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

NCT05476198 | Completed DMC

• 1 other identifier: 2020-36
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthopedic Disorder; Anxiety; Upper Extremity Injury; Surgery

Keywords

Brachial plexus block; General anesthesia; Orthopedic surgery; Preoperative anxiety; Upper exremity surgery

Outcome Measures

Primary Outcomes (1)

• Preoperative anxiety levels in patients who will undergo orthopedic upper extremity surgery with regional or general anesthesia

  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.

  Preoperative period at day of surgery

Secondary Outcomes (1)

• Numerical rating scale (NRS) scores of patients

  24 hours postoperatively

Study Arms (2)

Group BPB

ACTIVE COMPARATOR

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

Procedure: Brachial plexus block

Group GA

ACTIVE COMPARATOR

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

Procedure: General anesthesia

Interventions

Brachial plexus block PROCEDURE

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

Group BPB

General anesthesia PROCEDURE

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

Group GA

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Istanbul, Bakirkoy, 34147, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 35779126 BACKGROUND

• 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.

  PMID: 29886798 BACKGROUND

• 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.

  PMID: 25948900 BACKGROUND

• 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.

  PMID: 30205837 BACKGROUND

MeSH Terms

Conditions

Musculoskeletal Diseases; Anxiety Disorders; Arm Injuries

Interventions

Brachial Plexus Block; Anesthesia, General

Condition Hierarchy (Ancestors)

Mental Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Nerve Block; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: July 27, 2022
• Study Start: February 5, 2020
• Primary Completion: April 15, 2021
• Study Completion: August 9, 2021
• Last Updated: July 27, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

TU (1)