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

NCT06638112 | Recruiting DMC

• 1 other identifier: 2408-076-1562
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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. 1.general anesthesia with preoperative brachial plexus block for intra- and postoperative analgesia
2. 2.regional anesthesia (brachial plexus block) with intraoperative sedation.

Conditions

Shoulder Arthroscopy

Outcome Measures

Primary Outcomes (1)

• Quality of recovery (QoR-15) at 48 hours post-surgery

  Quality of recovery (QoR-15) at 48 hours post-surgery (0-150)

  at 48 hours post-surgery

Secondary Outcomes (16)

• Antiemetic administration

  rom end of surgery up to 48 hours post-surgery

• Baseline hemidiagphramatic paralysis

  On the day of surgery, before the operation

• Postoperative hemidiagphramatic paralysis

  Immediately after surgery

• Quality of recovery (QoR-15) on the day before surgery

  on the day before surgery

• Quality of recovery (QoR-15) 24 hours post-surgery

  at 24 hours post-surgery

Study Arms (2)

General anesthesia

ACTIVE COMPARATOR

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

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.

Procedure: Brachial Plexus Block

Interventions

Brachial Plexus Block PROCEDURE

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

Brachial plexus block

General Anesthesia (control group) 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.

General anesthesia

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

RECRUITING

MeSH Terms

Interventions

Brachial Plexus Block; Anesthesia, General; Control Groups

Intervention Hierarchy (Ancestors)

Nerve Block; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Hansol Kim, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hansol Kim, MD

CONTACT

+82220722467; hansolfrkr@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel group, open-label randomized trial

Study Record Dates

• First Submitted: September 29, 2024
• First Posted: October 15, 2024
• Study Start: October 30, 2024
• Primary Completion (Estimated): October 10, 2026
• Study Completion (Estimated): December 10, 2026
• Last Updated: May 15, 2025

Record last verified: 2024-09

Locations

KR (1)