Ultrasound Guided Suprascapular Nerve Block Versus ISB Block in Arthroscopic Shoulder Surgery

May 1, 2024 updated by: Ramy Mousa, Benha University

A Comparison Between Ultrasound Guided Suprascapular Nerve Block Versus Ultrasound Guided Interscalene Brachial Plexus Block on Respiratory Mechanics in Patients Undergoing Arthroscopic Shoulder Surgery: A Randomized Controlled Study

Diaphragmatic dysfunction can be detected as a decrease in forced vital capacity (FVC) and forced expiratory volume at 1 s (FEV1) on spirometry or as lower diaphragmatic excursion (DE) on US, the latter having become the gold standard in thoracic assessment.

Study Overview

Status

Status

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

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Detailed Description

Severe intraoperative and postoperative pain associated with arthroscopic shoulder surgery has high incidence reaching up to 45%; it is often significant enough to interfere with initial recovery and rehabilitation.

Shoulder arthroscopy is becoming more common, representing the second most common Orthopedic surgery after knee arthroscopy . Interscalene brachial plexus block (ISB) is the gold standard analgesic technique for shoulder surgeries with success rates of 87% to 100%, but it also blocks the phrenic nerve (C3-C5).

Suprascapular nerve block via the anterior approach (SSB-A) is performed distally at the trunk/division level of the brachial plexus, thereby potentially sparing the phrenic nerve and minimising many adverse effects of ISB

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.
Interventional

Enrollment (Actual)

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.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Egypt
      • Banha, Egypt, 13511
        • Benha University

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

Description

Inclusion Criteria:

  • aged (18-65 years)
  • American Society of Anesthesiologists (ASA) physical status I or II
  • scheduled for elective arthroscopic shoulder surgery

Exclusion Criteria:

  • pre-existing respiratory,
  • cardiac, renal, neurological, or hepatic disease, neuropathy affecting brachial plexus
  • contraindication to peripheral nerve block (e.g., coagulopathy),

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Experimental: interscalene block group
patients received an ultrasound guided interscalene approach of brachial plexus plane block
Procedure: interscalene block group
The ISB group scanning was done by linear ultrasound probe just below the level of the cricoid cartilage medial to the sternocleidomastoid muscle; the skin was disinfected, and the transducer was positioned in the transverse plane to identify the carotid artery. Once the artery was identified, the transducer was moved slightly laterally across the neck to identify the scalene muscles and the brachial plexus that is present between the anterior and middle scalene muscles. 3 ml lidocaine 1% was injected at puncture site The needle was then inserted in-plane toward the brachial plexus, in a lateral-to-medial direction. After a careful aspiration, 20 ml of bupivacaine 0.25% was injected.
Other Names:
  • Group ISB
Experimental: suprascapular nerve block group
patients received ultrasound guided suprascapular nerve block.
Procedure: Suprascapular nerve block group
After cleaning the skin with an antiseptic solution, an ultrasound probe was put in sagittal orientation at the superior medial border of the scapula to identify the pleura and then moved laterally; when it was parallel to the spine of the scapula, the transducer was moved cephalad and the suprascapular fossa was identified, and then the transducer was moved lateral to locate the suprascapular notch. The suprascapular nerve was a round hyperechoic structure beneath the transverse scapular ligament in the scapular notch. 3 ml lidocaine 1% was injected at puncture site then the needle was inserted along the longitudinal axis of the ultrasound beam, and 10 ml of bupivacaine 0.25% was injected.
Other Names:
  • group SSNB

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
visual analogue score
Time Frame: Postoperative pain was assessed using VAS at Postoperative care unit, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, and 24hours after block administration postoperatively
The visual analogue score (VAS) was used (0 indicating no pain and 10 indicating worst unbearable pain) at rest and upon flexion for assessment of pain intensity upon arrival to the PACU
Postoperative pain was assessed using VAS at Postoperative care unit, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, and 24hours after block administration postoperatively

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
Patient satisfaction
Time Frame: 24 hours postoperatively
Patient satisfaction was evaluated using 5-point Likert scale) (1=extremely dissatisfied; 5=extremely satisfied)
24 hours postoperatively

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.
Benha University

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: Ramy Saleh, MD, Anesthesia and surgical ICU department, Faculty of Medicine, Benha University, Egypt

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.
January 26, 2023

Primary Completion (Actual)

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.
March 28, 2024

Study Completion (Actual)

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.
April 4, 2024

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 24, 2024

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.
May 1, 2024

First Posted (Estimated)

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.
May 2, 2024

Study Record Updates

Last Update Posted (Estimated)

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 2, 2024

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 1, 2024

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, 2024

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.
  • RC 16-1-2024

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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