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Completed

NCT Number: NCT06638112

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

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.

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Key information

Conditions

Shoulder Arthroscopy

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brachial Plexus Block

Procedure

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

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Antiemetic administration

    Time frame: rom end of surgery up to 48 hours post-surgery

    Antiemetic administration from end of surgery up to 48 hours post-surgery

  2. Baseline hemidiagphramatic paralysis

    Time frame: On the day of surgery, before the operation

    Baseline hemidiagphramatic paralysis

  3. Postoperative hemidiagphramatic paralysis

    Time frame: Immediately after surgery

    Postoperative hemidiagphramatic paralysis

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

    Time frame: on the day before surgery

    Quality of recovery (QoR-15) on the day before surgery (0-150)

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

    Time frame: at 24 hours post-surgery

    Quality of recovery (QoR-15) 24 hours post-surgery (0-150)

  6. Postoperative pain 1 hour post-surgery

    Time frame: at 1 hour post-surgery

    Postoperative pain 1 hour post-surgery (Numeric rating scale, 0: no pain; 10: worst pain imaginable)

  7. Postoperative pain 6 hours post-surgery

    Time frame: at 6 hours post-surgery

    Postoperative pain 6 hours post-surgery (Numeric rating scale, 0: no pain; 10: worst pain imaginable)

  8. Postoperative pain 12 hours post-surgery

    Time frame: at 12 hours post-surgery

    Postoperative pain 12 hours post-surgery (Numeric rating scale, 0: no pain; 10: worst pain imaginable)

  9. Postoperative pain 24 hours post-surgery

    Time frame: at 24 hours post-surgery

    Postoperative pain 24 hours post-surgery (Numeric rating scale, 0: no pain; 10: worst pain imaginable)

  10. Postoperative pain 48 hours post-surgery

    Time frame: at 48 hours post-surgery

    Postoperative pain 48 hours post-surgery (Numeric rating scale, 0: no pain; 10: worst pain imaginable)

  11. 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) 1 hour post-surgery

  12. 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) 6 hours post-surgery

  13. 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) 12 hours post-surgery

  14. 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) 24 hours post-surgery

  15. Incidence of postoperative nausea and/or vomiting (PONV) 48 hours post-surgery

    Time frame: at 48 hours post-surgery

    Incidence of postoperative nausea and/or vomiting (PONV) 48 hours post-surgery

  16. Rescue opioid analgesic administration

    Time frame: from end of surgery up to 48 hours post-surgery

    Rescue opioid analgesic administration from end of surgery up to 48 hours post-surgery (morphine milligram equivalent, MME)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 15, 2024
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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