Comparison of Different Local Anesthetic Dose in Suprascapular and Axillary Blocks in Shoulder Arthroscopies
NCT ID: NCT04947007
Last Updated: 2022-03-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
132 participants
INTERVENTIONAL
2021-07-15
2022-03-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison of Local Anesthetic Dose in PENG Block Performed in Total Hip Replacement Operations
NCT04900116
Peng Block or Suprascapular Nerve Block for Postoperative Analgesia in Shoulder Artroscopy ?
NCT05666076
Onset and Recovery of Ultrasound Guided Out-of-plane Versus In-plane Interscalene Block in Arthroscopic Shoulder Surgery
NCT05381389
Combined Suprascapular and Axillary Nerve Blocks for Arthroscopic Shoulder Surgery
NCT03212443
Comparison of Infraclavicular And Supraclavicular Block
NCT04784104
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1
In this group, US guided suprascapulary and axillary nerve block will be performed with 15cc+15c local anesthetic.
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.
Group 2
In this group, US guided suprascapulary and axillary nerve block will be performed with 10cc+10c local anesthetic.
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.
Group 3
In this group, US guided suprascapulary and axillary nerve block will be performed with 5cc+5c local anesthetic.
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.
Group 4
In this group, US guided suprascapulary and axillary nerve block will be performed with serum physiologic.
Isotonic solution
In this group, US guided suprascapulary and axillary block will be performed with isotonic solution
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
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.
Isotonic solution
In this group, US guided suprascapulary and axillary block will be performed with isotonic solution
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients with American Society of Anesthesiology (ASA) Class 1-3
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Istanbul University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Nur Canbolat
Principal Investigator, M.D.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nil R Kirsan, MD
Role: PRINCIPAL_INVESTIGATOR
Istanbul University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Istanbul University
Istanbul, Fatih, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2020/1830
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.