Shoulder ArthroscopyNCT06674954
Comparison of Perioperative Characteristics of Regional Anasthesia and General Anesthesia
A study testing Regional Anesthesia and General Anesthesia in people with Shoulder Arthroscopy and Peripheral Nerve Block, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Shoulder Arthroscopy, Peripheral Nerve Block
- What is being tested?
- Regional Anesthesia and General Anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Nov 2024to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-80 years
- American Society of Anesthesiologists (ASA) score I-II-III
- Body Mass Index (BMI) between 18-30 kg/m2
Who cannot join
- Patients under 18 and over 80 years of age
- ASA score IV and above
- BMI below 18 or above 30 kg/m2
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Altındağ, Ankara, 06000
About this study
Official title: 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
- Conditions
- Shoulder Arthroscopy, Peripheral Nerve Block
- Being tested
- Regional Anesthesia, General Anesthesia
- Keywords
- Shoulder Arthroscopy, General Anesthesia, Regional Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional AnesthesiaProcedure or surgery
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 AnesthesiaProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: General Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At the 0st, 1st, 2nd,4th, 12th, and 24th hours after the surgery.
Secondary outcomes (5)
Patient satisfaction
Likert scale will be used to evaluate patient satisfaction (5:very satisfied, 4:satisfied, 3:undecided, 2:not satisfied, 1:very dissatisfied)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start14 Nov 2024
- Primary completion10 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shoulder ArthroscopyStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Atakan Sezgi, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06674954
- Sponsor's protocol ID
- AEŞH-EK1-2024-0125
- Status last verified
- May 2026
- First submitted
- 16 Oct 2024
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sezgi A, Zengin M, Catma MF, Kucuk O, Topcu I, Turan MT, Ozguner Y, Aytug EG, Gultop F, Ergil J. Combined regional anesthesia versus general anesthesia for elective shoulder arthroscopy: a prospective randomized trial of postoperative pain, with an exploratory cost analysis. BMC Surg. 2026 Aug 4;26(1):732. doi: 10.1186/s12893-026-04109-2.
PubMed 42958194
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Perioperative Characteristics of Regional Anasthesia and General Anesthesia in Shoulder Arthroscopy
- ClinicalTrials.gov ID
- NCT06674954
- Acronym / sponsor ID
- AEŞH-EK1-2024-0125
- Conditions
- Shoulder Arthroscopy, Peripheral Nerve Block
- Keywords
- Shoulder Arthroscopy, General Anesthesia, Regional Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 14 Nov 2024 (actual)
- Primary completion
- 10 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 5 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regional anesthesia | Active comparator | Procedure: Regional AnesthesiaAfter 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. |
| General anesthesia | Active comparator | Procedure: General AnesthesiaAnesthesia 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18-80 years
- American Society of Anesthesiologists (ASA) score I-II-III
- Body Mass Index (BMI) between 18-30 kg/m2
Key exclusion criteria (3 listed)
- Patients under 18 and over 80 years of age
- ASA score IV and above
- BMI below 18 or above 30 kg/m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regional AnesthesiaAfter 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. | Procedure or surgery | Regional anesthesia |
| General AnesthesiaAnesthesia 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. | Procedure or surgery | General anesthesia |
Primary outcome
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).
5 secondary outcomes
Patient satisfaction
Time frame: Up to 24 hours after surgery
Surgeon satisfaction
Time frame: Up to 24 hours after surgery
Duration of the surgery
Time frame: During surgery
Intraoperatif opioid consumption
Time frame: During surgery
Cost Analysis
Time frame: Up to 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Derived from this study: PubMed 42958194Sezgi A, Zengin M, Catma MF, Kucuk O, Topcu I, Turan MT, Ozguner Y, Aytug EG, Gultop F, Ergil J. Combined regional anesthesia versus general anesthesia for elective shoulder arthroscopy: a prospective randomized trial of postoperative pain, with an exploratory cost analysis. BMC Surg. 2026 Aug 4;26(1):732. doi: 10.1186/s12893-026-04109-2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regional Anesthesia and General Anesthesia in people with Shoulder Arthroscopy and Peripheral Nerve Block, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Scores (time frame: At the 0st, 1st, 2nd,4th, 12th, and 24th hours after the surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06674954, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.