The Effects of Regional Anaesthesia Techniques on Hemidiaphragm Paralysis, Postoperative Recovery Quality, Opioid Consumption, and Pain Scores

May 6, 2026 updated by: Antalya Training and Research Hospital

Comparion of the Effects of Ultrasound-guided Interscalene Block, Erector Spinae Plane Block, Costoclavicular Block, and Supraclavicular Block on Hemidiaphragm Paralysis, Postoperative Recovery Quality, Opioid Consumption, and Pain Scores in Patients Undergoing Arthroscopic Shoulder Surgery: a Prospective Observational Trial

This study aims to evaluate the effects of ultrasound-guided interscalene, erector spinae plane, costoclavicular, and supraclavicular blocks on hemidiaphragmatic paralysis, postoperative recovery quality, opioid consumption, and pain scores.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Arthroscopic shoulder surgery is a significant approach to diagnosing and treating rotator cuff tears, impingement syndrome, instability, SLAP and Bankart injuries, and other shoulder disorders. Applications of this technique have become increasingly popular in recent yeras. Howeveri although arthroscopic sholuder surgery is conderered minimally invasive, it has been reported to cause moderate to severe postoperative pain, which can hinder patient recovery and rehabilitation, and potentially even extend the hospital stay. Therefore, providing an effective postoperative analgesia strategy in these patients is critical for patient comfort, mobilization, and overall recovery. Various methods are employed to managepostoperative pain in patients undergoing arthroscopic shoulder surgery, with regional techniques being the most prevalent. These regional techniques provide both intraoperative and postoperative analgesia in shoulder surgeries. The aim of this study is to evaluate the effects of ultrasound-guided four block techniques on hemidiaphragmatic paralysis, postoperative recovery quality, opioid consumption, and pain scores.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
88

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • Muratpaşa
      • Antalya, Muratpaşa, Turkey (Türkiye)
        • Recruiting
        • University of Health Sciences, Antalya Training and Research Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

It is planned to include ASA score I-III, aged 18-65 years, who are planned to undergo elective arthroscopic surgery

Description

Inclusion Criteria:

  • aged 18-65 years
  • American Society of Anaesthesiology (ASA) score I-III
  • body mass index (BMI) <30kg/m2
  • scheduled for elective arthroscopic surgery

Exclusion Criteria:

  • ASA score ≥4
  • BMI ≥30 kg/m2
  • declining to give written informed consent
  • controendications for block application
  • history of mental or neurological disease, severe liver and/or kidney disease
  • history of moderate or severe pulmonary disease
  • abnormal preoperative chest X-ray findings
  • scheduled for emergency surgery

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
İnterscalene group
Before the surgery, ultrasoud-guided interscalene block will be performed
Other: İnterscalene block group
Before the surgery, ultrasoud-guided interscalene block will be performed before the surgery under standart anaesthesia monitoring
Erector spinae plane block group
Before the surgery, ultrasoud-guided erector spinae plane block will be performed
Other: Erector spinae plane block group
Before the surgery, ultrasoud-guided erector spinae plane block will be performed before the surgery under standart anaesthesia monitoring
Costoclavicular block group
Before the surgery, ultrasoud-guided costoclavicular block will be performed
Other: Costoclavicular block group
Before the surgery, ultrasoud-guided costoclavicular block will be performed before the surgery under standart anaesthesia monitoring
Supraclavicular block group
Before the surgery, ultrasoud-guided supraclavicular block will be performed
Other: Supraclavivular block group
Before the surgery, ultrasoud-guided supraclavivular block will be performed before the surgery under standart anaesthesia monitoring

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hemidiaphragmatic paralysis
Time Frame: 30 minutes
Diaghragmatic excursion will be assessed using a real-time M-mode ultrasound during quite breathing, deep breathing, and sniffing maneuvers (deep breathing through the nose)
30 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Recovery quality
Time Frame: 5 minutes
The postoperative recovery of patients will be assessed using the 15-item Quality of Recovery (QOR-15) score. The QOR-15 is an 15-item assessment scale that evaluates patients' pain, physical comfort, physical independence, psychological support and emotional state in early postoperative period.
5 minutes
Postoperative analgesic consumption
Time Frame: 24 hours
All patients will receive a standard patient analgesia (PCA) protocol. The postoperative opioid consumption will only be recorded
24 hours
Postoperative pain intensity
Time Frame: 24 hours
The postoperative pain intensity will be assessed with the Numerical Rating Scale (NRS) score (0=no pain; 10=most severe pain)
24 hours

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Antalya Training and Research Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Arzu Karaveli, University of Health Sciences, Antalya Training and Research Hospital
  • Principal Investigator: Bayram Akdag, University of Health Sciences, Antalya Training and Research Hospital
  • Principal Investigator: Fatih Duygun, University of Health Sciences, Antalya Training and Research Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 21, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 21, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 21, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 28, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 4/21

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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