Effect of Neurostimulator Usage on Block Success

Effect of Neurostimulator Usage on Block Success in Costoclavicular Block: a Randomized Controlled Trial

The need of a neurostimulator for a successful nerve block was questioned in different block types after ultrasound has become standard. The aim of this clinical study was to determine the effect of neurostimulator use on block success in costoclavicular block

Study Overview

• Status: Completed
• Conditions: PATIENTS WITH UPPER EXTREMITY SURGERY
• Intervention / Treatment: Drug: fentanyl will be added; Procedure: general anesthesia

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Gazoosmanpasa Education and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Class I, II and III of American Society of Anesthesiologists (ASA) classification
• being between 18 and 80 years of age,
• body mass index (BMI) between 18 and 35 kg/m2

Exclusion Criteria:

• Patients who did not give consent,
• were above ASA III,
• pregnant,
• had a neuromuscular disease,
• bleeding diathesis,
• a local anesthetic allergy,
• an infection in the area where nerve block would be applied, and
• had previously operated from the infraclavicular fossa were not included in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group USP; The group using ultrasound and injection pressure manometer was named USP	Drug: fentanyl will be added; If adequate anagesia is not provided with the block, 1 microgram/kg of fentanyl will be added; Procedure: general anesthesia; If adequate anagesia is not provided with the block, general anesthesia will be administered.
Experimental: Group USPN; The group using ultrasound , injection pressure manometer , and neurostimulator was named USPN	Drug: fentanyl will be added; If adequate anagesia is not provided with the block, 1 microgram/kg of fentanyl will be added; Procedure: general anesthesia; If adequate anagesia is not provided with the block, general anesthesia will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The block success rate (ratio of successful blocks to all blocks)	The block was considered unsuccessful in case of analgesic need during the surgery or transition to general anesthesia, otherwise, these patients were included in the successful block group.	during procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Block application time	THE TIME BETWEEN THE NEEDLE ENTRY THROUGH THE SKIN AND THE OUTPUT OF THE NEEDLE AFTER LOCAL ANESTHETICS IS GIVEN, WAS RECORDED AS THE APPLICATION TIME	30 minutes
time to readiness for surgery	Sensory and motor block levels were evaluated in the median, radial, ulnar and musculocutaneous nerve traces at 5-minute intervals for 30 minutes. An ice pack was used for sensory block evaluation. It was scored as follows; 0: completely felt; 1: has a sense of touch; no cold; 2: no sense of touch. Lateral surface of the forearm for the musculocutaneous nerve, the surface of the thumb facing the palm for the median nerve, the inner surface of the 5th finger for the ulnar nerve, and the posterior surface of the hand for the radial nerve were used for sensorial evaluation. Motor block was scored as follows; 0: full motion; 1: paresis; 2: complete block. Elbow flexion for the musculocutaneous nerve, thumb opposition for the median nerve, 5th finger abduction for the ulnar nerve, and wrist extension for the radial nerve were used to evaluate motor block. The block was considered successful if the total score was 14 or higher, with a total sensory score of at least 7.	30 minutes
number of needle passes	. The number of needle passes was calculated by adding each needle advancement exceeding 10 mm to the first needle insertion.	30 minutes

Collaborators and Investigators

• Sponsor: Gaziosmanpasa Research and Education Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): February 1, 2020
• Study Completion (Actual): January 2, 2021

Study Registration Dates

• First Submitted: December 20, 2022
• First Submitted That Met QC Criteria: January 20, 2023
• First Posted (Actual): January 31, 2023

Study Record Updates

• Last Update Posted (Actual): January 31, 2023
• Last Update Submitted That Met QC Criteria: January 20, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Brachial Plexus Block; Nerve Block; Ultrasonography
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl
• Other Study ID Numbers: Neurostimulator Usage

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No