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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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06638112
Enrollment
144
Registered
2024-10-15
Start date
2024-10-30
Completion date
2026-05-31
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Arthroscopy

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

Interventions

PROCEDUREBrachial Plexus Block

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

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.

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Parallel group, open-label randomized trial

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quality of recovery (QoR-15) at 48 hours post-surgeryat 48 hours post-surgeryQuality of recovery (QoR-15) at 48 hours post-surgery (0-150)

Secondary

MeasureTime frameDescription
Antiemetic administrationrom end of surgery up to 48 hours post-surgeryAntiemetic administration from end of surgery up to 48 hours post-surgery
Baseline hemidiagphramatic paralysisOn the day of surgery, before the operationBaseline hemidiagphramatic paralysis
Postoperative hemidiagphramatic paralysisImmediately after surgeryPostoperative hemidiagphramatic paralysis
Quality of recovery (QoR-15) on the day before surgeryon the day before surgeryQuality of recovery (QoR-15) on the day before surgery (0-150)
Quality of recovery (QoR-15) 24 hours post-surgeryat 24 hours post-surgeryQuality of recovery (QoR-15) 24 hours post-surgery (0-150)
Postoperative pain 1 hour post-surgeryat 1 hour post-surgeryPostoperative pain 1 hour post-surgery (Numeric rating scale, 0: no pain; 10: worst pain imaginable)
Postoperative pain 6 hours post-surgeryat 6 hours post-surgeryPostoperative pain 6 hours post-surgery (Numeric rating scale, 0: no pain; 10: worst pain imaginable)
Postoperative pain 12 hours post-surgeryat 12 hours post-surgeryPostoperative pain 12 hours post-surgery (Numeric rating scale, 0: no pain; 10: worst pain imaginable)
Postoperative pain 24 hours post-surgeryat 24 hours post-surgeryPostoperative pain 24 hours post-surgery (Numeric rating scale, 0: no pain; 10: worst pain imaginable)
Postoperative pain 48 hours post-surgeryat 48 hours post-surgeryPostoperative pain 48 hours post-surgery (Numeric rating scale, 0: no pain; 10: worst pain imaginable)
Incidence of postoperative nausea and/or vomiting (PONV) 1 hour post-surgeryat 1 hour post-surgeryIncidence of postoperative nausea and/or vomiting (PONV) 1 hour post-surgery
Incidence of postoperative nausea and/or vomiting (PONV) 6 hours post-surgeryat 6 hours post-surgeryIncidence of postoperative nausea and/or vomiting (PONV) 6 hours post-surgery
Incidence of postoperative nausea and/or vomiting (PONV) 12 hours post-surgeryat 12 hours post-surgeryIncidence of postoperative nausea and/or vomiting (PONV) 12 hours post-surgery
Incidence of postoperative nausea and/or vomiting (PONV) 24 hours post-surgeryat 24 hours post-surgeryIncidence of postoperative nausea and/or vomiting (PONV) 24 hours post-surgery
Incidence of postoperative nausea and/or vomiting (PONV) 48 hours post-surgeryat 48 hours post-surgeryIncidence of postoperative nausea and/or vomiting (PONV) 48 hours post-surgery
Rescue opioid analgesic administrationfrom end of surgery up to 48 hours post-surgeryRescue opioid analgesic administration from end of surgery up to 48 hours post-surgery (morphine milligram equivalent, MME)

Countries

South Korea

Contacts

PRINCIPAL_INVESTIGATORHansol Kim, MD

Seoul National University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 30, 2026