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

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 113 other Pain, Postoperative trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Patient-reported post-operative VAS pain (on a scale of 0-10 with zero implying no pain and 10 indicating severe pain), measured post operatively, in 8-hour increments, for a total of 96 hours post-surgery, Patients will be prompted via text message to provide VAS pain every 8 hours. If a response text message is not received, a phone call will be made to obtain the information. Patients who do not have a smart phone will receive a phone call or keep a personal log of VAS pain.

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
Indiana University

890 total trials

What the finished NCT03822182 record still lists

NCT03822182 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 272-participant average among 113 other Pain, Postoperative trials with a reported enrollment target (71% lower).

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 a single indexed study location in 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.

Similar trials for Pain, Postoperative

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03822182's enrollment target sits among peer trials

78 62nd of 113 higher than 51 of 113 other Pain, Postoperative trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Pain, Postoperative trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03822182, the US trial registry maintained by the National Library of Medicine. NCT03822182 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.