptans, and/or linezolid,
• allergy to the study medications,
• prior knee surgery,
• BMI \> 40,
• bleeding disorders,
• history of recent falls,
• concurrent benzodiazepine use.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Orthopedic Research and Education Foundation: collaborator

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Acute Pain; Chronic Pain; Neuralgia

Interventions

Venlafaxine Hydrochloride

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Phenethylamines; Ethylamines; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Lipids

Study Officials

• Matthias Behrends, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: August 26, 2021
• Study Start: May 10, 2021
• Primary Completion: February 28, 2025
• Study Completion: March 31, 2025
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: For the entire study period
• Access Criteria: Non-profit and research purpose.

Locations

US (1)