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NCT03693404 · ClinicalTrials.gov registry record · Phase 4

Effects of a Surgical Site Injection on Pain Scores and Narcotic Use After Orthopaedic Trauma Surgery

A Phase 4 study, sponsored by NYU Langone Health.

Completed
Registry status
Phase 4
Development phase
190
Enrollment target

NCT03693404: Completed Phase 4 study, sponsored by NYU Langone Health.

NCT03693404 is a Phase 4 study that has completed, run by NYU Langone Health. The registered enrollment target is 190 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03693404, a Phase 4 study, has completed, sponsored by NYU Langone Health.

COMPLETED
Registry status
Phase 4
Development phase
190 participants
Enrollment target

Study Summary

This is a phase I, randomized, single-blind, placebo-controlled, single-center study of the effects of surgical site injection on pain and narcotic utilization in participants who undergo surgery for lower extremity fractures. 200 participants with lower extremity fractures who are admitted for operative fixation will be included in the study. Participants will be randomized to receive either a pain cocktail injection around the fracture site and surrounding tissues or control (no injection). An analysis of pain scores, rehabilitation progress, length of stay, narcotic utilization, and satisfaction scores will be performed.

Primary Outcome

Number of mgs taken of oral morphine

Interventions

  • DRUG Marcaine, Duramorph , ketorolac
  • DRUG Bupivacaine (Marcaine)
  • DRUG General Anesthetics

Trial Details

FieldValue
Enrollment Target 190 participants
Start Date 2018-12-01
Est. Completion 2021-06-05
Phase Phase 4
NYU Langone Health

1,164 total trials

What the finished NCT03693404 record still lists

NCT03693404 is an interventional study that assigns participants to a tested intervention. The registered 190 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (63% lower).

The record links to 0 conditions, and to 3 interventions - of which Marcaine, Duramorph , ketorolac is the first listed.

NCT03693404 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03693404 about?

NCT03693404 is a clinical study titled "Effects of a Surgical Site Injection on Pain Scores and Narcotic Use After Orthopaedic Trauma Surgery". This is a phase I, randomized, single-blind, placebo-controlled, single-center study of the effects of surgical site injection on pain and narcotic utilization in participants who undergo surgery for lower extremity fractures. 200 participants with lower extremity fractures who are admitted for oper...

What is the current status of trial NCT03693404?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 190 participants. The study started on 2018-12-01. Estimated completion is 2021-06-05.

What interventions are being tested in trial NCT03693404?

The interventions under investigation include: Marcaine, Duramorph , ketorolac (DRUG), Bupivacaine (Marcaine) (DRUG), General Anesthetics (DRUG).

Who is sponsoring clinical trial NCT03693404?

This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03693404's enrollment target sits among peer trials

190 453rd of 2000 higher than 1,545 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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 NCT03693404, the US trial registry maintained by the National Library of Medicine. NCT03693404 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.