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

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:

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

Study Overview

• Status: Recruiting
• Conditions: Shoulder Arthroscopy
• Intervention / Treatment: Procedure: General Anesthesia (control group); Procedure: Brachial Plexus Block

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hansol Kim, MD; Phone Number: +82220722467; Email: hansolfrkr@gmail.com

Study Locations

• Korea, Republic of
  • Jongno-gu
    • Seoul, Jongno-gu, Korea, Republic of, 03080
      • Recruiting
      • Seoul National University Hospital
      • Contact: Hansol Kim, MD; Phone Number: +82220722467; Email: hansolfrkr@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: General anesthesia; 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); 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.
Experimental: Brachial plexus block; The patient undergoes shoulder arthroscopy under brachial plexus block and intraoperative sedation with remimazolam or propofol.	Procedure: Brachial Plexus Block; Interscalene brachial plexus block with 0.75% ropivacaine. Intraoperative sedation with remimazolam or propofol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antiemetic administration	Antiemetic administration from end of surgery up to 48 hours post-surgery	rom end of surgery up to 48 hours post-surgery
Baseline hemidiagphramatic paralysis	Baseline hemidiagphramatic paralysis	On the day of surgery, before the operation
Postoperative hemidiagphramatic paralysis	Postoperative hemidiagphramatic paralysis	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)	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)	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)	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)	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)	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)	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)	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	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	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	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	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	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)	from end of surgery up to 48 hours post-surgery

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Hansol KIM, MD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2024
• Primary Completion (Estimated): October 10, 2026
• Study Completion (Estimated): December 10, 2026

Study Registration Dates

• First Submitted: September 29, 2024
• First Submitted That Met QC Criteria: October 9, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): May 15, 2025
• Last Update Submitted That Met QC Criteria: May 12, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 2408-076-1562

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No