Comparison of Interscalene Block and Suprascapular With Axillary Block

January 31, 2022 updated by: Nur Canbolat, Istanbul University

Comparison of Analgesic Effectiveness of Ultrasound Guided Interscalene Block Versus Suprascapular With Axillary Block in Shoulder Arthroplasties

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Fatih
      • Istanbul, Fatih, Turkey, 34093
        • Istanbul University, Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Study group: interscalene block + IV PCA
preop usg guided interscalene block and IV PCA
Procedure: interscalene block
peripheral nerve block
EXPERIMENTAL: Study group: suprascapular block + axillary block + IV PCA
preop usg guided suprascapular block + axillary block and IV PCA
Procedure: suprascapular block + axillary block
peripheral nerve block
NO_INTERVENTION: Control group: IV PCA
no block + IV PCA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid (mg) consumption
Time Frame: 48 hours
Opioid (mg) consumption
48 hours
Measurement of postoperative pain
Time Frame: 48 hours
VAS (visual analog scale) (0: no pain, 10: the worst pain imaginable)
48 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operation time
Time Frame: during surgery
minutes
during surgery
Hospital stay
Time Frame: postoperative period up to 3 days
days
postoperative period up to 3 days
Postoperatif complication
Time Frame: postoperative period up to 3 days
yes-no
postoperative period up to 3 days
Patient satisfaction
Time Frame: postoperative period up to 3 days
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
Beck Depression Inventory (BDI)
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Investigators

  • Principal Investigator: Kübra Ozkan, MD, Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 30, 2021

Primary Completion (ACTUAL)

January 21, 2022

Study Completion (ACTUAL)

January 31, 2022

Study Registration Dates

First Submitted

January 19, 2021

First Submitted That Met QC Criteria

March 29, 2021

First Posted (ACTUAL)

March 30, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 1, 2022

Last Update Submitted That Met QC Criteria

January 31, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2020/1562

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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