Effect of Neurostimulator Usage on Block Success

Study Overview
=================
Brief Summary
-----------------
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

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

Conditions
-----------------
PATIENTS WITH UPPER EXTREMITY SURGERY

Intervention / Treatment
-----------------
* Drug: fentanyl will be added
* Procedure: general anesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Brachial Plexus Block; Nerve Block; Ultrasonography