Shoulder Arthroscopy
Conditions
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
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
Study design
Intervention model description
Parallel group, open-label randomized trial
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Quality of recovery (QoR-15) at 48 hours post-surgery | at 48 hours post-surgery | Quality of recovery (QoR-15) at 48 hours post-surgery (0-150) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antiemetic administration | rom end of surgery up to 48 hours post-surgery | Antiemetic administration from end of surgery up to 48 hours post-surgery |
| Baseline hemidiagphramatic paralysis | On the day of surgery, before the operation | Baseline hemidiagphramatic paralysis |
| Postoperative hemidiagphramatic paralysis | Immediately after surgery | Postoperative hemidiagphramatic paralysis |
| Quality of recovery (QoR-15) on the day before surgery | on the day before surgery | Quality of recovery (QoR-15) on the day before surgery (0-150) |
| Quality of recovery (QoR-15) 24 hours post-surgery | at 24 hours post-surgery | Quality of recovery (QoR-15) 24 hours post-surgery (0-150) |
| Postoperative pain 1 hour post-surgery | at 1 hour post-surgery | Postoperative pain 1 hour post-surgery (Numeric rating scale, 0: no pain; 10: worst pain imaginable) |
| Postoperative pain 6 hours post-surgery | at 6 hours post-surgery | Postoperative pain 6 hours post-surgery (Numeric rating scale, 0: no pain; 10: worst pain imaginable) |
| Postoperative pain 12 hours post-surgery | at 12 hours post-surgery | Postoperative pain 12 hours post-surgery (Numeric rating scale, 0: no pain; 10: worst pain imaginable) |
| Postoperative pain 24 hours post-surgery | at 24 hours post-surgery | Postoperative pain 24 hours post-surgery (Numeric rating scale, 0: no pain; 10: worst pain imaginable) |
| Postoperative pain 48 hours post-surgery | at 48 hours post-surgery | Postoperative 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-surgery | at 1 hour post-surgery | Incidence of postoperative nausea and/or vomiting (PONV) 1 hour 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) 6 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) 12 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) 24 hours post-surgery |
| Incidence of postoperative nausea and/or vomiting (PONV) 48 hours post-surgery | at 48 hours post-surgery | Incidence of postoperative nausea and/or vomiting (PONV) 48 hours post-surgery |
| Rescue opioid analgesic administration | 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) |
Countries
South Korea
Contacts
Seoul National University Hospital