Comparison of Different Local Anesthetic Dose in Suprascapular and Axillary Blocks in Shoulder Arthroscopies
Comparison of the Efficacy of Different Local Anesthetic Dosage in Suprascapular and Axillary Blocks in Shoulder Arthroscopy Surgeries
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Fatih
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Istanbul, Fatih, Kalkoen, 34093
- Istanbul University
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: Group 1
In this group, US guided suprascapulary and axillary nerve block will be performed with 15cc+15c local anesthetic.
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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.
Andere namen:
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Actieve vergelijker: Group 2
In this group, US guided suprascapulary and axillary nerve block will be performed with 10cc+10c local anesthetic.
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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.
Andere namen:
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Actieve vergelijker: Group 3
In this group, US guided suprascapulary and axillary nerve block will be performed with 5cc+5c local anesthetic.
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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.
Andere namen:
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Actieve vergelijker: Group 4
In this group, US guided suprascapulary and axillary nerve block will be performed with serum physiologic.
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In this group, US guided suprascapulary and axillary block will be performed with isotonic solution
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Visual Analogue Scale (0-10) pain scores for patients
Tijdsspanne: 48 hours
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The VAS (Visual Analog Scale, 0 ''no pain'', to 10, ''the worst pain possible'')
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48 hours
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Opioid (mg) consumption
Tijdsspanne: postoperative period up to 48th hours.
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Opioid (mg) consumption
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postoperative period up to 48th hours.
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Tijd tot postoperatieve eerste mobilisatie
Tijdsspanne: Tot 48 uur
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Eerste mobilisatietijd
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Tot 48 uur
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Duur van het ziekenhuisverblijf
Tijdsspanne: Door afronding studie gemiddeld 1 week
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Ziekenhuisopname
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Door afronding studie gemiddeld 1 week
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Tevredenheid van de patiënt
Tijdsspanne: postoperatieve periode tot 48 uur en postoperatief in de eerste maand
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Tevredenheidsscore; 0- zeer ontevreden, 3- zeer tevreden
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postoperatieve periode tot 48 uur en postoperatief in de eerste maand
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Tevredenheid van de chirurg
Tijdsspanne: postoperatieve periode tot 48 uur en postoperatief in de eerste maand
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Tevredenheidsscore; 0- zeer ontevreden, 3- zeer tevreden
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postoperatieve periode tot 48 uur en postoperatief in de eerste maand
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Time of onset of narcotic analgesic need
Tijdsspanne: postoperative period up to 48th hours.
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(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.
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postoperative period up to 48th hours.
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Incidence of side effects
Tijdsspanne: postoperative period up to 48th hour
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Incidence of nausea and vomiting
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postoperative period up to 48th hour
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Nil R Kirsan, MD, Istanbul University
Publicaties en nuttige links
Algemene publicaties
- Lee JJ, Kim DY, Hwang JT, Song DK, Lee HN, Jang JS, Lee SS, Hwang SM, Moon SH, Shim JH. Dexmedetomidine combined with suprascapular nerve block and axillary nerve block has a synergistic effect on relieving postoperative pain after arthroscopic rotator cuff repair. Knee Surg Sports Traumatol Arthrosc. 2021 Dec;29(12):4022-4031. doi: 10.1007/s00167-020-06288-8. Epub 2020 Sep 25.
- Ozkan D, Cemaloglu S, Catma FM, Akkaya T. Effects of suprascapular and axillary nerve block on postoperative pain relief sevoflurane consumption and visual clarity in arthroscopic shoulder surgery. Agri. 2020 Jan;32(1):1-7. doi: 10.14744/agri.2019.04875.
- Price D. Optimizing the Combined Suprascapular and Axillary Nerve (SSAX) Block. Reg Anesth Pain Med. 2017 Jan/Feb;42(1):122. doi: 10.1097/AAP.0000000000000518. No abstract available.
- Marty P, Rontes O, Delbos A. A Comparison of Combined Suprascapular and Axillary Nerve Blocks to Interscalene Block: Interpret With Caution. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):273-274. doi: 10.1097/AAP.0000000000000551. No abstract available.
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2020/1830
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