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

Arthroscopic Knee Surgery Clinical Trial

Official title:

Optimal Dose of Spinal Mepivacaine Combined With Fentanyl For Knee Arthroscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01701102
• Other study ID #: 11140
• Status: Completed
• Phase: N/A
• First received: January 4, 2012
• Last updated: February 11, 2016
• Start date: December 2011
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthroscopic Knee Surgery

Intervention

Procedure:
• Mepivacaine plus fentanyl
Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time From Spinal Administration to Block Regression to the S1 Dermatome in Post-Anesthesia Care Unit (PACU)	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.	No