Clinical trial

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

Name
20-32595
Description
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.
Trial arms
Trial start
2021-05-10
Estimated PCD
2024-12-31
Trial end
2025-03-31
Status
Recruiting
Phase
Early phase I
Treatment
Venlafaxine 37.5 MG
venlafaxine 37.5mg daily for 7 consecutive days.
Arms:
Venlafaxine
Other names:
SNRI analgesia
Placebo
placebo filled pill daily for 7 consecutive days.
Arms:
Placebo
Other names:
control
Size
100
Primary endpoint
Cumulative 24 hour total opioid consumption
24 hours
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2024-02-28

1 organization

1 product

1 drug

4 indications

Indication
Pain
Indication
Chronic Pain