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Comparison of Perioperative Characteristics of Regional Anasthesia and General Anesthesia

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06674954
Enrollment
50
Registered
2024-11-05
Start date
2024-11-14
Completion date
2026-04-30
Last updated
2026-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Nerve Block, Shoulder Arthroscopy

Keywords

Shoulder Arthroscopy, General Anesthesia, Regional Anesthesia

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

Interventions

PROCEDURERegional 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.

PROCEDUREGeneral 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.

Sponsors

Ankara Etlik City Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Pain ScoresAt 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

MeasureTime frameDescription
Patient satisfactionUp to 24 hours after surgeryLikert scale will be used to evaluate patient satisfaction (5:very satisfied, 4:satisfied, 3:undecided, 2:not satisfied, 1:very dissatisfied)
Surgeon satisfactionUp to 24 hours after surgeryLikert scale will be used to evaluate surgeon satisfaction (5:very satisfied, 4:satisfied, 3:undecided, 2:not satisfied, 1:very dissatisfied)
Duration of the surgeryDuring surgeryFor 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.
Intraoperatif opioid consumptionDuring surgeryThe amount of remifentanil used during surgery will be recorded. Remifentanil titration will be done according to basal heart rate and blood pressure.
Cost AnalysisUp to 24 hours after surgeryCost 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 6, 2026