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OpenTrials
Completed

NCT Number: NCT01508832

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

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.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of California San Francisco

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Lidocaine Digital Nerve Block

Drug

Lidocaine 1% Digital Nerve Block (2 cc

Bupivacaine Digital Block

Drug

Bupivacaine 0.25% Digital Block (2 cc)

Primary outcomes

  1. The Change in the Average Finger Temperature From Baseline to Post-intervention.

    Time frame: 30 minutes prior and 240 minutes post intervention.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
First posted
Jan 12, 2012
Registry last updated
Jan 30, 2020

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.