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NCT03822182 · ClinicalTrials.gov registry record · Phase 4

Single Shot Liposomal Bupivicaine in Rotator Cuff Surgery

A Phase 4 study of Pain, Postoperative and Rotator Cuff Tear, sponsored by Indiana University.

Completed
Registry status
Phase 4
Development phase
78
Enrollment target
1
Study location

NCT03822182 is a Phase 4 study of Pain, Postoperative and Rotator Cuff Tear that has completed, run by Indiana University. The registered enrollment target is 78 participants, below the 272-participant average among 108 other Pain, Postoperative trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03822182, a Phase 4 study of Pain, Postoperative and Rotator Cuff Tear, has completed, sponsored by Indiana University.

COMPLETED
Registry status
Phase 4
Development phase
78 participants
Enrollment target
1
Study location

Study Summary

This document is a protocol for a human research study. This study is to be conducted according to United States standards of Good Clinical Practice in accordance with applicable Federal regulations and institutional research policies and procedures. Liposomal bupivacaine (LB) has been shown to decrease post-operative pain and narcotic use when administered perioperatively as a local injection during arthroplasty procedures. Studies have also demonstrated that LB used in conjunction with dexamethasone may increase the duration of effectiveness of LB. This study seeks to evaluate if there is a difference in post-operative pain and narcotic use when LB is administered in an interscalene block during outpatient rotator cuff repair surgery. Furthermore, this study aims to determine if the addition of dexamethasone with LB results in a prolonged decrease in post-operative pain and a reduction in narcotic use.

Interventions

  • DRUG Dexamethasone
  • DRUG liposomal bupivicaine

Study Locations (1)

Indiana

  • American Health Network - Avon

Trial Details

FieldValue
Enrollment Target 78 participants
Start Date 2018-10-24
Est. Completion 2020-01-22
Phase Phase 4

Sponsor

Indiana University

890 total trials

What the Registry Record Tells You About NCT03822182

The ClinicalTrials.gov registry entry for NCT03822182 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 78 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 272-participant average among 108 other Pain, Postoperative trials with a reported enrollment target (71% lower). The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Pain, Postoperative appearing as the primary indexed condition, and to 2 interventions - of which Dexamethasone is the first listed.

NCT03822182 reports 1 study location spanning 1 distinct geographic area - top geographies include Indiana.

Frequently Asked Questions

What is clinical trial NCT03822182 about?

NCT03822182 is a clinical study titled "Single Shot Liposomal Bupivicaine in Rotator Cuff Surgery". This document is a protocol for a human research study. This study is to be conducted according to United States standards of Good Clinical Practice in accordance with applicable Federal regulations and institutional research policies and procedures. Liposomal bupivacaine (LB) has been shown to dec...

What is the current status of trial NCT03822182?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 78 participants. The study started on 2018-10-24. Estimated completion is 2020-01-22.

What conditions does trial NCT03822182 study?

This clinical trial studies the following conditions: Pain, Postoperative, Rotator Cuff Tear.

What interventions are being tested in trial NCT03822182?

The interventions under investigation include: Dexamethasone (DRUG), liposomal bupivicaine (DRUG).

Who is sponsoring clinical trial NCT03822182?

This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03822182 being conducted?

This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.