NonNarcotic Pain Control in Percutaneous Needle Tenotomy of Elbow

Status Not yet recruiting

Clinical Trial Summary

This study is a double-blind, randomized controlled trial comparing the effectiveness of oral Diclofenac and Tramadol in reducing the consumption of narcotic pills (primary outcome) and minimizing patients' exposure to narcotics (secondary outcome) following an ultrasound-guided percutaneous needle tenotomy procedure on the lateral elbow. The primary objective of this study is to illustrate a reduction in the consumption of narcotic pills following a percutaneous needle tenotomy procedure on the lateral elbow. The secondary aim is to assess the proportion of patients who have been randomly assigned to Diclofenac and successfully refrain from using the Tramadol rescue medication, measured at the 10 day (+/- 4 days) postoperative mark. The third objective is to uphold consistent early recovery outcomes as measured by the Patient-Rated Tennis Elbow Evaluation (PRTEE) and Quick Disability of Arm, Shoulder, and Hand (QuickDASH) scores after percutaneous needle tenotomy of the lateral elbow, while also investigating the relationship between resiliency and pain catastrophizing in relation to Tramadol usage and response to Diclofenac.

Clinical Trial Description

This study will be a double-blind, randomized trial comparing a control group receiving the standard care narcotic Tramadol (50mg) to an experimental group receiving Diclofenac (50mg). Both medications will be disguised in identical encapsulated pills and distributed in sealed packets. Participants will be advised against taking any other NSAIDs, but may use Tylenol (1000mg every 8 hours) and apply ice or heat as necessary. In case of severe pain following the tenotomy procedure, patients can choose to take either Tramadol (control) or Diclofenac (experimental) orally every 8 hours for the first 72 hours, totaling 9 pills. Additionally, an emergency packet containing 9 pills of Diclofenac (50mg every 8 hours) will be given to the control group, while the experimental group will receive 9 pills of Tramadol (50mg every 8 hours) to be taken as needed for breakthrough pain. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06373978
Study type	Interventional
Source	The Cleveland Clinic
Contact	Jennifer Baldwin
Phone	216.390.5833
Email	baldwij@ccf.org
Status	Not yet recruiting
Phase	Phase 4
Start date	June 1, 2024
Completion date	December 1, 2025

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.