Brachial Plexus Block vs. General Anesthesia for Anesthesia Anxiety Before Orthopedic Upper Extremity Surgery

NCT ID: NCT05476198

Last Updated: 2022-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-05

Study Completion Date

2021-08-09

Brief Summary

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Surgical procedures and anesthesia applications are situations in which people do not feel safe due to the current vital risks. Anxiety is a natural reaction that occurs in such situations, it manifests itself with worry and fear. Increased anxiety before surgery is associated with pathophysiological responses such as hypertension and dysrhythmia. Intense preoperative anxiety can increase morbidity, the need for anesthetic medication, and postoperative analgesia.

For this reason, many questionnaire studies have been conducted to measure the degree of preoperative anxiety and to reveal its causes. The Amsterdam Preoperative Anxiety and Information Scale (APAIS) test has two parts that measure anxiety and the need for information about anesthesia and surgery. The APAIS-A (anxiety) part is the test that measures strain and shows whether the patient has anxiety about anesthesia or surgery. The APAIS-I (information) part estimates whether the person needs information.

In the literature, the effects of general and spinal anesthesia techniques on preoperative anxiety levels have been compared for some specific surgical methods such as c-sections and perianal region surgeries. However, no study has been reported between peripheral nerve block and general anesthesia techniques.

This study aimed to determine the effects of regional and general anesthesia methods on preoperative anxiety levels and the factors affecting these scores in patients who will undergo upper extremity surgery.

Detailed Description

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146 patients (ASA I-II-III) aged 18-75 years who were to undergo orthopedic upper extremity surgery were randomized and divided into two groups. 26 patients were dropout for different reasons (60 patients in each of the BPB block and general anesthesia groups). One of the brachial plexus blocks was performed according to the level to be operated on to the BPB group, and general anesthesia was performed on the GA group.

Preoperative anxiety of the patients was measured using the APAIS test. The patients' preoperative anxiety score was the primary outcome measure. Postoperative numerical rating scale values were a secondary outcome measure.

Conditions

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Orthopedic Disorder Anxiety Upper Extremity Injury Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Group BPB

The investigators performed a brachial plexus block on that patient group for preoperative anxiety

Group Type ACTIVE_COMPARATOR

Brachial plexus block

Intervention Type PROCEDURE

The effect of brachial plexus block method on preoperative anxiety levels in patients who will undergo orthopedic upper extremity surgery.

Group GA

The investigators performed general anesthesia on that patient group for preoperative anxiety

Group Type ACTIVE_COMPARATOR

General anesthesia

Intervention Type PROCEDURE

The effect of general anesthesia method on preoperative anxiety levels in patients who will undergo orthopedic upper extremity surgery.

Interventions

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Brachial plexus block

The effect of brachial plexus block method on preoperative anxiety levels in patients who will undergo orthopedic upper extremity surgery.

Intervention Type PROCEDURE

General anesthesia

The effect of general anesthesia method on preoperative anxiety levels in patients who will undergo orthopedic upper extremity surgery.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Ages of 18-75
* ASA I-III
* Patients who will undergo orthopedic upper extremity surgery

Exclusion Criteria

* Clinically known local anesthetic allergy
* Morbid obesity (body mass index\> 35 kg m2)
* Clinically diagnosis of opioid, alcohol and substance dependence
* Clinically diagnosis of psychiatric disease
* Coagulopathy
* Patients with ASA IV-V
* Illiterate patients
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bakirkoy Dr. Sadi Konuk Research and Training Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Gokhan Sertcakacilar, MD

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Istanbul, Bakirkoy, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Chen YK, Soens MA, Kovacheva VP. Less stress, better success: a scoping review on the effects of anxiety on anesthetic and analgesic consumption. J Anesth. 2022 Aug;36(4):532-553. doi: 10.1007/s00540-022-03081-4. Epub 2022 Jul 2.

Reference Type BACKGROUND
PMID: 35779126 (View on PubMed)

Ozturk Inal Z, Gorkem U, Inal HA. Effects of preoperative anxiety on postcesarean delivery pain and analgesic consumption: general versus spinal anesthesia. J Matern Fetal Neonatal Med. 2020 Jan;33(2):191-197. doi: 10.1080/14767058.2018.1487948. Epub 2018 Jul 18.

Reference Type BACKGROUND
PMID: 29886798 (View on PubMed)

Maheshwari D, Ismail S. Preoperative anxiety in patients selecting either general or regional anesthesia for elective cesarean section. J Anaesthesiol Clin Pharmacol. 2015 Apr-Jun;31(2):196-200. doi: 10.4103/0970-9185.155148.

Reference Type BACKGROUND
PMID: 25948900 (View on PubMed)

Celik F, Edipoglu IS. Evaluation of preoperative anxiety and fear of anesthesia using APAIS score. Eur J Med Res. 2018 Sep 11;23(1):41. doi: 10.1186/s40001-018-0339-4.

Reference Type BACKGROUND
PMID: 30205837 (View on PubMed)

Other Identifiers

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2020-36

Identifier Type: -

Identifier Source: org_study_id

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