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NCT Number: NCT06674954

Comparison of Perioperative Characteristics of Regional Anasthesia and General Anesthesia

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

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Key information

Conditions

Shoulder Arthroscopy Peripheral Nerve Block

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Etlik City Hospital

Altındağ, Ankara, 06000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Pain Scores

    Time frame: At the 0st, 1st, 2nd,4th, 12th, and 24th hours after the surgery.

    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).

Secondary outcomes

  1. Patient satisfaction

    Time frame: Up to 24 hours after surgery

    Likert scale will be used to evaluate patient satisfaction (5:very satisfied, 4:satisfied, 3:undecided, 2:not satisfied, 1:very dissatisfied)

  2. Surgeon satisfaction

    Time frame: Up to 24 hours after surgery

    Likert scale will be used to evaluate surgeon satisfaction (5:very satisfied, 4:satisfied, 3:undecided, 2:not satisfied, 1:very dissatisfied)

  3. Duration of the surgery

    Time frame: During 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.

  4. Intraoperatif opioid consumption

    Time frame: During surgery

    The amount of remifentanil used during surgery will be recorded. Remifentanil titration will be done according to basal heart rate and blood pressure.

  5. Cost Analysis

    Time frame: Up to 24 hours after surgery

    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.

Sponsors and collaborators

Lead sponsor

Ankara Etlik City Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 5, 2024
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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