NonNarcotic Pain Control in Percutaneous Needle Tenotomy of Elbow

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06373978
• Other study ID #: 24-307
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 1, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: April 2024
• Source: The Cleveland Clinic
• Contact: Jennifer Baldwin
• Phone: 216.390.5833
• Email: baldwij[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 92
• Est. completion date: December 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Elbow Pain

Intervention

Drug:
• Diclofenac
50mg every 8hours as needed for pain
• Tramadol
50mg every 8hours as needed for pain

Locations

Country	Name	City	State
United States	The Cleveland Clinic Ohio	Avon	Ohio
United States	The Cleveland Clinic Florida	Coral Springs	Florida

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of pills taken	The number of total Tramadol pills taken per patient between the control (Tramadol + Diclofenac rescue) vs experimental (Diclofenac + Tramadol rescue) groups at two weeks.	10 days
Secondary	Non narcotic use	The percentage of patients randomized to Diclofenac that do not use any narcotic (Tramadol) rescue medication	10 days