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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04822610
Other study ID # 2020/1562
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 30, 2021
Est. completion date January 31, 2022

Study information

Verified date January 2022
Source Istanbul University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study, the investigators are going to compare the analgesia effectiveness of interscalane block and suprascapular with axillary block in shoulder arthroplasties


Description:

In the preoperative period, the participants will be taken to the block room. The participants will be monitored, standard sedation will be applied. The first group will be get interscalene block. The second group will be get suprascapular and axillary block. The third group patient will be get no block. Afterwards, the participants will be operated under general anesthesia. A patient-controlled analgesia device will be attached to each group of participants and their postoperative follow-up will be made.


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date January 31, 2022
Est. primary completion date January 21, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - accepting the study protocol, - age older than 18 years and younger than 90 years, - undergoing shoulder arthroplasty surgery - the American Society of Anesthesiologist (ASA) physical status of I-II-III-IV Exclusion Criteria: - severe respiratory distress - patients with local anesthetic allergy - contralateral hemidiaphragmatic parrhesia - recurrent laryngeal nerve palsy - infection at the injection site - coagulation disorder

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
interscalene block
peripheral nerve block
suprascapular block + axillary block
peripheral nerve block

Locations

Country Name City State
Turkey Istanbul University, Faculty of Medicine Istanbul Fatih

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Cho N, Kang RS, McCartney CJL, Pawa A, Costache I, Rose P, Abdallah FW. Analgesic benefits and clinical role of the posterior suprascapular nerve block in shoulder surgery: a systematic review, meta-analysis and trial sequential analysis. Anaesthesia. 2020 Mar;75(3):386-394. doi: 10.1111/anae.14858. Epub 2019 Oct 3. — View Citation

Lee SM, Park SE, Nam YS, Han SH, Lee KJ, Kwon MJ, Ji JH, Choi SK, Park JS. Analgesic effectiveness of nerve block in shoulder arthroscopy: comparison between interscalene, suprascapular and axillary nerve blocks. Knee Surg Sports Traumatol Arthrosc. 2012 Dec;20(12):2573-8. doi: 10.1007/s00167-012-1950-5. Epub 2012 Mar 21. — View Citation

Park JY, Bang JY, Oh KS. Blind suprascapular and axillary nerve block for post-operative pain in arthroscopic rotator cuff surgery. Knee Surg Sports Traumatol Arthrosc. 2016 Dec;24(12):3877-3883. Epub 2016 Jan 5. — View Citation

Toma O, Persoons B, Pogatzki-Zahn E, Van de Velde M, Joshi GP; PROSPECT Working Group collaborators. PROSPECT guideline for rotator cuff repair surgery: systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2019 Oct;74(10):1320-1331. doi: 10.1111/anae.14796. Epub 2019 Aug 7. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Operation time minutes during surgery
Other Hospital stay days postoperative period up to 3 days
Other Postoperatif complication yes-no postoperative period up to 3 days
Other Patient satisfaction 5-point Likert scale: very satisfied (= 5), relatively satisfied (= 4), fairly satisfied (= 3), relatively dissatisfied (= 2) and very dissatisfied (= 1) postoperative period up to 3 days
Other Beck Depression Inventory (BDI) 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression. Will be done 3 times 1- on pre-operative hospitalization 2- in the hospital after surgery 3- in the 1st month follow-up after surgery
Primary Opioid (mg) consumption Opioid (mg) consumption 48 hours
Primary Measurement of postoperative pain VAS (visual analog scale) (0: no pain, 10: the worst pain imaginable) 48 hours
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