Non-invasive Perioperative Hb Monitoring in Spinal Surgery

NCT02908412 | Completed Phase 4

• 1 other identifier: IR.TUMS.VCR.REC.1395.110
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Nerve Block; Spectrophotometry; Bupivacaine; Spinal Surgery; Blood Loss, Surgical

Outcome Measures

Primary Outcomes (1)

• accuracy of SpHb

  in each patient, Sphb values will be documented for both hands. Also, the arterial blood sample (lab Hb) will be sent to the laboratory. The difference between two measure in each hand (with or without DNB) shows the accuracy of Sphb for each hand.

  At the start of the operation, once every 1.5 hours during the operation till its end

Secondary Outcomes (2)

• Perfusion index (PI)

  At the start of the operation, once every 1.5 hours during the operation till its end

• Pleth Variability Index (PVI)

  At the start of the operation, once every 1.5 hours during the operation till its end

Study Arms (2)

Digital nerve block in left hand

EXPERIMENTAL

Patients in this group will receive DNB in left 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).

Drug: Digital nerve block with bupivacaine

Digital nerve block in right hand

EXPERIMENTAL

Patients in this group 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).

Drug: Digital nerve block with bupivacaine

Interventions

Digital nerve block with bupivacaine DRUG

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).

Digital nerve block in left hand; Digital nerve block in right hand

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead
• Sina Trauma and Surgery Research Center: collaborator

Study Sites (1)

Sina Hospital

Tehran, Tehtan, Iran

Location

Related Publications (11)

• Barker SJ, Shander A, Ramsay MA. Continuous Noninvasive Hemoglobin Monitoring: A Measured Response to a Critical Review. Anesth Analg. 2016 Feb;122(2):565-72. doi: 10.1213/ANE.0000000000000605.

  PMID: 25746056 BACKGROUND

• Lamhaut L, Apriotesei R, Combes X, Lejay M, Carli P, Vivien B. Comparison of the accuracy of noninvasive hemoglobin monitoring by spectrophotometry (SpHb) and HemoCue(R) with automated laboratory hemoglobin measurement. Anesthesiology. 2011 Sep;115(3):548-54. doi: 10.1097/ALN.0b013e3182270c22.

  PMID: 21716091 BACKGROUND

• Suehiro K, Joosten A, Alexander B, Cannesson M. Continuous noninvasive hemoglobin monitoring: ready for prime time? Curr Opin Crit Care. 2015 Jun;21(3):265-70. doi: 10.1097/MCC.0000000000000197.

  PMID: 25827587 BACKGROUND

• Kim SH, Lilot M, Murphy LS, Sidhu KS, Yu Z, Rinehart J, Cannesson M. Accuracy of continuous noninvasive hemoglobin monitoring: a systematic review and meta-analysis. Anesth Analg. 2014 Aug;119(2):332-346. doi: 10.1213/ANE.0000000000000272.

  PMID: 24914627 BACKGROUND

• Applegate RL 2nd, Barr SJ, Collier CE, Rook JL, Mangus DB, Allard MW. Evaluation of pulse cooximetry in patients undergoing abdominal or pelvic surgery. Anesthesiology. 2012 Jan;116(1):65-72. doi: 10.1097/ALN.0b013e31823d774f.

  PMID: 22133758 BACKGROUND

• Rice MJ, Gravenstein N, Morey TE. Noninvasive hemoglobin monitoring: how accurate is enough? Anesth Analg. 2013 Oct;117(4):902-907. doi: 10.1213/ANE.0b013e31829483fb. Epub 2013 Jul 10.

  PMID: 23842195 BACKGROUND

• Giraud B, Frasca D, Debaene B, Mimoz O. Comparison of haemoglobin measurement methods in the operating theatre. Br J Anaesth. 2013 Dec;111(6):946-54. doi: 10.1093/bja/aet252. Epub 2013 Jul 17.

  PMID: 23869108 BACKGROUND

• Park YH, Lee JH, Song HG, Byon HJ, Kim HS, Kim JT. The accuracy of noninvasive hemoglobin monitoring using the radical-7 pulse CO-Oximeter in children undergoing neurosurgery. Anesth Analg. 2012 Dec;115(6):1302-7. doi: 10.1213/ANE.0b013e31826b7e38. Epub 2012 Nov 9.

  PMID: 23144437 BACKGROUND

• Miller RD, Ward TA, Shiboski SC, Cohen NH. A comparison of three methods of hemoglobin monitoring in patients undergoing spine surgery. Anesth Analg. 2011 Apr;112(4):858-63. doi: 10.1213/ANE.0b013e31820eecd1. Epub 2011 Mar 8.

  PMID: 21385985 BACKGROUND

• Miller RD, Ward TA, McCulloch CE, Cohen NH. Does a digital regional nerve block improve the accuracy of noninvasive hemoglobin monitoring? J Anesth. 2012 Dec;26(6):845-50. doi: 10.1007/s00540-012-1452-0. Epub 2012 Aug 1.

  PMID: 22850903 BACKGROUND

• Miller RD, Ward TA, McCulloch CE, Cohen NH. A comparison of lidocaine and bupivacaine digital nerve blocks on noninvasive continuous hemoglobin monitoring in a randomized trial in volunteers. Anesth Analg. 2014 Apr;118(4):766-71. doi: 10.1213/ANE.0000000000000144.

  PMID: 24651230 BACKGROUND

MeSH Terms

Conditions

Blood Loss, Surgical

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2016
• First Posted: September 21, 2016
• Study Start: January 4, 2017
• Primary Completion: October 1, 2017
• Study Completion: January 1, 2018
• Last Updated: April 20, 2018

Record last verified: 2017-12

Locations

IR (1)