NCT06373978

NonNarcotic Pain Control in Percutaneous Needle Tenotomy of Elbow

A Randomized Controlled Trial: Alternative Post Procedural Analgesia With NSAIDs vs Opioids in Percutaneous Needle Tenotomy of Elbow

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Tramadol is currently the standard post-procedure medication. Acetaminophen will be prescribed (1000 mg) and should be taken every 8 hours if pain is present. Tylenol should be the first taken for pain. If pain persist, the study kit containing the blinded, pain-controlled capsules will be taken second. Both diclofenac potassium (50mg) and tramadol (50mg) will be provided in identical-looking capsules and randomly assigned to patients in sealed packets by a physician, ensuring the double-blind nature of the study and be instructed to use every 8 hours as needed for pain If pain is still not adequately controlled an hour after taking the blinded study pack, a rescue medication, consisting of tramadol 50mg capsules, will also be supplied to the NSAID group in sealed packets while rescue medication of oral diclofenac will be provided to the opioid group. These medications will be administered immediately after the tenotomy procedure to all participants. The primary endpoint of the study will be the total count of tramadol doses taken by each group at the 10 day (± 4 days) postoperative follow-up. Pill counts from sealed packages and the use of rescue narcotics will be verified during the in-person visit at 10 days (± 4 days) .

Conditions

• Elbow Pain
• Chronic Pain

Interventions

Type	Name	Description
DRUG	Diclofenac	50mg every 8hours as needed for pain
DRUG	Tramadol	50mg every 8hours as needed for pain
OTHER	Acetaminophen	1000mg every 8hours as needed for pain

Timeline

• Start date: 2024-08-12
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2024-04-18
• Last updated: 2026-02-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study