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

Primary Purpose

Orthopedic Disorder, Anxiety, Upper Extremity Injury

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Brachial plexus block
General anesthesia
Sponsored by
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Orthopedic Disorder focused on measuring Brachial plexus block, General anesthesia, Orthopedic surgery, Preoperative anxiety, Upper exremity surgery

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group BPB

Group GA

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
July 25, 2022
Last Updated
July 26, 2022
Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05476198
Brief Title
Brachial Plexus Block vs. General Anesthesia for Anesthesia Anxiety Before Orthopedic Upper Extremity Surgery
Official Title
A Randomized, Controlled Trial Comparing Preoperative Anxiety Effects of Brachial Plexus Block and General Anesthesia for Orthopedic Upper Extremity Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
February 5, 2020 (Actual)
Primary Completion Date
April 15, 2021 (Actual)
Study Completion Date
August 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthopedic Disorder, Anxiety, Upper Extremity Injury, Surgery
Keywords
Brachial plexus block, General anesthesia, Orthopedic surgery, Preoperative anxiety, Upper exremity surgery

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group BPB
Arm Type
Active Comparator
Arm Description
The investigators performed a brachial plexus block on that patient group for preoperative anxiety
Arm Title
Group GA
Arm Type
Active Comparator
Arm Description
The investigators performed general anesthesia on that patient group for preoperative anxiety
Intervention Type
Procedure
Intervention Name(s)
Brachial plexus block
Intervention Description
The effect of brachial plexus block method on preoperative anxiety levels in patients who will undergo orthopedic upper extremity surgery.
Intervention Type
Procedure
Intervention Name(s)
General anesthesia
Intervention Description
The effect of general anesthesia method on preoperative anxiety levels in patients who will undergo orthopedic upper extremity surgery.
Primary Outcome Measure Information:
Title
Preoperative anxiety levels in patients who will undergo orthopedic upper extremity surgery with regional or general anesthesia
Description
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.
Time Frame
Preoperative period at day of surgery
Secondary Outcome Measure Information:
Title
Numerical rating scale (NRS) scores of patients
Description
Numerical rating scale (NRS) at 1, 8, 16, 24th hours. NRS assessment score ranges from 0-10. 0 = no pain 10 = worst pain imaginable
Time Frame
24 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
City
Istanbul
State/Province
Bakirkoy
ZIP/Postal Code
34147
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
35779126
Citation
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.
Results Reference
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PubMed Identifier
29886798
Citation
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.
Results Reference
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PubMed Identifier
25948900
Citation
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.
Results Reference
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PubMed Identifier
30205837
Citation
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.
Results Reference
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Brachial Plexus Block vs. General Anesthesia for Anesthesia Anxiety Before Orthopedic Upper Extremity Surgery

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