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Recruiting NCT06373978

NonNarcotic Pain Control in Percutaneous Needle Tenotomy of Elbow

Phase IV Interventional Elbow Pain Chronic Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Diclofenac, Tramadol, Acetaminophen.
Who it may be relevant to
Registry conditions: Elbow Pain, Chronic Pain. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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) .

Interventions

  • 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

Primary outcome measures

  • Number of pills taken [Time frame: 10 days]
Secondary outcome measures (1)
  • Non narcotic use [Time frame: 10 days]

Eligibility criteria

Inclusion criteria

  • 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
  • Ability to take oral medication and willingness to participate in a 2-week follow-up pill counts
  • Musculoskeletal ultrasound or MRI with diagnosis of tendinosis of the common extensor tendon of the elbow

Exclusion criteria

  • • Any full thickness common extensor tendon tear of the elbow
  • Prior history of elbow surgery
  • Symptomatic cervical radiculopathy
  • Concurrent symptoms of the medial elbow
  • Treatment with another investigational drug or other intervention concurrently or previously that would interfere with postoperative pain control
  • Psychiatric illness that impedes evaluation of pain and/or narcotics use
  • No history of inflammatory arthritis, diabetes, chronic regional pain syndrome, connective tissue disease, fibromyalgia or autoimmune disease
  • No contraindications to NSAIDs or Opioids

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Supportive care

Study locations

United States · 2 centers
  • The Cleveland Clinic Florida — Coral Springs
  • The Cleveland Clinic Ohio — Avon

Identifiers

NCT: NCT06373978 · 24-307

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