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Comparison of Different Local Anesthetic Dose in Suprascapular and Axillary Blocks in Shoulder Arthroscopies

1. marts 2022 opdateret af: Nur Canbolat, Istanbul University

Comparison of the Efficacy of Different Local Anesthetic Dosage in Suprascapular and Axillary Blocks in Shoulder Arthroscopy Surgeries

The research is designed as a single-center, prospective, randomized double-blind study. The patients undergoing shoulder arthroscopy surgery in Istanbul University, Istanbul Faculty of Medicine, Department of Orthopedics and Traumatology will be included. Patients who are legally authorized to make decisions on their behalf will be informed about the research and their written consent will be obtained. Patients who do not give consent will be excluded. Ultrasonography (USG) guided combined suprascapular and axillary block will be performed routinely for postoperative analgesia. After the block is performed, general anesthesia will be applied. The patients will be divided into 4 groups. Three different doses of local anesthetic will be given to patients (30 cc vs 20 cc vs 10 cc). Local anesthetic dose will be the same for suprascapular and axillary blocks. The fourth group will be sham control. Pain score will be determined by visual pain scoring (VAS) and analgesic consumption will be provided by the use of a patient controlled analgesia (PCA) device with intravenous morphine applied in routine practice to all four groups at the postoperative 1, 4, 8,12 and 24 hours. Patient will be observed for postoperative nausea and vomiting, first time to mobilization, length of hospital stay, analgesic consumption and satisfaction of surgeon and patient.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The investigators research was designed as a single-center, prospective, randomized double-blind study.

After the approval of the Ethics Committee, the study will start and is aimed to be completed in 6 months. The patients consecutively undergoing shoulder arthroscopy surgery in Istanbul University Istanbul Faculty of Medicine, Department of Orthopedics and Traumatology will be included. Patients who are legally authorized to make decisions on their behalf will be informed about the research and their written consent will be obtained. Patients who do not give consent will not be included in the study.

Preoperative evaluation of the patients will include detailed history, demographic and clinical parameters including gender, age, indication for shoulder arthroscopy, creatinine, chronic disease history will be recorded. Patients will be taken to the operating room after premedication with 2 mg midazolam and 50 mg fentanyl.

Patients will be monitored for rhythm, blood oxygen and pressure in the operating room. Ultrasonography (USG) guided suprascapular and axillary block will be performed. Suprascapular and axillary block will be done for postoperative analgesia. After the block is done, general anesthesia will be applied. In this study there will be four groups with the control group included. For the first group 15cc+15cc , for the second group 10cc+10cc for the third group 5cc+5cc of local anesthetic will be injected. The fourth group will be sham control.

Pain score will be determined by visual pain scoring (VAS) and analgesic consumption will be provided by the use of a patient controlled analgesia (PCA) device with intravenous morphine applied in routine practice to all four groups at the postoperative 1, 4, 8,12 and 24 hours. Patients will be followed up for 48 hours postoperatively in routine practice. They will be observed for postoperative nausea and vomiting, first mobilisation time, lenght of hospital stay, analgesic consumption and surgent and patient satisfaction.

Before the study, it was determined that at least 132 patients should be collected in the power analysis performed with the help of similar literature data. After collecting the demographic data and morphine consumption data of the patients, statistical analysis will be performed with Statistical Package for the Social Sciences (SPSS). The investigators study does not contain any modifications other than the investigators daily routine practices.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

132

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kalkun
    • Fatih
      • Istanbul, Fatih, Kalkun, 34093
        • Istanbul University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patients scheduled for total shoulder arthroscopy surgery
  • Patients with American Society of Anesthesiology (ASA) Class 1-3

Exclusion Criteria:

  • Refusal of regional anesthesia
  • Infection on the local anesthetic application area
  • Patients with known coagulopathy
  • Known allergy against local anesthetics
  • Anatomical difficulties to perform supra scapular and axillary blocks

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Group 1
In this group, US guided suprascapulary and axillary nerve block will be performed with 15cc+15c local anesthetic.
Medicin: Bupivacaine hydrogen chloride (HCl) 0.025 % in 15+15 ML Injection
In this group, US guided suprascapulary and axillary block will be performed with 15 ml +15 ml 0.025% bupivacaine for each block site using a 22 gauge 10 mm block needle.
Andre navne:
  • Marcaine
Aktiv komparator: Group 2
In this group, US guided suprascapulary and axillary nerve block will be performed with 10cc+10c local anesthetic.
Medicin: Bupivacaine HCl 0.025 % in 10+10 ML Injection
In this group, US guided suprascapulary and axillary block will be performed with 10 ml +10 ml 0.025% bupivacaine for each block site using a 22 gauge 10 mm block needle.
Andre navne:
  • Marcaine
Aktiv komparator: Group 3
In this group, US guided suprascapulary and axillary nerve block will be performed with 5cc+5c local anesthetic.
Medicin: Bupivacaine HCl 0.025 % in 5+5 ML Injection
In this group, US guided suprascapulary and axillary block will be performed with 5 ml +5 ml 0.025% bupivacaine for each block site using a 22 gauge 10 mm block needle.
Andre navne:
  • Marcaine
Aktiv komparator: Group 4
In this group, US guided suprascapulary and axillary nerve block will be performed with serum physiologic.
Medicin: Isotonic solution
In this group, US guided suprascapulary and axillary block will be performed with isotonic solution
Andre navne:
  • serum fysiologisk

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Visual Analogue Scale (0-10) pain scores for patients
Tidsramme: 48 hours
The VAS (Visual Analog Scale, 0 ''no pain'', to 10, ''the worst pain possible'')
48 hours

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Opioid (mg) consumption
Tidsramme: postoperative period up to 48th hours.
Opioid (mg) consumption
postoperative period up to 48th hours.

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Tid til postoperativ første mobilisering
Tidsramme: Op til 48 timer
Første mobiliseringstid
Op til 48 timer
Længde af hospitalsophold
Tidsramme: Gennem studieafslutning i gennemsnit 1 uge
Hospitalsindlæggelse
Gennem studieafslutning i gennemsnit 1 uge
Patienttilfredshed
Tidsramme: postoperativ periode op til 48 timer og postoperativ i den første måned
Tilfredshedsscore; 0- meget utilfreds, 3- meget tilfreds
postoperativ periode op til 48 timer og postoperativ i den første måned
Kirurgens tilfredshed
Tidsramme: postoperativ periode op til 48 timer og postoperativ i den første måned
Tilfredshedsscore; 0- meget utilfreds, 3- meget tilfreds
postoperativ periode op til 48 timer og postoperativ i den første måned
Time of onset of narcotic analgesic need
Tidsramme: postoperative period up to 48th hours.
(If VAS > 4, morphine 0.05 mg/kg IV will be administered as rescue analgesia additional analgesia and maximum will be increased to 10 mg.
postoperative period up to 48th hours.
Incidence of side effects
Tidsramme: postoperative period up to 48th hour
Incidence of nausea and vomiting
postoperative period up to 48th hour

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Istanbul University

Efterforskere

  • Ledende efterforsker: Nil R Kirsan, MD, Istanbul University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. juli 2021

Primær færdiggørelse (Faktiske)

21. februar 2022

Studieafslutning (Faktiske)

1. marts 2022

Datoer for studieregistrering

Først indsendt

24. juni 2021

Først indsendt, der opfyldte QC-kriterier

24. juni 2021

Først opslået (Faktiske)

1. juli 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. marts 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. marts 2022

Sidst verificeret

1. marts 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2020/1830

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