CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 23 enrolled
Drug / intervention
Digital nerve block with bupivacainedrug
Likely dose
Digital nerve block with bupivacaine 2 mlfrom record
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Search/NCT02908412
NCT02908412Phase 4Completed

Evaluating and Comparing the Accuracy of Non-invasive Hemoglobin Monitoring by Spectrophotometry With and Without Digital Nerve Block in Patients Undergoing Spinal Surgery in Sina Hospital During 2016-2017

Tehran University of Medical Sciences·interventional·Posted Sep 21, 2016·Updated Apr 20, 2018

In Brief

A Phase 4 clinical trial evaluating Digital nerve block with bupivacaine for Blood Loss, Surgical. Completed, enrolled 23 participants across 1 site.

Detailed Summary

The decision to transfuse or not to transfuse blood products is one of the main issues in patients undergoing surgery. The standard laboratory method of hemoglobin assessment is time-consuming, gives intermittent data, and requires venipuncture which is invasive and painful. In the past decade, the use of non-invasive and faster methods, which allow physicians to measure hemoglobin levels at the patient's bedside, have become widespread. One of the tools that make this possible is Spectrophotometric Hemoglobin. However, one of the main concerns regarding this method is its accuracy. Since the accuracy of this assessment depends on the extent of perfusion of the organ on which the probe is placed, use of digital nerve blocks proposed to increase its accuracy. This study aims to evaluate the effects of digital nerve block (with bupivacaine) on the accuracy of non-invasive hemoglobin monitoring by spectrophotometry in patients undergoing spinal surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIran

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 21, 2016
Enrollment StartJan 4, 2017
Primary CompletionOct 1, 2017
Study CompletionJan 1, 2018
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 9.8 years ago

Interventions

Digital nerve block with bupivacainedrug

The aim of the study, the way it will be conducted, and the complications and possible risks are explained to them. written informed consent is obtained from them. Then, after induction of anaesthesia, an arterial line will be inserted in order to monitor blood pressure and to take blood samples. During the surgery, two rainbow adult ReSposable sensors will be attached to the third or fourth fingers of both hands, and each of sensors will be attached to a monitor. Patients will be randomly assigned to two groups: group A will receive DNB in left hand and group B will receive DNB in right hand. DNB will be performed by injecting 2 ml of 0.25% bupivacaine at the base of medial and lateral sides of the finger attached to the sensor (1 ml on each side of the base).