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Completed

NCT Number: NCT04822610

Comparison of Interscalene Block and Suprascapular With Axillary Block

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

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Key information

Conditions

Shoulder Arthroplasty Ultrasound Guided

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University, Faculty of Medicine

Istanbul, Fatih, 34093, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

interscalene block

Procedure

peripheral nerve block

suprascapular block + axillary block

Procedure

peripheral nerve block

Primary outcomes

  1. Opioid (mg) consumption

    Time frame: 48 hours

    Opioid (mg) consumption

  2. Measurement of postoperative pain

    Time frame: 48 hours

    VAS (visual analog scale) (0: no pain, 10: the worst pain imaginable)

Other outcomes

  1. Operation time

    Time frame: during surgery

    minutes

  2. Hospital stay

    Time frame: postoperative period up to 3 days

    days

  3. Postoperatif complication

    Time frame: postoperative period up to 3 days

    yes-no

  4. 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)

  5. 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.

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 30, 2021
Registry last updated
Feb 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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