Comparison of Perioperative Characteristics of Regional Anasthesia and General Anesthesia

Comparison of Perioperative Characteristics of Regional Anasthesia and General Anesthesia in Shoulder Arthroscopy

Shoulder arthroscopy is one of the most common surgical procedures performed today.It is important to perform the surgical procedure under regional anesthesia to prevent intraoperative complications due to general anesthesia.After shoulder surgery, providing adequate analgesia is necessary for both the comfort of the patient and the ability to perform the necessary post-operative rehabilitation exercises early and regularly.

Nerve blocks reduces opioid consumption in the postoperative period by providing better pain control and therefore has advantages such as fewer side effects and less risk of pulmonary and cardiac complications.

In this study; it was aimed to compare postoperative pain scores, patient satisfaction and surgeon satisfaction in patients who were operated under general anesthesia or who underwent shoulder arthroscopy while awake under regional anesthesia

Study Overview

• Status: Completed
• Conditions: Peripheral Nerve Block; Shoulder Arthroscopy
• Intervention / Treatment: Procedure: Regional Anesthesia; Procedure: General Anesthesia

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Ankara
    • Altındağ, Ankara, Turkey (Türkiye), 06000
      • Ankara Etlik City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients aged 18-80 years
• American Society of Anesthesiologists (ASA) score I-II-III
• Body Mass Index (BMI) between 18-30 kg/m2

Exclusion Criteria:

• Patients under 18 and over 80 years of age
• ASA score IV and above
• BMI below 18 or above 30 kg/m2

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Regional anesthesia; After the patients are monitored and in the supine position, after appropriate field sterilization, interscalene brachial plexus block, superficial cervical block, and supraclavicular brachial plexus block will be applied to these patients under ultrasound guidance. Total of 40 ml of local anesthetic solution (20 ml %0.5 bupivacaine + 10 ml %2 lidocaine + 10 ml physiological saline) will be prepared; 15 ml will be used for interscalene brachial plexus block, 10 ml will be used for superficial cervical block, and 15 ml will be used for supraclavicular brachial plexus block.	Procedure: Regional Anesthesia; After the patients are monitored and in the supine position, after appropriate field sterilization, interscalene brachial plexus block, superficial cervical block, and supraclavicular brachial plexus block will be applied to these patients under ultrasound guidance. Total of 40 ml of local anesthetic solution (20 ml %0.5 bupivacaine + 10 ml %2 lidocaine + 10 ml physiological saline) will be prepared; 15 ml will be used for interscalene brachial plexus block, 10 ml will be used for superficial cervical block, and 15 ml will be used for supraclavicular brachial plexus block. Tramadol (100 mg, intravenous) and dexketoprofen (50 mg, intravenous) will be administered intraoperatively as standard to these patients. Additionally, in the postoperative period a paracetamol dose of 1 g every 8 hours and a dexketoprofen dose of 50 mg twice daily were administered iv for multimodal analgesia.
Active Comparator: General anesthesia; Anesthesia induction will be performed with 2.5 mg/kg propofol, 0.6 mg/kg rocuronium, and 1 mcg/kg fentanyl. Maintenance will be achieved with sevoflurane (MAC: 0.9-1.0) and remifentanil (0.05-0.2 mcg/kg/min). Remifentanil titration will be done according to basal heart rate and blood pressure.	Procedure: General Anesthesia; Anesthesia induction will be performed with 2.5 mg/kg propofol, 0.6 mg/kg rocuronium, and 1 mcg/kg fentanyl. Maintenance will be achieved with sevoflurane (MAC: 0.9-1.0) and remifentanil (0.05-0.2 mcg/kg/min). Remifentanil titration will be done according to basal heart rate and blood pressure. Tramadol (100 mg, intravenous) and dexketoprofen (50 mg, intravenous) will be administered intraoperatively as standard to these patients. Additionally, in the postoperative period a paracetamol dose of 1 g every 8 hours and a dexketoprofen dose of 50 mg twice daily were administered iv for multimodal analgesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scores	Pain will be assessed at rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).	At the 0st, 1st, 2nd,4th, 12th, and 24th hours after the surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	Likert scale will be used to evaluate patient satisfaction (5:very satisfied, 4:satisfied, 3:undecided, 2:not satisfied, 1:very dissatisfied)	Up to 24 hours after surgery
Surgeon satisfaction	Likert scale will be used to evaluate surgeon satisfaction (5:very satisfied, 4:satisfied, 3:undecided, 2:not satisfied, 1:very dissatisfied)	Up to 24 hours after surgery
Duration of the surgery	For general anesthesia: The time from induction to extubation. For regional anesthesia: The time from the application of the block to the end of the surgery.	During surgery
Intraoperatif opioid consumption	The amount of remifentanil used during surgery will be recorded. Remifentanil titration will be done according to basal heart rate and blood pressure.	During surgery
Cost Analysis	Cost analysis will be limited to items that genuinely differ between the two anesthesia techniques. Items administered identically to all patients in both groups (intraoperative tramadol and dexketoprofen, postoperative paracetamol and dexketoprofen, basic monitoring equipment, intravenous cannulas, and crystalloid solutions) will be excluded from the calculation, as they will not contribute to intergroup differences.	Up to 24 hours after surgery

Collaborators and Investigators

• Sponsor: Ankara Etlik City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2024
• Primary Completion (Actual): April 10, 2026
• Study Completion (Actual): April 30, 2026

Study Registration Dates

• First Submitted: October 16, 2024
• First Submitted That Met QC Criteria: November 4, 2024
• First Posted (Actual): November 5, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Regional Anesthesia; General Anesthesia; Shoulder Arthroscopy
• Additional Relevant MeSH Terms: Anesthesia and Analgesia; Anesthesia; Anesthesia, Conduction; Anesthesia, General
• Other Study ID Numbers: AEŞH-EK1-2024-0125

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No