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NCT Number: NCT06373978

NonNarcotic Pain Control in Percutaneous Needle Tenotomy of Elbow

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.

Recruiting

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Cleveland Clinic Florida, Coral Springs, Florida, United States

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About this study

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) .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diclofenac

Drug

50mg every 8hours as needed for pain

Tramadol

Drug

50mg every 8hours as needed for pain

Acetaminophen

Other

1000mg every 8hours as needed for pain

Primary outcomes

  1. Number of pills taken

    Time frame: 10 days

    The number of total Tramadol pills taken per patient between the control (Tramadol + Diclofenac rescue) vs experimental (Diclofenac + Tramadol rescue) groups at two weeks.

Secondary outcomes

  1. Non narcotic use

    Time frame: 10 days

    The percentage of patients randomized to Diclofenac that do not use any narcotic (Tramadol) rescue medication

Study contacts

Contact information is provided by the study sponsor or research team.

Erin Clancy, BA

CONTACT

[email protected]

2169706796

Jennifer Baldwin

CONTACT

[email protected]

216-390-5833

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 18, 2024
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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