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

NCT01586806 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 195

Last updated 2016-11-28

Study results available
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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

  • Anterior Cruciate Ligament Reconstruction
  • Regional Anesthesia, Saphenous Nerve Block

Interventions

DRUG

Bupivacaine Only

This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).

DRUG

Bupivacaine with 1 mg of Dexamethasone

This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.

DRUG

Bupivacaine with 4 mg of Dexamethasone

This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.

Sponsors & Collaborators

  • Hospital for Special Surgery, New York

    lead OTHER

Principal Investigators

  • Mary F. Chisholm, MD · Hospital for Special Surgery, New York

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2014-11-30
Completion
2014-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01586806 on ClinicalTrials.gov