Clinical trial NCT06373978: NonNarcotic Pain Control in Percutaneous Needle Tenotomy of Elbow
Official title: A Randomized Controlled Trial: Alternative Post Procedural Analgesia With NSAIDs vs Opioids in Percutaneous Needle Tenotomy of Elbow
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Elbow Pain
Chronic Pain
Keywords: TenJet
Elbow
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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) .

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

Primary outcomes:
measure: Number of pills taken
timeFrame: 10 days
Secondary outcomes:
measure: Non narcotic use
timeFrame: 10 days
Other outcomes:
Locations:
city: Coral Springs
country: United States
facility: The Cleveland Clinic Florida
state: Florida
city: Avon
country: United States
facility: The Cleveland Clinic Ohio
state: Ohio
Study officials:
affiliation: Cleveland Clinic Florida
name: Michael Dakkak, DO
role: PRINCIPAL_INVESTIGATOR
References: