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Completed

NCT Number: NCT05476198

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Istanbul, Bakirkoy, 34147, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brachial Plexus Block

Procedure

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

General Anesthesia

Procedure

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

Primary outcomes

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

    Time frame: 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 outcomes

  1. Numerical rating scale (NRS) scores of patients

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Other Gov

Registry information

Official study title

A Randomized, Controlled Trial Comparing Preoperative Anxiety Effects of Brachial Plexus Block and General Anesthesia for Orthopedic Upper Extremity Surgery

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 27, 2022
Registry last updated
Jul 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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