Shoulder ArthroscopyNCT06638112
Comparison of Postoperative Quality of Recovery by Anesthetic Method in Patients Undergoing Shoulder Arthroscopy
A study testing Brachial Plexus Block in people with Shoulder Arthroscopy, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The aim of this study is to compare the quality of recovery in patients undergoing arthroscopic shoulder surgery depending on the type of anesthesia used: 1. general anesthesia with preoperative brachial plexus block for intra- and postoperative analgesia 2. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Shoulder Arthroscopy
- What is being tested?
- Brachial Plexus Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Oct 2024to 31 May 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of age 19 years and above, scheduled for shoulder arthroscopic surgery
Who cannot join
- emergency operation
- inflammation or infection at the site of nerve block administration
- inability to perform the quality of recovery questionnaire due to dementia or delirium
- severe lung disease (e.g. chronic obstructive pulmonary disease or interstitial lung disease)
- contraindication to brachial plexus block
- history of hypersensitivity or side effect to ropivacaine
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Jongno-gu, 03080
About this study
Official title: Comparison of Postoperative Quality of Recovery by Anesthetic Method in Patients Undergoing Shoulder Arthroscopy: Brachial Plexus Block for Pain Control Under General Anesthesia Versus Brachial Plexus Block for Surgical Block Under Sedation
The aim of this study is to compare the quality of recovery in patients undergoing arthroscopic shoulder surgery depending on the type of anesthesia used:
- general anesthesia with preoperative brachial plexus block for intra- and postoperative analgesia
- regional anesthesia (brachial plexus block) with intraoperative sedation.
- Conditions
- Shoulder Arthroscopy
- Being tested
- Brachial Plexus Block, General Anesthesia (control group)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brachial Plexus BlockProcedure or surgery
Interscalene brachial plexus block with 0.75% ropivacaine. Intraoperative sedation with remimazolam or propofol.
General Anesthesia (control group)Procedure or surgery
General anesthesia with propofol, fentanyl and rocuronium for induction, and with sevoflurane for maintenance. Brachial plexus block with 0.5% ropivacaine for intra- and postoperative analgesia.
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia | Active comparator | The patient undergoes shoulder arthroscopy under general anesthesia after receiving a preoperative brachial plexus block for intra- and postoperative analgesia. Receives: Procedure: General Anesthesia (control group) |
| Brachial plexus block | Experimental | The patient undergoes shoulder arthroscopy under brachial plexus block and intraoperative sedation with remimazolam or propofol. Receives: Procedure: Brachial Plexus Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of recovery (QoR-15) at 48 hours post-surgery
Quality of recovery (QoR-15) at 48 hours post-surgery (0-150)
Measured: at 48 hours post-surgery
Secondary outcomes (16)
Antiemetic administration
Antiemetic administration from end of surgery up to 48 hours post-surgery
Measured: rom end of surgery up to 48 hours post-surgery
Baseline hemidiagphramatic paralysis
Baseline hemidiagphramatic paralysis
Measured: On the day of surgery, before the operation
Postoperative hemidiagphramatic paralysis
Postoperative hemidiagphramatic paralysis
Measured: Immediately after surgery
Quality of recovery (QoR-15) on the day before surgery
Quality of recovery (QoR-15) on the day before surgery (0-150)
Measured: on the day before surgery
Quality of recovery (QoR-15) 24 hours post-surgery
Quality of recovery (QoR-15) 24 hours post-surgery (0-150)
Measured: at 24 hours post-surgery
Postoperative pain 1 hour post-surgery
Postoperative pain 1 hour post-surgery (Numeric rating scale, 0: no pain; 10: worst pain imaginable)
Measured: at 1 hour post-surgery
Postoperative pain 6 hours post-surgery
Postoperative pain 6 hours post-surgery (Numeric rating scale, 0: no pain; 10: worst pain imaginable)
Measured: at 6 hours post-surgery
Postoperative pain 12 hours post-surgery
Postoperative pain 12 hours post-surgery (Numeric rating scale, 0: no pain; 10: worst pain imaginable)
Measured: at 12 hours post-surgery
Postoperative pain 24 hours post-surgery
Postoperative pain 24 hours post-surgery (Numeric rating scale, 0: no pain; 10: worst pain imaginable)
Measured: at 24 hours post-surgery
Postoperative pain 48 hours post-surgery
Postoperative pain 48 hours post-surgery (Numeric rating scale, 0: no pain; 10: worst pain imaginable)
Measured: at 48 hours post-surgery
Incidence of postoperative nausea and/or vomiting (PONV) 1 hour post-surgery
Incidence of postoperative nausea and/or vomiting (PONV) 1 hour post-surgery
Measured: at 1 hour post-surgery
Incidence of postoperative nausea and/or vomiting (PONV) 6 hours post-surgery
Incidence of postoperative nausea and/or vomiting (PONV) 6 hours post-surgery
Measured: at 6 hours post-surgery
Incidence of postoperative nausea and/or vomiting (PONV) 12 hours post-surgery
Incidence of postoperative nausea and/or vomiting (PONV) 12 hours post-surgery
Measured: at 12 hours post-surgery
Incidence of postoperative nausea and/or vomiting (PONV) 24 hours post-surgery
Incidence of postoperative nausea and/or vomiting (PONV) 24 hours post-surgery
Measured: at 24 hours post-surgery
Incidence of postoperative nausea and/or vomiting (PONV) 48 hours post-surgery
Incidence of postoperative nausea and/or vomiting (PONV) 48 hours post-surgery
Measured: at 48 hours post-surgery
Rescue opioid analgesic administration
Rescue opioid analgesic administration from end of surgery up to 48 hours post-surgery (morphine milligram equivalent, MME)
Measured: from end of surgery up to 48 hours post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start30 Oct 2024
- Primary completion31 May 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder ArthroscopyStudies of the same condition, open and under way.
