Determination of the Duration of Action of a Lidocaine and a Bupivacaine Digital Nerve Block in Human Volunteers

NCT ID: NCT01508832

Last Updated: 2020-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31

Brief Summary

The duration of the autonomic (sympathetic) block will last longer than the sensory block. The duration of the increased perfusion index will last longer than either the sympathetic or sensory block.

Detailed Description

The Masimo SpHb™ (SpHb) is a device used to monitor the blood hemoglobin level via a sticky sensor connected to a finger. Our results from 2 recent studies undertaken with this device concluded: 1) that it is not always accurate when the finger is cold such as during surgical blood loss, and 2) a local nerve block to the finger improved the finger temperature and the accuracy of the device.

Our purpose is to investigate the duration of effect of two local nerve blocking drugs (lidocaine and bupivacaine - both FDA approved drugs in routine use) in a finger on each hand. Having a better understanding of how long the nerve block lasts could help determine when an additional block might be necessary to maintain the accuracy of the device during surgical blood loss.

We previously listed the primary outcome for this study as the time until return to baseline finger temperature. However, in blinded looks at the data it became clear that defining time until return to baseline from the serial temperature measurements in an objective fashion would be extremely difficult and potentially controversial. We have modified the primary outcome to be the change in the average temperature from baseline to post-intervention.

Conditions

Onset and Duration of a Digital Nerve Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Lidocaine

Lidocaine 1% Digital Nerve Block (2 cc)

Group Type: ACTIVE_COMPARATOR

Lidocaine Digital Nerve Block

Intervention Type: DRUG

Lidocaine 1% Digital Nerve Block (2 cc

Bupivacaine

Bupivacaine 0.25% Digital Block (2 cc)

Group Type: ACTIVE_COMPARATOR

Bupivacaine Digital Block

Intervention Type: DRUG

Bupivacaine 0.25% Digital Block (2 cc)

Interventions

Lidocaine Digital Nerve Block

Lidocaine 1% Digital Nerve Block (2 cc

Intervention Type: DRUG

Bupivacaine Digital Block

Bupivacaine 0.25% Digital Block (2 cc)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Non-smokers

Exclusion Criteria

• History of allergic response to local anesthetics
• BMI >25
• Pregnant of nursing
• Current smokers or past smokers of > 1 pack year history
• Neurological deficit and/or injury in the upper extremities
• Current respiratory infection
• Per investigator judgement, would not be suitable for study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald Miller, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

11-06121

Identifier Type: -

Identifier Source: org_study_id