The Influence of a Bupivacaine Digital Nerve Block Using Rev G.

Patients Undergoing Spine Surgery Clinical Trial

Official title:

The Influence of a Bupivacaine Digital Nerve Block With the New Continuous Sensor (Rev G) on the Accuracy of SpHb Monitoring.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01750554
• Other study ID #: 10-00524D
• Status: Completed
• Phase: N/A
• First received: December 10, 2012
• Last updated: April 9, 2015
• Start date: December 2012
• Est. completion date: July 2013

Study information

• Verified date: April 2015
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The investigators are proposing to continue investigation to improve the accuracy of the SpHb (continuous hemoglobin monitoring device) by administering an intermediate acting digital nerve block in the finger connected to the SpHb, specifically bupivacaine 0.25% in patients undergoing spine surgery. Bupivacaine is FDA approved and in routine use.

Description:

Patients undergoing spine surgery will be randomized to receive (or not) the bupivacaine digital block on the finger attached to the new limited release version of the hemoglobin sensor, RevG. The SpHb reading will be compared to a blood hemoglobin level analyzed in the UCSF Clinical Laboratories.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Male or female 18 years of age or older

• American Society of Anesthesiologists classification 1, 2 or 3

• Scheduled to undergo spine or hip surgery

Exclusion Criteria:

• Pregnant or nursing

• Patients who in the study investigators clinical judgement would not be suitable

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Patients Undergoing Spine Surgery

Intervention

Other:
• intermediate-acting digital nerve block
non-therapeutic Bupivacaine digital nerve block to assess effect on accuracy of diagnostic readings

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SpHb (continuous hemoglobin monitor reading) minus tHb (clinical laboratory determined hemoglobin value).	Use of a longer acting local anesthetic (bupivacaine) for the digital nerve block will result in SpHb (the non-invasive hemoglobin device) being sufficiently accurate for blood transfusion decisions(= 1.0 g/dL difference); To assess if using an intermediate-acting digital nerve block will improve the accuracy of the SpHb readings when compared to a blood hemoglobin level analyzed in the UCSF Clinical Laboratories intermittently during the patient's surgery.	Intermittent (about hourly) hemoglobin checks throughout the surgery.	No