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Non-invasive Perioperative Hb Monitoring in Spinal Surgery

NCT02908412 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2018-04-20

No results posted yet for this study

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.

Conditions

  • Blood Loss, Surgical

Interventions

DRUG

Digital nerve block with bupivacaine

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).

Sponsors & Collaborators

  • Sina Trauma and Surgery Research Center

    collaborator OTHER

  • Tehran University of Medical Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-04
Primary Completion
2017-10-31
Completion
2018-01-31

Countries

  • Iran

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02908412 on ClinicalTrials.gov