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NCT01586806 · ClinicalTrials.gov registry record · Phase 4

Comparing Subsartorial Saphenous Nerve Blocks With and Without Dexamethasone for Anterior Cruciate Ligament Reconstruction

A Phase 4 study of Anterior Cruciate Ligament Reconstruction and Regional Anesthesia, Saphenous Nerve Block, sponsored by Hospital for Special Surgery, New York.

Completed
Registry status
Phase 4
Development phase
195
Enrollment target
1
Study location

NCT01586806 is a Phase 4 study of Anterior Cruciate Ligament Reconstruction and Regional Anesthesia, Saphenous Nerve Block that has completed, run by Hospital for Special Surgery, New York. The registered enrollment target is 195 participants, below the 276-participant average among 11 other Anterior Cruciate Ligament Reconstruction trials with a reported enrollment target (29% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01586806, a Phase 4 study of Anterior Cruciate Ligament Reconstruction and Regional Anesthesia, Saphenous Nerve Block, has completed, sponsored by Hospital for Special Surgery, New York.

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

Study Summary

For patients undergoing Anterior Cruciate Ligament reconstruction surgery, the postoperative period can be a painful experience without adequate pain management. Hence the investigators propose a randomized controlled clinical study, investigating prolonged saphenous nerve blocks. Patients will be randomized to receive saphenous nerve blocks with or without dexamethasone, a corticosteroid used to prolong analgesia. Depending on the randomized treatment assignment, patients may receive one of the following: 1. 13 ml of 0.5% bupivacaine, a local anesthetic (no dexamethasone); 2. 13 ml of 0.5% bupivacaine mixed with 1 mg of dexamethasone; 3. 13 ml of 0.5% bupivacaine mixed with 4 mg of dexamethasone. Patients will be followed postoperatively. Following admission to the recovery room, data collectors will ask patients to rate their pain on a scale of 0-10 until discharge. Data collectors will also record patient satisfaction, pain medication use and any side effects experienced (i.e. nausea and vomiting). Patients will then be contacted on postoperative days 1, 2 and 14 and asked questions about their general well-being.

Conditions Studied

Anterior Cruciate Ligament Reconstruction Regional Anesthesia, Saphenous Nerve Block

Interventions

  • DRUG Bupivacaine Only
  • DRUG Bupivacaine with 1 mg of Dexamethasone
  • DRUG Bupivacaine with 4 mg of Dexamethasone

Study Locations (1)

New York

  • Hospital for Special Surgery - New York

Trial Details

FieldValue
Enrollment Target 195 participants
Start Date 2012-07
Est. Completion 2014-12
Phase Phase 4

Sponsor

Hospital for Special Surgery, New York

194 total trials

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What the Registry Record Tells You About NCT01586806

The ClinicalTrials.gov registry entry for NCT01586806 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 195 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 276-participant average among 11 other Anterior Cruciate Ligament Reconstruction trials with a reported enrollment target (29% lower). The listed sponsor is Hospital for Special Surgery, New York, which has 194 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Anterior Cruciate Ligament Reconstruction appearing as the primary indexed condition, and to 3 interventions - of which Bupivacaine Only is the first listed.

NCT01586806 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT01586806 about?

NCT01586806 is a clinical study titled "Comparing Subsartorial Saphenous Nerve Blocks With and Without Dexamethasone for Anterior Cruciate Ligament Reconstruction". For patients undergoing Anterior Cruciate Ligament reconstruction surgery, the postoperative period can be a painful experience without adequate pain management. Hence the investigators propose a randomized controlled clinical study, investigating prolonged saphenous nerve blocks. Patients will be r...

What is the current status of trial NCT01586806?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 195 participants. The study started on 2012-07. Estimated completion is 2014-12.

What conditions does trial NCT01586806 study?

This clinical trial studies the following conditions: Anterior Cruciate Ligament Reconstruction, Regional Anesthesia, Saphenous Nerve Block.

What interventions are being tested in trial NCT01586806?

The interventions under investigation include: Bupivacaine Only (DRUG), Bupivacaine with 1 mg of Dexamethasone (DRUG), Bupivacaine with 4 mg of Dexamethasone (DRUG).

Who is sponsoring clinical trial NCT01586806?

This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01586806 being conducted?

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

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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.