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

NCT ID: NCT05023278

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-10
• Study Completion Date: 2025-03-31

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.

Detailed Description

Patients meeting the inclusion criteria will be randomized to receive either Venlafaxine extended release (ER) 37.5 mg/d or a placebo on the day of surgery and continue the treatment for 7 days after surgery. The primary outcomes include pain severity score (numeric rating scale, NRS) and consumption of morphine miligram equivalent (MME) at 24 hours. The secondary outcome will measure MME and NRS at postoperative day 7. In addition, the disability scale and perceived function 3 months after surgery will be compared to the baseline level by using PROMIS (Patient-Reported Outcomes Measurement Information System)10 Global Health, KOOS, JR. (Knee injury and Osteoarthritis Outcome Score Short Form), and VR-12 (Veterans RAND 12 Item Health Survey) Scale.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo filled pill daily for 7 consecutive days.

Venlafaxine

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

Group Type: EXPERIMENTAL

Venlafaxine 37.5 MG

Intervention Type: DRUG

venlafaxine 37.5mg daily for 7 consecutive days.

Interventions

Venlafaxine 37.5 MG

venlafaxine 37.5mg daily for 7 consecutive days.

Intervention Type: DRUG

Placebo

placebo filled pill daily for 7 consecutive days.

Intervention Type: DRUG

Other Intervention Names

SNRI analgesia; control

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Orthopedic Research and Education Foundation

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthias Behrends, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

20-32595

Identifier Type: -

Identifier Source: org_study_id