Comparison of Perioperative Characteristics of Regional Anasthesia and General Anesthesia

NCT06674954 | Recruiting

• 1 other identifier: AEŞH-EK1-2024-0125
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Shoulder Arthroscopy; Peripheral Nerve Block

Keywords

Shoulder Arthroscopy; General Anesthesia; Regional Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Patient satisfaction

  Up to 24 hours after surgery

• Surgeon satisfaction

  Up to 24 hours after surgery

• Duration of the surgery

  During surgery

• Intraoperatif opioid consumption

  During surgery

Study Arms (2)

Regional anesthesia

ACTIVE COMPARATOR

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

General anesthesia

ACTIVE COMPARATOR

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

Interventions

Regional Anesthesia PROCEDURE

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.

Regional anesthesia

General Anesthesia PROCEDURE

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.

General anesthesia

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Altındağ, Ankara, 06000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Anesthesia, Conduction; Anesthesia, General

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Central Study Contacts

Atakan Sezgi

CONTACT

00905323327000; kansezgi@gmail.com

Musa Zengin

CONTACT

00905307716235; musazengin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal İnvestigator

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: November 5, 2024
• Study Start: November 14, 2024
• Primary Completion: July 11, 2025
• Study Completion: August 25, 2025
• Last Updated: January 15, 2025

Record last verified: 2025-01

Locations

TU (1)