Clinical trial NCT05476198: 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
Overall status: COMPLETED
Phase: NA
Conditions: Orthopedic Disorder
Anxiety
Upper Extremity Injury
Surgery
Keywords: Brachial plexus block
General anesthesia
Orthopedic surgery
Preoperative anxiety
Upper exremity surgery
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2022-07-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Preoperative anxiety levels in patients who will undergo orthopedic upper extremity surgery with regional or general anesthesia
timeFrame: Preoperative period at day of surgery
Secondary outcomes:
measure: Numerical rating scale (NRS) scores of patients
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
state: Bakirkoy
Study officials:
References:
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.
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.
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.
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.