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NCT04415931 · ClinicalTrials.gov registry record · NA
Local Infiltration Analgesia Vs. Interscalene Block in Total Shoulder Arthorplasty
A NA study of Shoulder Osteoarthritis and Cuff Tear Arthropathy, sponsored by University of Missouri-Columbia.
- Completed
- Registry status
- NA
- Development phase
- 78
- Enrollment target
- 1
- Study location
NCT04415931 is a NA study of Shoulder Osteoarthritis and Cuff Tear Arthropathy that has completed, run by University of Missouri-Columbia. The registered enrollment target is 78 participants, below the 196-participant average among 9 other Shoulder Osteoarthritis trials with a reported enrollment target (60% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04415931, a NA study of Shoulder Osteoarthritis and Cuff Tear Arthropathy, has completed, sponsored by University of Missouri-Columbia.
- COMPLETED
- Registry status
- NA
- Development phase
- 78 participants
- Enrollment target
- 1
- Study location
Study Summary
Pain management following total shoulder arthroplasty is an important factor in determining patient outcomes and satisfaction. Interscalene brachial plexus blockade has been used successfully to minimize pain in the acute post-operative period. While shown to be effective, interscalene blockade has known complications. In addition, interscalene block has been shown to be significantly more expensive when compared to local anesthesia infiltration. Local anesthetics such as bupivacaine have long been used to assist in post-operative anesthesia. Recent reports have demonstrated local infiltration of liposomal bupivacaine to be similar to interscalene block in regards to patient analgesia even in the first 24 hours post operatively, with the added benefit of lower complications and costs. While most reports examine the efficacy of local infiltration with liposomal bupivacaine in the shoulder, other total joint literature has been positive regarding the use of local infiltration analgesic mixture for improved post-operative analgesia using a multi-modal approach to infiltrative analgesia. Despite these reports, the role and efficacy of local infiltration analgesia in shoulder arthroplasty is lacking. The purpose of the proposed study is to determine the efficacy and safety of local infiltration analgesia in shoulder arthroplasty in comparison to interscalene block through a randomized prospective clinical trial. Our hypothesis is that local infiltration analgesia will lead to postoperative pain scores, opiate consumption, and complication rate that are not significantly different from interscalene block.
Conditions Studied
Interventions
- PROCEDURE Local infiltration analgesia
- PROCEDURE Interscalene block
Study Locations (1)
Missouri
- University of Missouri - Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2020-08-15 |
| Est. Completion | 2022-03-13 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04415931
The ClinicalTrials.gov registry entry for NCT04415931 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 78 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 196-participant average among 9 other Shoulder Osteoarthritis trials with a reported enrollment target (60% lower). The listed sponsor is University of Missouri-Columbia, which has 291 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Shoulder Osteoarthritis appearing as the primary indexed condition, and to 2 interventions - of which Local infiltration analgesia is the first listed.
NCT04415931 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT04415931 about?
NCT04415931 is a clinical study titled "Local Infiltration Analgesia Vs. Interscalene Block in Total Shoulder Arthorplasty". Pain management following total shoulder arthroplasty is an important factor in determining patient outcomes and satisfaction. Interscalene brachial plexus blockade has been used successfully to minimize pain in the acute post-operative period. While shown to be effective, interscalene blockade has ...
What is the current status of trial NCT04415931?
This trial is currently completed. It is a NA study. The enrollment target is 78 participants. The study started on 2020-08-15. Estimated completion is 2022-03-13.
What conditions does trial NCT04415931 study?
This clinical trial studies the following conditions: Shoulder Osteoarthritis, Cuff Tear Arthropathy, Massive Rotator Cuff Tear.
What interventions are being tested in trial NCT04415931?
The interventions under investigation include: Local infiltration analgesia (PROCEDURE), Interscalene block (PROCEDURE).
Who is sponsoring clinical trial NCT04415931?
This trial is sponsored by University of Missouri-Columbia, which has 291 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04415931 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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