Comparison of Postoperative Quality of Recovery by Anesthetic Method in Patients Undergoing Shoulder Arthroscopy

NCT ID: NCT06638112

Last Updated: 2025-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-30

Study Completion Date

2026-12-10

Brief Summary

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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. regional anesthesia (brachial plexus block) with intraoperative sedation.

Detailed Description

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Conditions

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Shoulder Arthroscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel group, open-label randomized trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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General anesthesia

The patient undergoes shoulder arthroscopy under general anesthesia after receiving a preoperative brachial plexus block for intra- and postoperative analgesia.

Group Type ACTIVE_COMPARATOR

General Anesthesia (control group)

Intervention Type PROCEDURE

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.

Brachial plexus block

The patient undergoes shoulder arthroscopy under brachial plexus block and intraoperative sedation with remimazolam or propofol.

Group Type EXPERIMENTAL

Brachial Plexus Block

Intervention Type PROCEDURE

Interscalene brachial plexus block with 0.75% ropivacaine. Intraoperative sedation with remimazolam or propofol.

Interventions

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Brachial Plexus Block

Interscalene brachial plexus block with 0.75% ropivacaine. Intraoperative sedation with remimazolam or propofol.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients of age 19 years and above, scheduled for shoulder arthroscopic surgery

Exclusion Criteria

* 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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hansol Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, Jongno-gu, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hansol Kim, MD

Role: CONTACT

+82220722467

Facility Contacts

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Hansol Kim, MD

Role: primary

+82220722467

Other Identifiers

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2408-076-1562

Identifier Type: -

Identifier Source: org_study_id

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