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Clinical Trials/NCT06674954
NCT06674954CompletedNot Applicable

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

Ankara Etlik City Hospital2 sites in 2 countries50 target enrollmentStarted: November 14, 2024Last updated:
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
50
Locations
2
Primary Endpoint
Pain Scores

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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.

Intervention: Regional Anesthesia (Procedure)

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.

Intervention: General Anesthesia (Procedure)

Outcomes

Primary Outcomes

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

  • 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)

Investigators

Sponsor
Ankara Etlik City Hospital
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Atakan Sezgi

Principal İnvestigator

Ankara Etlik City Hospital

Study Sites (2)

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