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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05666076
Other study ID # 2022-360
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 14, 2022
Est. completion date November 17, 2023

Study information

Verified date November 2022
Source Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Contact Gokhan Sertcakacilar, MD
Phone 00905053130818
Email drgokhansertcakacilar@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Arthroscopic shoulder surgery, which has been frequently applied in recent years, provides long-term positive clinical results and increases the quality of life after surgery, while it can cause severe pain in the early postoperative period. Postoperative pain management is very important in shoulder arthroplasty. Adequate pain control; mental state, nutrition, cost of care, rehabilitation, and patient satisfaction, are of great importance for the patients' recovery and contribute to a successful surgical outcome. In this study, the investigators aimed to compare the effects of suprascapular nerve block and shoulder pericapsular nerve block, which will be performed preoperatively with ultrasound, on the level of postoperative pain in patients who will undergo shoulder arthroscopy surgery under general anesthesia.


Description:

As a result of the power analysis the investigators conducted for this study, the minimum sample size was calculated as 32 people for each group, 64 people in total, at the 90% confidence interval. 64 patients who meet the inclusion criteria will be included in our study. The participants will be randomized and divided into 2 groups. Accordingly, the PENG block will be applied to 32 patients, and the suprascapular block will be applied to 32 patients.


Recruitment information / eligibility

Status Recruiting
Enrollment 74
Est. completion date November 17, 2023
Est. primary completion date September 22, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Patients who will have shoulder arthroscopy surgery under general anesthesia - Ages of 18-75 - ASA I-III Exclusion Criteria: - Patients with deformity and pathology in the shoulder region - Patients with known local anesthetic allergy - Patients with BMI>35 - Patients with alcohol and substance addiction - Patients with opioid addiction - Patients who cannot perceive and evaluate pain, such as psychiatric illness, mental retardation

Study Design


Intervention

Procedure:
Pericapsular nerve block
The investigators will perform a pericapsular nerve block on that patient group for postoperative analgesia in shoulder arthroscopy.
Suprascapular nerve block
The investigators will perform a suprascapular nerve block on that patient group for postoperative analgesia in shoulder arthroscopy.
Drug:
Bupivacaine and prilocaine hydrochloride
The investigators will perform a pericapsular nerve block on that patient group for postoperative analgesia with bupivacaine and prilocaine hydrochloride
Bupivacaine and prilocaine hydrochloride
The investigators will perform a suprascapular nerve block on that patient group for postoperative analgesia with bupivacaine and prilocaine hydrochloride

Locations

Country Name City State
Turkey Bakirkoy Dr. Sadi Konuk Research and Training Hospital Istanbul Bakirkoy

Sponsors (1)

Lead Sponsor Collaborator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Kupeli I, Yazici Kara M. Anesthesia or analgesia? New block for shoulder surgery: pericapsular nerve group block. Braz J Anesthesiol. 2022 Sep-Oct;72(5):669-672. doi: 10.1016/j.bjane.2021.05.009. Epub 2021 Jun 9. — View Citation

Sun C, Zhang X, Ji X, Yu P, Cai X, Yang H. Suprascapular nerve block and axillary nerve block versus interscalene nerve block for arthroscopic shoulder surgery: A meta-analysis of randomized controlled trials. Medicine (Baltimore). 2021 Nov 5;100(44):e27661. doi: 10.1097/MD.0000000000027661. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The primary outcome measure of the study is the patients' postoperative pain scores (NRS) Numerical rating scale (NRS) at 1, 6, 12, 18, 24, 30, and 36th hours. A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable. 36 hours postoperatively
Secondary Postoperative 36-hour total tramadol hydrochloride consumption This will be measured by the PCA device in the 36 hours after 36 hours postoperatively
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