Is Perfusion Index an Indicator of Block Success in Ultrasound-guided Infraclavicular Brachial Plexus Block

Comparison of Block Success in Patients Undergoing Ultrasound-guided Infraclavicular Brachial Plexus Block With Bilateral Upper Extremity Perfusion Index

The infraclavicular nerve block, which is frequently preferred in upper extremity surgeries, provides additional advantages such as reduction in opioid consumption by providing analgesic effect in the postoperative period as welll. The success of peripheral nerve blocks is usually assessed by subjective feedback from the patient, and patient cooperation is needed. The aim of this study is to assess whether the perfusion index level, which can be measured noninvasively, can be a predictor of the infraclavicular block success.

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome; Perfusion Index
• Intervention / Treatment: Procedure: Infraclavicular nerve block; Procedure: Without nerve block

Detailed Description

Thirty patients who were operated on for carpal tunnel syndrome under infraclavicular brachial plexus block were included in our study. After the procedure, at 10-minute intervals, the sensory block was assessed by a pinprick test, and the motor block was assessed by the ability to flex the hand and the forearm. In addition, PI and skin temperature were measured 0-10-20-30 minutes after the block and at postoperative 2, 4, and 6 hours. 30 minutes after the measurements, the surgical procedure was allowed to begin in patients with successful block.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bakirkoy
    • Istanbul, Bakirkoy, Turkey, 34147
      • Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Ages of 18-75
• Patients who will diagnose with carpal tunnel syndrome by electroneuromyography (ENMG), and will undergo unilateral surgery under elective conditions
• ASA I-II-III patients

Exclusion Criteria:

• Patients who will refuse this method
• Neurological deficits,
• Diabetes mellitus,
• Local anesthetic allergy,
• Morbidly obese,
• Peripheral vascular disease, coronary artery disease, or coagulopathy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Blocked arm; The investigators performed an infraclavicular nerve block to the operated arm group to provide anesthesia.	Procedure: Infraclavicular nerve block; The investigators performed an infraclavicular nerve block to the operated arm group to provide anesthesia.
Active Comparator: Unblocked arm; The upper extremity without block was assigned as the control group, and a comparison was made between the two upper extremities.	Procedure: Without nerve block; The upper extremity without block was assigned as the control group, and a comparison was made between the two upper extremities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of whether perfusion index is a reliable and objective method to indicate block success	Perfusion index was measured up to 6 hours after the procedure.	6 hours postprocedurly

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determining of a cut-off value for PI and PI ratio for a successful block.	There may be changes in the cut-off value depending on the applied plexus area, local anesthesia, volume and concentration of LA and the applied assistive technique (ultrasound or nerve stimulator). For both this reason and due to the high variability in the PI values, the PI ratio was calculated to predict block success.	Up to 6 hours after the procedure

Collaborators and Investigators

• Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2014
• Primary Completion (Actual): April 15, 2014
• Study Completion (Actual): October 30, 2014

Study Registration Dates

• First Submitted: June 1, 2021
• First Submitted That Met QC Criteria: June 4, 2021
• First Posted (Actual): June 10, 2021

Study Record Updates

• Last Update Posted (Actual): June 10, 2021
• Last Update Submitted That Met QC Criteria: June 4, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Ultrasonography; Infraclavicular block; Perfusion index; Block assessment
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Carpal Tunnel Syndrome
• Other Study ID Numbers: 2014-86

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No