The Use of Venlafaxine in Reducing Pain in Primary Total Knee Replacement
Primary Purpose
Acute Pain, Chronic Pain, Knee Pain Chronic
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Venlafaxine 37.5 MG
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pain
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.
Sites / Locations
- University of California San FranciscoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Venlafaxine
Arm Description
Subjects in placebo arm will receive inactive placebo capsule daily for 7 consecutive days starting on day of primary arthroplasty surgery.
Subjects in venlafaxine arm will receive venlafaxine 37.5mg daily for 7 consecutive days starting on day of primary arthroplasty surgery.
Outcomes
Primary Outcome Measures
Cumulative 24 hour total opioid consumption
morphine miligram equivalent
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
Opioid consumption at 7 days postoperatively
morphine miligram equivalent
Opioid consumption at 3 months postoperatively
morphine miligram equivalent
Full Information
NCT ID
NCT05023278
First Posted
July 19, 2021
Last Updated
July 5, 2022
Sponsor
University of California, San Francisco
Collaborators
Orthopedic Research and Education Foundation
1. Study Identification
Unique Protocol Identification Number
NCT05023278
Brief Title
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
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2021 (Actual)
Primary Completion Date
March 4, 2023 (Anticipated)
Study Completion Date
May 4, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Orthopedic Research and Education Foundation
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain, Chronic Pain, Knee Pain Chronic, Neuropathic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects in placebo arm will receive inactive placebo capsule daily for 7 consecutive days starting on day of primary arthroplasty surgery.
Arm Title
Venlafaxine
Arm Type
Experimental
Arm Description
Subjects in venlafaxine arm will receive venlafaxine 37.5mg daily for 7 consecutive days starting on day of primary arthroplasty surgery.
Intervention Type
Drug
Intervention Name(s)
Venlafaxine 37.5 MG
Other Intervention Name(s)
SNRI analgesia
Intervention Description
venlafaxine 37.5mg daily for 7 consecutive days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
control
Intervention Description
placebo filled pill daily for 7 consecutive days.
Primary Outcome Measure Information:
Title
Cumulative 24 hour total opioid consumption
Description
morphine miligram equivalent
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Pain numeric rating scale at 24 hours post operatively
Description
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.
Time Frame
24 hours
Title
Pain severity and interference at 7 days post operatively
Description
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.
Time Frame
7 days
Title
Pain severity and interference at 3 months post operatively
Description
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.
Time Frame
3 months
Title
Functionality at 7 days postoperatively
Description
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.
Time Frame
7 days
Title
Functionality at 7 days postoperatively
Description
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.
Time Frame
7 days
Title
Functionality at 3 months postoperatively
Description
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.
Time Frame
3 months
Title
Functionality at 3 months postoperatively
Description
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.
Time Frame
3 months
Title
Opioid consumption at 7 days postoperatively
Description
morphine miligram equivalent
Time Frame
7 days
Title
Opioid consumption at 3 months postoperatively
Description
morphine miligram equivalent
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah J Zhang, PhD
Phone
4086666312
Email
jingying.zhang@ucsf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Matthias Behrends, MD
Phone
4155143761
Email
matthias.behrends@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthias Behrends, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Zhang
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
We will share our raw clinical data with other researchers.
IPD Sharing Time Frame
For the entire study period
IPD Sharing Access Criteria
Non-profit and research purpose.
Learn more about this trial
The Use of Venlafaxine in Reducing Pain in Primary Total Knee Replacement
We'll reach out to this number within 24 hrs