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Completed

NCT Number: NCT01701102

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

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.

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Key information

Conditions

Arthroscopic Knee Surgery

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital for Special Surgery

New York, 10021, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mepivacaine (24 mg) plus fentanyl

Procedure

Mepivacaine (24 mg) and fentanyl (10 µg)

Mepivacaine (27 mg) plus fentanyl

Procedure

Mepivacaine (27 mg) and fentanyl (10 µg)

Mepivacaine (30 mg) plus fentanyl

Procedure

Mepivacaine (30 mg) and fentanyl (10 µg)

Mepivacaine

Procedure

Mepivacaine 37.5 mg

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study title

Optimal Dose of Spinal Mepivacaine Combined With Fentanyl For Knee Arthroscopy

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Oct 4, 2012
Registry last updated
Apr 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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