Circumflex Nerve Blocks Versus Posterior Cord Nerve Blocks in Shoulder Arthroscopy

June 26, 2020 updated by: Bassant M. Abdelhamid

Analgesic Effect of Ultrasound Guided Combined (Suprascapular and Circumflex Nerve Blocks ) Versus (Suprascapular Nerve and Posterior Cord Nerve Blocks at Infraclavicular Level ) During Shoulder Arthroscopy : A Randomized Controlled Study

Shoulder arthroscopy is associated with severe postoperative pain. Traditionally, the interscalene approach to the brachial plexus has been employed to manage postoperative pain following shoulder surgery.To provide more complete shoulder joint analgesia, suprascabular nerve block (SSNB) was combined with block of the circumflex nerve which comes from the posterior cord of the brachial plexus that usually gives also upper subscapular, thoracodorsal, lower subscapular and radial nerves.

Study Overview

Status

Status

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

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Detailed Description

Aim of the work is to compare postoperative analgesic effect of ultrasound guided combined suprascapular and circumflex nerve blocks versus suprascapular nerve and posterior cord blocks at infraclavicular level .

Thirty four patients aged from 18-70 years old, with ASA physical status I-II-III and scheduled for shoulder surgeries will be included in the study. Patients will be randomly allocated using computer-generated table into one of two groups:

  • Group circumflex → will undergo ultrasound guided SSN+circumflex.
  • Group posterior cord → will undergo ultrasound guided SSN+posterior cord.

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 (Anticipated)

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.
30

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 Contact

Study Contact

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Study Contact Backup

Study Locations

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA I-II.-III
  • Undergoing shoulder arthroscopy.

Exclusion Criteria:

  • Patient refusal
  • Known allergy to local anesthetics
  • Bleeding disorders
  • Inability to provide informed consent

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 Assignment
  • Masking: Triple

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: circumflex
patients will undergo ultrasound guided SSN+circumflex
Procedure: Suprascapular Nerve Block
The patient will be put in sitting down position with upper limbs pending beside the body then a high-frequency linear ultrasound probe will be positioned transversely above the spine of the scapula. The suprascapular nerve often appears as hypereccoic structure at the suprascapular notch. A 20-gauge spinal needle will be advanced in-plane from medial to lateral 10mL of bupivacaine 0.25% into the suprascapular notch deep to the superior transverse scapular ligament (STSL) and adjacent to the suprascapular artery (SSA) .
Other Names:
  • SSN
Procedure: Axillary Nerve Block
Patient will be put in sitting position, with the shoulder in full adduction. linear transducer (8-14 MHz) will be positioned in the short axis orientation at the neck of humerous to identify the axillary artery about 1 to 3 cm from the skin surface.The artery is the most reliable landmark, then a 21-gauge 90 mm needle will be advanced in-plane and 10 mL of bupivacaine 0.25% will be injected adjacent to the artery.
Procedure: General anesthesia
General anaesthesia will be induced after giving nerve block in a standardized way with propofol 1.5-2.5mg/kg, fentanyl 2-3 µ/kg and atracurium 0.5mg/kg. maintenance of anaesthesia with isoflurane and atracurium 0.1mg/kg/20min.
Experimental: posterior cord
patients will undergo ultrasound guided SSN+circumflex
Procedure: Suprascapular Nerve Block
The patient will be put in sitting down position with upper limbs pending beside the body then a high-frequency linear ultrasound probe will be positioned transversely above the spine of the scapula. The suprascapular nerve often appears as hypereccoic structure at the suprascapular notch. A 20-gauge spinal needle will be advanced in-plane from medial to lateral 10mL of bupivacaine 0.25% into the suprascapular notch deep to the superior transverse scapular ligament (STSL) and adjacent to the suprascapular artery (SSA) .
Other Names:
  • SSN
Procedure: General anesthesia
General anaesthesia will be induced after giving nerve block in a standardized way with propofol 1.5-2.5mg/kg, fentanyl 2-3 µ/kg and atracurium 0.5mg/kg. maintenance of anaesthesia with isoflurane and atracurium 0.1mg/kg/20min.
Procedure: posterior cord block
Patient will be put in supine position with head turned away from side that will be blocked with the arm abducted 90 and flexed at the elbow then linear transducer (8-14 MHz) will be positioned in short-axis just medial to coracoid process.Once the artery will be identified, an attempt will be made to identify the hyperechoic cords of the brachial plexus and their corresponding positions relative to the artery, although these may not always be identifiable. The needle will be inserted in plane from the cephalad end of the probe. 10 mL bupivacaine 0.25% will be injected at the posterior cord.

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
Time Frame
Time of the first postoperative analgesic request
Time Frame: 12 hours postoperative
12 hours postoperative

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
Visual analogue score
Time Frame: 12 hours postoperative
visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain) and verbal pain scale (VPS )ranging from 0 to 3 (0 = no pain, 1 = mild pain, 2 = moderate pain, and 3 = severe pain).
12 hours postoperative
Total morphine consumption
Time Frame: 12 hours postoperative
12 hours postoperative

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.
Bassant M. Abdelhamid

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cairo 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: Mohamed Abd-Elraouf Nasr, Cairo university
  • Study Director: Ahmed Zaghloul, Cairo university
  • Study Director: Mohsen Waheb, Cairo university

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

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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.
June 25, 2020

Primary Completion (Anticipated)

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.
September 20, 2020

Study Completion (Anticipated)

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.
September 30, 2020

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).
June 22, 2020

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.
June 22, 2020

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.
June 24, 2020

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.
June 29, 2020

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.
June 26, 2020

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.
June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • S-10-2019

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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