Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06373978
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-04-01
Brief Title:
NonNarcotic Pain Control in Percutaneous Needle Tenotomy of Elbow
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
A Randomized Controlled Trial Alternative Post Procedural Analgesia With NSAIDs vs Opioids in Percutaneous Needle Tenotomy of Elbow
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None