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NCT04769570 Clinical Trial

Effect of Interscalene and Suprascapular Nerve Block on Analgesia Consumption After Adhesive Capsulitis Surgery

Shoulder Surgery Clinical Trial

Official title:
Effect of Interscalene and Suprascapular Nerve Block on Analgesia Consumption After Adhesive Capsulitis Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04769570
Other study ID # 2015/580
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 22, 2021
Est. completion date December 31, 2021

Study information
Verified date July 2022
Source TC Erciyes University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study, a combination of different types of blocks for adhesive capsulitis surgery, the investigators will investigate the impact on patient satisfaction and analgesic consumption after surgery.

Description:

General anesthesia will be performed in all patients for arthroscopic adhesive capsulitis shoulder surgeries. In the first group of patients (Group IPSB), interscalene brachial plexus block will be applied 30 minutes before surgery, while interscalene brachial plexus block and suprascapular nerve block (SSNB) administration to the second group patients (Group SSNB) before surgery. Patients in the third group (Group C) will be considered the control group and no block will be performed. Patient-controlled analgesia (PCA) with morphine will be used in all three groups for postoperative analgesia. Preoperative hemodynamic data of patients, postoperative pain scores (VAS), morphine consumption, patient satisfaction score, requirement of additional analgesia and observed side effects were recorded. Consumption of analgesia 24 hours after surgery and patient satisfaction will be evaluated.

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date December 31, 2021
Est. primary completion date December 29, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - ASA I- ASA II Patients Exclusion Criteria: - history of allergy to the study medication - refusal to participate

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• interscalene brachial plexus block
Single shot ultrasound guided interscalene brachial plexus block will be performed preoperatively to patients.Patient-controlled analgesia (PCA) with morphine will be used for postoperative analgesia.
• suprascapular nerve block
Single shot ultrasound guided interscalene brachial plexus block and Suprascapular nerve block will be performed preoperatively to patients.Patient-controlled analgesia (PCA) with morphine will be used for postoperative analgesia.
• Group Control
consist of the patient group without any procedure.

Locations
Country Name City State
Turkey Sibel Seçkin Pehlivan Kayseri Talas

Sponsors (1)
Lead Sponsor Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Bowens C Jr, Sripada R. Regional blockade of the shoulder: approaches and outcomes. Anesthesiol Res Pract. 2012;2012:971963. doi: 10.1155/2012/971963. Epub 2012 Jun 25. — View Citation

Cabaton J, Nové-Josserand L, Mercadal L, Vaudelin T. Analgesic efficacy of ultrasound-guided interscalene block vs. supraclavicular block for ambulatory arthroscopic rotator cuff repair: A randomised noninferiority study. Eur J Anaesthesiol. 2019 Oct;36(1 — View Citation

Chen HP, Shen SJ, Tsai HI, Kao SC, Yu HP. Effects of Interscalene Nerve Block for Postoperative Pain Management in Patients after Shoulder Surgery. Biomed Res Int. 2015;2015:902745. doi: 10.1155/2015/902745. Epub 2015 Nov 24. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Verbal Analogue Scores A research assistant, blinded to the group allocation, interviewed patients and collected data in the 24 hours postoperative period.Verbal Analog Pain Score value will be the lowest 0 and the highest 10. At the highest value, the patient's pain is at its maximum. and whether higher scores mean worse outcome. 24 hours after surgery
Primary opioid consumption In the recovery room all patients will be given a patient-controlled analgesia device containing morphine and 24 hours postoperative period will be recorded. 24 hours after surgery
Secondary Complications of the procedures The complications of the intervations will be recorded During the blocks and 24 hours after surgery
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Completed NCT01025102 - The Addition of Sufentanil Interscalene Block in Shoulder Surgery Phase 3
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Recruiting NCT03664284 - Does the Disinfection of the Subcutaneous Tissue Reduce the Contamination of the Operative Field by P. Acnes During Primary Shoulder Surgery? N/A
Enrolling by invitation NCT04673344 - Regeneten Patch vs Standard Care in Partial Thickness Rotator Cuff Repair N/A