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

Not Applicable

Completed

• Conditions: Anxiety; Orthopedic Disorder; Surgery; Upper Extremity Injury
• Interventions: Procedure: Brachial plexus block; Procedure: General anesthesia

• Registration Number: NCT05476198
• Lead Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-02-05
• Primary Completion: 2021-04-15
• Study Completion: 2021-08-09
• Status Verified: 2022-07
• Study First Submitted: 2022-07-25
• Study First Submitted QC: 2022-07-26
• Last Update Submitted: 2022-07-26
• Study First Posted: 2022-07-27
• Last Update Posted: 2022-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group BPB	Brachial plexus block	The investigators performed a brachial plexus block on that patient group for preoperative anxiety
Group GA	General anesthesia	The investigators performed general anesthesia on that patient group for preoperative anxiety

Primary Outcome Measures

Name	Time	Method
Preoperative anxiety levels in patients who will undergo orthopedic upper extremity surgery with regional or general anesthesia	Preoperative period at day of surgery	This will be assessed by the Amsterdam Preoperative Anxiety and Knowledge Scale (APAIS) in the preoperative period.; The APAIS assessment consists of 6 statements. The measure of agreement with these statements should be graded on a 5-point Likert scale from 1 "not at all" to 5 "extremely." The minimum score is 6, the maximum score is 30. A score of ≥11 identifies anxious patients in clinical practice.

Secondary Outcome Measures

Name	Time	Method
Numerical rating scale (NRS) scores of patients	24 hours postoperatively	Numerical rating scale (NRS) at 1, 8, 16, 24th hours. NRS assessment score ranges from 0-10. 0 = no pain 10 = worst pain imaginable

Trial Locations

Locations (1)

Bakirkoy Dr. Sadi Konuk Research and Training Hospital; 🇹🇷 Istanbul, Bakirkoy, Turkey