Clinical trial NCT06638112: Comparison of Postoperative Quality of Recovery by Anesthetic Method in Patients Undergoing Shoulder Arthroscopy
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Shoulder Arthroscopy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 140
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel group, open-label randomized trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Quality of recovery (QoR-15) at 48 hours post-surgery
timeFrame: at 48 hours post-surgery
Secondary outcomes:
measure: Antiemetic administration
timeFrame: rom end of surgery up to 48 hours post-surgery
measure: Baseline hemidiagphramatic paralysis
timeFrame: On the day of surgery, before the operation
measure: Postoperative hemidiagphramatic paralysis
timeFrame: Immediately after surgery
measure: Quality of recovery (QoR-15) on the day before surgery
timeFrame: on the day before surgery
measure: Quality of recovery (QoR-15) 24 hours post-surgery
timeFrame: at 24 hours post-surgery
measure: Postoperative pain 1 hour post-surgery
timeFrame: at 1 hour post-surgery
measure: Postoperative pain 6 hours post-surgery
timeFrame: at 6 hours post-surgery
measure: Postoperative pain 12 hours post-surgery
timeFrame: at 12 hours post-surgery
measure: Postoperative pain 24 hours post-surgery
timeFrame: at 24 hours post-surgery
measure: Postoperative pain 48 hours post-surgery
timeFrame: at 48 hours post-surgery
measure: Incidence of postoperative nausea and/or vomiting (PONV) 1 hour post-surgery
timeFrame: at 1 hour post-surgery
measure: Incidence of postoperative nausea and/or vomiting (PONV) 6 hours post-surgery
timeFrame: at 6 hours post-surgery
measure: Incidence of postoperative nausea and/or vomiting (PONV) 12 hours post-surgery
timeFrame: at 12 hours post-surgery
measure: Incidence of postoperative nausea and/or vomiting (PONV) 24 hours post-surgery
timeFrame: at 24 hours post-surgery
measure: Incidence of postoperative nausea and/or vomiting (PONV) 48 hours post-surgery
timeFrame: at 48 hours post-surgery
measure: Rescue opioid analgesic administration
timeFrame: from end of surgery up to 48 hours post-surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno-gu
Study officials:
affiliation: Seoul National University Hospital
name: Hansol Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: