Acute Pain, Chronic Pain, Knee Pain Chronic, Neuropathic Pain
Conditions
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.
Interventions
DRUGVenlafaxine 37.5 MG
venlafaxine 37.5mg daily for 7 consecutive days.
DRUGPlacebo
placebo filled pill daily for 7 consecutive days.
Sponsors
Orthopedic Research and Education Foundation
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative 24 hour total opioid consumption | 24 hours | morphine miligram equivalent |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain severity and interference at 7 days post operatively | 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. |
| Pain severity and interference at 3 months post operatively | 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. |
| Functionality at 7 days postoperatively | 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. |
| Pain numeric rating scale at 24 hours post operatively | 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. |
| Opioid consumption at 7 days postoperatively | 7 days | morphine miligram equivalent |
| Opioid consumption at 3 months postoperatively | 3 months | morphine miligram equivalent |
| Functionality at 3 months postoperatively | 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. |
Countries
United States
Outcome results
None listed