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

NCT01701102 | Completed Results

• 1 other identifier: 11140
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Arthroscopic Knee Surgery

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (4)

Mepivacaine 37.5 mg

ACTIVE COMPARATOR

Procedure: Mepivacaine

Mepivacaine 30 mg plus fentanyl 10 µg

ACTIVE COMPARATOR

Procedure: Mepivacaine (30 mg) plus fentanyl

Mepivacaine 27 mg plus fentanyl 10 µg

ACTIVE COMPARATOR

Procedure: Mepivacaine (27 mg) plus fentanyl

Mepivacaine 24 mg plus fentanyl 10 µg

ACTIVE COMPARATOR

Procedure: Mepivacaine (24 mg) plus fentanyl

Interventions

Mepivacaine (24 mg) plus fentanyl PROCEDURE

Mepivacaine (24 mg) and fentanyl (10 µg)

Mepivacaine 24 mg plus fentanyl 10 µg

Mepivacaine (27 mg) plus fentanyl PROCEDURE

Mepivacaine (27 mg) and fentanyl (10 µg)

Mepivacaine 27 mg plus fentanyl 10 µg

Mepivacaine (30 mg) plus fentanyl PROCEDURE

Mepivacaine (30 mg) and fentanyl (10 µg)

Mepivacaine 30 mg plus fentanyl 10 µg

Mepivacaine PROCEDURE

Mepivacaine 37.5 mg

Mepivacaine 37.5 mg

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Interventions

Mepivacaine; Fentanyl

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Jennifer Cheng
• Organization: Hospital for Special Surgery

chengj@hss.edu

212-774-7377

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2012
• First Posted: October 4, 2012
• Study Start: December 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: December 1, 2013
• Last Updated: April 5, 2016
• Results First Posted: March 10, 2016

Record last verified: 2016-03

Locations

US (1)