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

Chronic Pain Clinical Trial

Official title:

The Use of Venlafaxine in Reducing Acute Post-Surgical Pain and Opioid Consumption in Primary Total Knee Replacement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05023278
• Other study ID #: 20-32595
• Status: Recruiting
• Phase: Phase 4
• Start date: May 10, 2021
• Est. completion date: March 31, 2025

Study information

• Verified date: February 2024
• Source: University of California, San Francisco
• Contact: Sarah J Zhang, PhD
• Phone: 4086666312
• Email: jingying.zhang[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain
• Chronic Pain
• Knee Pain Chronic
• Neuralgia
• Neuropathic Pain

Intervention

Drug:
• Venlafaxine 37.5 MG
venlafaxine 37.5mg daily for 7 consecutive days.
• Placebo
placebo filled pill daily for 7 consecutive days.

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Orthopedic Research and Education Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative 24 hour total opioid consumption	morphine miligram equivalent	24 hours
Secondary	Pain numeric rating scale at 24 hours post operatively	Pain Scores will be measured on the Numerical Rating Scale (NRS), the score ranges from 0-10, zero indicating no pain and 10 indicating the worst pain.	24 hours
Secondary	Pain severity and interference at 7 days post operatively	The Brief Pain Inventory (BPI) assesses the severity of pain and its impact on functioning.The BPI scale defines pain as follows:1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain.	7 days
Secondary	Pain severity and interference at 3 months post operatively	The Brief Pain Inventory (BPI) assesses the severity of pain and its impact on functioning.The BPI scale defines pain as follows:1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain.	3 months
Secondary	Functionality at 7 days postoperatively	Knee injury and osteoarthritis outcome score short form: Patient-Reported Outcomes Measurement Information System (PROMIS), item health survey. The PROMIS Global-10 is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The average Score is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.	7 days
Secondary	Functionality at 7 days postoperatively	Knee injury and osteoarthritis outcome score short form, veterans RAND 12 (VR12) item health survey. The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). The United States population average PCS and MCS are both 50 points. The United States population standard deviation is 10 points. Therefore, each increment of 10 points above or below 50 corresponds to one standard deviation away from the population average.	7 days
Secondary	Functionality at 3 months postoperatively	Knee injury and osteoarthritis outcome score short form: Patient-Reported Outcomes Measurement Information System (PROMIS), item health survey. The PROMIS Global-10 is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The average Score is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.	3 months
Secondary	Functionality at 3 months postoperatively	Knee injury and osteoarthritis outcome score short form, veterans RAND 12 (VR12) item health survey. The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). The United States population average PCS and MCS are both 50 points. The United States population standard deviation is 10 points. Therefore, each increment of 10 points above or below 50 corresponds to one standard deviation away from the population average.	3 months
Secondary	Opioid consumption at 7 days postoperatively	morphine miligram equivalent	7 days
Secondary	Opioid consumption at 3 months postoperatively	morphine miligram equivalent	3 months