Sammenligning av postoperativ restitusjonskvalitet ved anestesimetode hos pasienter som gjennomgår skulderartroskopi
Sammenligning av postoperativ utvinningskvalitet ved anestesimetode hos pasienter som gjennomgår skulderartroskopi: Brachial Plexus Block for smertekontroll under generell anestesi versus Brachial Plexus Block for kirurgisk blokkering under sedasjon
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:
- general anesthesia with preoperative brachial plexus block for intra- and postoperative analgesia
- regional anesthesia (brachial plexus block) with intraoperative sedation.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Jongno-gu
-
Seoul, Jongno-gu, Sør -Korea, 03080
- Seoul National University Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: General anesthesia
The patient undergoes shoulder arthroscopy under general anesthesia after receiving a preoperative brachial plexus block for intra- and postoperative analgesia. |
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. |
|
Eksperimentell: Brachial plexus block
The patient undergoes shoulder arthroscopy under brachial plexus block and intraoperative sedation with remimazolam or propofol. |
Interscalene brachial plexus block with 0.75% ropivacaine. Intraoperative sedation with remimazolam or propofol. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Quality of recovery (QoR-15) at 48 hours post-surgery
Tidsramme: at 48 hours post-surgery
|
Quality of recovery (QoR-15) at 48 hours post-surgery (0-150) |
at 48 hours post-surgery
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Antiemetic administration
Tidsramme: rom end of surgery up to 48 hours post-surgery
|
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
Tidsramme: On the day of surgery, before the operation
|
Baseline hemidiagphramatic paralysis |
On the day of surgery, before the operation
|
|
Postoperative hemidiagphramatic paralysis
Tidsramme: Immediately after surgery
|
Postoperative hemidiagphramatic paralysis |
Immediately after surgery
|
|
Quality of recovery (QoR-15) on the day before surgery
Tidsramme: 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
Tidsramme: at 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
Tidsramme: at 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
Tidsramme: at 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
Tidsramme: at 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
Tidsramme: at 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
Tidsramme: at 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
Tidsramme: at 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
Tidsramme: at 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
Tidsramme: at 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
Tidsramme: at 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
Tidsramme: at 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
Tidsramme: 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) |
from end of surgery up to 48 hours post-surgery
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Hansol Kim, MD, Seoul National University Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2408-076-1562
Plan for individuelle deltakerdata (IPD)
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