NonNarcotic Pain Control in Percutaneous Needle Tenotomy of Elbow
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThe Cleveland Clinic
About this trial
This study is a double-blind, randomized controlled trial comparing the effectiveness of oral acetaminophen, diclofenac, and tramadol in reducing the consumption of narcotic doses (primary outcome) and minimizing patients' exposure to narcotics (secondary outcome) following an ultrasound-guided percutaneous needle tenotomy procedure on the lateral elbow.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, aged 18-65 years
Percutaneous Needle Tenotomy of Lateral Elbow Procedure
Disqualifiers
• Any full thickness common extensor tendon tear of the elbow
Prior history of elbow surgery
Symptomatic cervical radiculopathy
Concurrent symptoms of the medial elbow
Trial design
Design model
Parallel
Treatments tested in this trial
Diclofenac
Drug50mg every 8hours as needed for pain
Tramadol
Drug50mg every 8hours as needed for pain
Acetaminophen
Other intervention1000mg every 8hours as needed for pain
Treatment groups
92 Participants
are divided into 3 treatment groupsGroup A: DiclofenacActive comparator 2 interventions
Group B: TramadolActive comparator 2 interventions
Group C: AcetaminophenSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of pills taken
The number of total Tramadol pills taken per patient between the control (Tramadol + Diclofenac rescue) vs experimental (Diclofenac + Tramadol rescue) groups at two weeks.
Time frame
10 daysSecondary outcomes
1
Non narcotic use
The percentage of patients randomized to Diclofenac that do not use any narcotic (Tramadol) rescue medication
Time frame
10 daysSponsors and contacts
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Source ClinicalTrials.gov