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

July 26, 2022 updated by: Gokhan Sertcakacilar, MD, Bakirkoy Dr. Sadi Konuk Research and Training Hospital

A Randomized, Controlled Trial Comparing Preoperative Anxiety Effects of Brachial Plexus Block and General Anesthesia for 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Bakirkoy
      • Istanbul, Bakirkoy, Turkey, 34147
        • Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group BPB
The investigators performed a brachial plexus block on that patient group for preoperative anxiety
Procedure: Brachial plexus block
The effect of brachial plexus block method on preoperative anxiety levels in patients who will undergo orthopedic upper extremity surgery.
Active Comparator: Group GA
The investigators performed general anesthesia on that patient group for preoperative anxiety
Procedure: General anesthesia
The effect of general anesthesia method on preoperative anxiety levels in patients who will undergo orthopedic upper extremity surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Preoperative period at day of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2020

Primary Completion (Actual)

April 15, 2021

Study Completion (Actual)

August 9, 2021

Study Registration Dates

First Submitted

July 25, 2022

First Submitted That Met QC Criteria

July 26, 2022

First Posted (Actual)

July 27, 2022

Study Record Updates

Last Update Posted (Actual)

July 27, 2022

Last Update Submitted That Met QC Criteria

July 26, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-36

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Data available from the publication date can start. Anxiety and NRS scores will be shared. If requested, data will be shared with anesthesiologists dealing with preoperative anxiety.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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