Actively Recruiting
Alternative Post Procedural Analgesia With NSAIDs vs Opioids in Percutaneous Needle Tenotomy of Elbow: A Randomized Controlled Trial
Led by The Cleveland Clinic · Updated on 2026-02-13
92
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare the effectiveness of different pain medications for people undergoing an ultrasound-guided percutaneous needle tenotomy on the lateral elbow. The study evaluates oral acetaminophen, diclofenac, and tramadol to see which best reduces the use of narcotic pain medication and limits patients' exposure to narcotics after the procedure. It is a double-blind, randomized controlled trial designed to provide clear comparisons among these treatments. Participants will receive one of three medication regimens right after their tenotomy procedure. Acetaminophen (1000 mg) will be taken every 8 hours if pain is present and is suggested as the first medication for pain. Patients will then take blinded capsules containing either diclofenac potassium (50 mg) or tramadol (50 mg) every 8 hours as needed. If pain continues an hour after taking the study medication, a rescue medication will be provided: tramadol for those on diclofenac and diclofenac for those on tramadol. These medications come in identical capsules to keep the study blinded. During the study, participants will have in-person visits about 10 days after the procedure to check pill counts and monitor narcotic use. Researchers will measure the total number of tramadol doses taken as the main outcome and also track non-narcotic medication use. Participants must be available for follow-up and able to take oral medication throughout the study period, which lasts around two weeks after the procedure.
CONDITIONS
Brief Title
NonNarcotic Pain Control in Percutaneous Needle Tenotomy of Elbow
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Willingness to comply with study procedures and availability for the study duration
- Male or female, aged 18-65 years
- Scheduled for percutaneous needle tenotomy of the lateral elbow
- Ability to take oral medication and willingness to participate in a 2-week follow-up with pill counts
- Diagnosis of tendinosis of the common extensor tendon of the elbow confirmed by musculoskeletal ultrasound or MRI
You will not qualify if you...
- Full thickness common extensor tendon tear of the elbow
- Prior history of elbow surgery
- Symptomatic cervical radiculopathy
- Symptoms affecting the medial elbow
- Current or prior treatment with another investigational drug or intervention interfering with postoperative pain control
- Psychiatric illness affecting pain or narcotic use evaluation
- History of inflammatory arthritis, diabetes, chronic regional pain syndrome, connective tissue disease, fibromyalgia, or autoimmune disease
- Contraindications to NSAIDs or opioids
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Immediately after procedure and up to 10 days
Participants receive percutaneous needle tenotomy of the lateral elbow followed by assigned pain control medication taken every 8 hours as needed.
1 in-person visit for procedure and medication administration; participants take medications at home as needed
Duration - 10 days (± 4 days) after procedure
Participants return for an in-person visit for pill counts and assessment of medication use and pain control.
1 in-person visit
Trial Site Locations
Total: 2 locations
1
The Cleveland Clinic Florida
Coral Springs, Florida, United States, 33067
Actively Recruiting
2
The Cleveland Clinic Ohio
Avon, Ohio, United States, 44011
Actively Recruiting
Research Team
E
Erin Clancy, BA
J
Jennifer Baldwin
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
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