- More trials run by Seoul National University 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
- Model description
- Parallel group, open-label randomized trial
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hansol Kim, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06638112
- Sponsor's protocol ID
- 2408-076-1562
- Status last verified
- Sep 2024
- First submitted
- 29 Sep 2024
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Quality of Recovery by Anesthetic Method in Patients Undergoing Shoulder Arthroscopy: Brachial Plexus Block for Pain Control Under General Anesthesia Versus Brachial Plexus Block for Surgical Block Under Sedation
- ClinicalTrials.gov ID
- NCT06638112
- Acronym / sponsor ID
- 2408-076-1562
- Conditions
- Shoulder Arthroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 15 Oct 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.
The aim of this study is to compare the quality of recovery in patients undergoing arthroscopic shoulder surgery depending on the type of anesthesia used:
- general anesthesia with preoperative brachial plexus block for intra- and postoperative analgesia
- regional anesthesia (brachial plexus block) with intraoperative sedation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel group, open-label randomized trial
| Arm | Type | Receives |
|---|---|---|
| General anesthesia | Active comparator | Procedure: General Anesthesia (control group)The patient undergoes shoulder arthroscopy under general anesthesia after receiving a preoperative brachial plexus block for intra- and postoperative analgesia. |
| Brachial plexus block | Experimental | Procedure: Brachial Plexus BlockThe patient undergoes shoulder arthroscopy under brachial plexus block and intraoperative sedation with remimazolam or propofol. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients of age 19 years and above, scheduled for shoulder arthroscopic surgery
Key exclusion criteria (6 listed)
- emergency operation
- inflammation or infection at the site of nerve block administration
- inability to perform the quality of recovery questionnaire due to dementia or delirium
- severe lung disease (e.g. chronic obstructive pulmonary disease or interstitial lung disease)
- contraindication to brachial plexus block
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 |
|---|---|---|
| Brachial Plexus BlockInterscalene brachial plexus block with 0.75% ropivacaine. Intraoperative sedation with remimazolam or propofol. | Procedure or surgery | Brachial plexus block |
| General Anesthesia (control group)General anesthesia with propofol, fentanyl and rocuronium for induction, and with sevoflurane for maintenance. Brachial plexus block with 0.5% ropivacaine for intra- and postoperative analgesia. | Procedure or surgery | General anesthesia |
Primary outcome
Quality of recovery (QoR-15) at 48 hours post-surgery
Time frame: at 48 hours post-surgery
Quality of recovery (QoR-15) at 48 hours post-surgery (0-150)
16 secondary outcomes
Antiemetic administration
Time frame: rom end of surgery up to 48 hours post-surgery
Baseline hemidiagphramatic paralysis
Time frame: On the day of surgery, before the operation
Postoperative hemidiagphramatic paralysis
Time frame: Immediately after surgery
Quality of recovery (QoR-15) on the day before surgery
Time frame: on the day before surgery
Quality of recovery (QoR-15) 24 hours post-surgery
Time frame: at 24 hours post-surgery
Postoperative pain 1 hour post-surgery
Time frame: at 1 hour post-surgery
Postoperative pain 6 hours post-surgery
Time frame: at 6 hours post-surgery
Postoperative pain 12 hours post-surgery
Time frame: at 12 hours post-surgery
Postoperative pain 24 hours post-surgery
Time frame: at 24 hours post-surgery
Postoperative pain 48 hours post-surgery
Time frame: at 48 hours post-surgery
Incidence of postoperative nausea and/or vomiting (PONV) 1 hour post-surgery
Time frame: at 1 hour post-surgery
Incidence of postoperative nausea and/or vomiting (PONV) 6 hours post-surgery
Time frame: at 6 hours post-surgery
Incidence of postoperative nausea and/or vomiting (PONV) 12 hours post-surgery
Time frame: at 12 hours post-surgery
Incidence of postoperative nausea and/or vomiting (PONV) 24 hours post-surgery
Time frame: at 24 hours post-surgery
Incidence of postoperative nausea and/or vomiting (PONV) 48 hours post-surgery
Time frame: at 48 hours post-surgery
Rescue opioid analgesic administration
Time frame: from end of surgery up to 48 hours post-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 4 Nov 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Shoulder Arthroscopy
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Recruiting
Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block for Analgesia in Arthroscopic Shoulder Surgery
Postoperative Pain, Acute, Shoulder Pain
Not yet recruiting
ESP Versus SPSIP Block for Pain Relief After Shoulder Arthroscopy
Postoperative Pain
Active, not recruitingObservational study
Outcomes of Arthroscopic Dynamic Anterior Stabilization With and Without Remplissage
Anterior Shoulder Instability
RecruitingObservational study
SPSIP Block in Shoulder Artroscopy
Shoulder Arthroscopic Surgeries
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.
Hansol Kim, MD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brachial Plexus Block in people with Shoulder Arthroscopy, run by Seoul National University Hospital at 1 site in South Korea.
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 1 inclusion and 6 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 4 Nov 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 South Korea. 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?
Quality of recovery (QoR-15) at 48 hours post-surgery (time frame: at 48 hours post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2026.