RecruitingPhase 4NCT06373978

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


Sponsor

The Cleveland Clinic

Enrollment

92 participants

Start Date

Aug 12, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria6

  • 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 Criteria8

  • 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

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Interventions

DRUGDiclofenac

50mg every 8hours as needed for pain

DRUGTramadol

50mg every 8hours as needed for pain

OTHERAcetaminophen

1000mg every 8hours as needed for pain


Locations(2)

The Cleveland Clinic Florida

Coral Springs, Florida, United States

The Cleveland Clinic Ohio

Avon, Ohio, United States

View Full Details on ClinicalTrials.gov

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NCT06373978


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