Study to Find Optimal Dose of Local Spinal Anesthetic (Mepivacaine) Combined With Narcotic (Fentanyl) For Knee Surgery

March 9, 2016 updated by: Hospital for Special Surgery, New York

Optimal Dose of Spinal Mepivacaine Combined With Fentanyl For Knee Arthroscopy

Prolonged motor block and delayed ability to walk are limitations of spinal anesthesia in ambulatory (same-day) surgery. This can be improved by lowering the dose of local anesthetic (a medication that, when injected around nerves, blocks nerve conduction, resulting in numbness and weakness) used in the spine, but too low a dose can result in an incomplete block (inadequate anesthesia) in some patients. There is evidence that adding a low dose of fentanyl, a narcotic, to mepivacaine enhances the anesthetic effect. The purpose of this study is to determine the lowest dose of mepivacaine, a local anesthetic, when combined with fentanyl, for which spinal anesthesia is adequate for ambulatory knee arthroscopy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Hospital for Special Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects aged 18-60
  • Patients scheduled for "simple" knee arthroscopies, including meniscectomy, debridement, and plica.

Exclusion Criteria:

  • Subjects aged <18 or >60
  • Subjects greater than 190 cm in height
  • Patients scheduled for ligament reconstruction or surgery involving bone
  • Daily use of narcotics for greater than one week pre-op

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Mepivacaine 37.5 mg
Procedure: Mepivacaine
Mepivacaine 37.5 mg
Active Comparator: Mepivacaine 30 mg plus fentanyl 10 µg
Procedure: Mepivacaine (30 mg) plus fentanyl
Mepivacaine (30 mg) and fentanyl (10 µg)
Active Comparator: Mepivacaine 27 mg plus fentanyl 10 µg
Procedure: Mepivacaine (27 mg) plus fentanyl
Mepivacaine (27 mg) and fentanyl (10 µg)
Active Comparator: Mepivacaine 24 mg plus fentanyl 10 µg
Procedure: Mepivacaine (24 mg) plus fentanyl
Mepivacaine (24 mg) and fentanyl (10 µg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time From Spinal Administration to Block Regression to the S1 Dermatome in Post-Anesthesia Care Unit (PACU)
Time Frame: Participants will be followed for the duration of their recovery after surgery in the post-anesthesia care unit (PACU), an expected average of 2-4 hours.
The time frame of the study for each patient only covers the period between time of surgery and time of discharge from the hospital, which is on the same day as the day of surgery
Participants will be followed for the duration of their recovery after surgery in the post-anesthesia care unit (PACU), an expected average of 2-4 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital for Special Surgery, New York

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

January 4, 2012

First Submitted That Met QC Criteria

October 3, 2012

First Posted (Estimate)

October 4, 2012

Study Record Updates

Last Update Posted (Estimate)

April 5, 2016

Last Update Submitted That Met QC Criteria

March 9, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11140

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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