Clinical trial NCT05023278: The Use of Venlafaxine in Reducing Pain in Primary Total Knee Replacement
Official title: The Use of Venlafaxine in Reducing Acute Post-Surgical Pain and Opioid Consumption in Primary Total Knee Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Pain
Chronic Pain
Knee Pain Chronic
Neuropathic Pain
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Orthopedic Research and Education Foundation
First posted: 2021-08-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Cumulative 24 hour total opioid consumption
timeFrame: 24 hours
Secondary outcomes:
measure: Pain numeric rating scale at 24 hours post operatively
timeFrame: 24 hours
measure: Pain severity and interference at 7 days post operatively
timeFrame: 7 days
measure: Pain severity and interference at 3 months post operatively
timeFrame: 3 months
measure: Functionality at 7 days postoperatively
timeFrame: 7 days
measure: Functionality at 7 days postoperatively
timeFrame: 7 days
measure: Functionality at 3 months postoperatively
timeFrame: 3 months
measure: Functionality at 3 months postoperatively
timeFrame: 3 months
measure: Opioid consumption at 7 days postoperatively
timeFrame: 7 days
measure: Opioid consumption at 3 months postoperatively
timeFrame: 3 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Matthias Behrends, MD
role: PRINCIPAL_INVESTIGATOR
References: