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

Phase 4

Completed

• Conditions: Onset and Duration of a Digital Nerve Block
• Interventions: Drug: Bupivacaine Digital Block; Drug: Lidocaine Digital Nerve Block

• Registration Number: NCT01508832
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-09
• Study First Submitted QC: 2012-01-11
• Study First Posted: 2012-01-12
• Primary Completion: 2013-03
• Results First Submitted: 2013-05-23
• Results First Submitted QC: 2013-08-16
• Results First Posted: 2013-08-19
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-14
• Last Update Posted: 2020-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Non-smokers

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Bupivacaine	Bupivacaine Digital Block	Bupivacaine 0.25% Digital Block (2 cc)
Lidocaine	Lidocaine Digital Nerve Block	Lidocaine 1% Digital Nerve Block (2 cc)

Primary Outcome Measures

Name	Time	Method
The Change in the Average Finger Temperature From Baseline to Post-intervention.	30 minutes prior and 240 minutes post intervention.

Trial Locations

Locations (1)

University of California San Francisco; 🇺🇸 San Francisco, California, United States