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

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ClinicalTrials.gov Identifier: NCT05023278
Recruitment Status : Recruiting
First Posted : August 26, 2021
Last Update Posted : August 26, 2021
Sponsor:
Collaborator:
Orthopedic Research and Education Foundation
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Acute Pain Chronic Pain Knee Pain Chronic Neuropathic Pain Drug: Venlafaxine 37.5 MG Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of Venlafaxine in Reducing Acute Post-Surgical Pain and Opioid Consumption in Primary Total Knee Replacement
Actual Study Start Date : May 10, 2021
Estimated Primary Completion Date : February 4, 2022
Estimated Study Completion Date : May 4, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Placebo Comparator: Placebo
Subjects in placebo arm will receive inactive placebo capsule daily for 7 consecutive days starting on day of primary arthroplasty surgery.
Drug: Placebo
placebo filled pill daily for 7 consecutive days.
Other Name: control

Experimental: Venlafaxine
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
venlafaxine 37.5mg daily for 7 consecutive days.
Other Name: SNRI analgesia




Primary Outcome Measures :
  1. Cumulative 24 hour total opioid consumption [ Time Frame: 24 hours ]
    morphine miligram equivalent


Secondary Outcome Measures :
  1. Pain numeric rating scale at 24 hours post operatively [ Time Frame: 24 hours ]
    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.

  2. Pain severity and interference at 7 days post operatively [ Time Frame: 7 days ]
    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. Pain severity and interference at 3 months post operatively [ Time Frame: 3 months ]
    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.

  4. Functionality at 7 days postoperatively [ Time Frame: 7 days ]
    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.

  5. Functionality at 7 days postoperatively [ Time Frame: 7 days ]
    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.

  6. Functionality at 3 months postoperatively [ Time Frame: 3 months ]
    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. Functionality at 3 months postoperatively [ Time Frame: 3 months ]
    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.

  8. Opioid consumption at 7 days postoperatively [ Time Frame: 7 days ]
    morphine miligram equivalent

  9. Opioid consumption at 3 months postoperatively [ Time Frame: 3 months ]
    morphine miligram equivalent



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05023278


Contacts
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Contact: Sarah J Zhang, PhD 4086666312 jingying.zhang@ucsf.edu
Contact: Matthias Behrends, MD 4155143761 matthias.behrends@ucsf.edu

Locations
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United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Sarah Zhang         
Sponsors and Collaborators
University of California, San Francisco
Orthopedic Research and Education Foundation
Investigators
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Principal Investigator: Matthias Behrends, MD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05023278    
Other Study ID Numbers: 20-32595
First Posted: August 26, 2021    Key Record Dates
Last Update Posted: August 26, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will share our raw clinical data with other researchers.
Supporting Materials: Study Protocol
Time Frame: For the entire study period
Access Criteria: Non-profit and research purpose.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Neuralgia
Chronic Pain
Acute Pain
Pain
Neurologic Manifestations
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Venlafaxine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs