A Comparison of ESP Block to SSN Block for Analgesia in Shoulder Surgery

May 22, 2022 updated by: Naglaa Fathy Abdelhaleem Abdelhaleem, Zagazig University

A Comparison of Erector Spinae Plane Block to Suprascapular Nerve Block for Analgesia in Shoulder Surgery

A comparison between Erector Spinae Plane block and Suprascapular nerve block in providing analgesia for shoulder surgery

Study Overview

Detailed Description

Suprascapular nerve block is considered a phrenic nerve sparing approach that recently introduced as alternative for interscalene brachial plexus nerve block in shoulder surgery. However, some researchers reported that Suprascapular nerve block alone results in an ineffective analgesia. Erector Spinae Plane block is supposed to be able in providing adequate analgesia in shoulder surgery

Study Type

Interventional

Enrollment (Actual)

96

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

      • Zagazig, Egypt, 44519
        • Faculty of medicine, Zagazig 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

Ages Eligible for Study

21 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA I and II,
  • Age above 21 years and below 60 years in both sexes,
  • Cooperative patients,
  • Patients with a BMI (body mass index) not exceeding 35.

Exclusion Criteria:

  • patients with cardiovascular or respiratory compromise,
  • Patient refusal,
  • Coagulopathy,
  • Local tissue infection,
  • Allergy to local anesthesia,
  • prior to cervical or thoracic spine 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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The block group (a)
Patients were randomized in a 1:1 :1ratio, group (a) will receive SSN. The nerve blocks The procedure will be performed after induction of anaesthesia and endotracheal intubation.

The patients in group (a) will be placed in lateral decubitus. Then, an ultrasound-guided aseptic technique with a high-frequency linear transducer will be used to locate the transverse process of T2, where a needle will be inserted in a cephalocaudal direction until reaching the space between the fascia of the erector spinae and the transverse process of T2 and 30 ml of local anesthetic of bupivacaine 0.5% will be injected.

  • In group (b), SSC nerve block will be done as follow: In the suprascapular notch, an ultrasound-guided aseptic technique with a high-frequency linear transducer will be used. The linear probe, enveloped in a sterile sheath, will be placed parallel to the spine of the scapula to visualize it and then will be moved cephalic to the supraspinatus fossa. The probe will then be moved laterally up to the scapular notch, where the nerve will be identified by its round hyperechogenic shape 4 cm deep.
  • control group: patients will receive only general anesthesia
Experimental: The block group (b)
Patients were randomized in a 1:1:1 ratio. group (b) will receive the Erector spinae plane block. The procedure will be performed after induction of anesthesia and endotracheal intubation.

The patients in group (a) will be placed in lateral decubitus. Then, an ultrasound-guided aseptic technique with a high-frequency linear transducer will be used to locate the transverse process of T2, where a needle will be inserted in a cephalocaudal direction until reaching the space between the fascia of the erector spinae and the transverse process of T2 and 30 ml of local anesthetic of bupivacaine 0.5% will be injected.

  • In group (b), SSC nerve block will be done as follow: In the suprascapular notch, an ultrasound-guided aseptic technique with a high-frequency linear transducer will be used. The linear probe, enveloped in a sterile sheath, will be placed parallel to the spine of the scapula to visualize it and then will be moved cephalic to the supraspinatus fossa. The probe will then be moved laterally up to the scapular notch, where the nerve will be identified by its round hyperechogenic shape 4 cm deep.
  • control group: patients will receive only general anesthesia
Placebo Comparator: control group
Patients were randomized in a 1:1:1 ratio. this group will receive general anesthesia (GA) only

The patients in group (a) will be placed in lateral decubitus. Then, an ultrasound-guided aseptic technique with a high-frequency linear transducer will be used to locate the transverse process of T2, where a needle will be inserted in a cephalocaudal direction until reaching the space between the fascia of the erector spinae and the transverse process of T2 and 30 ml of local anesthetic of bupivacaine 0.5% will be injected.

  • In group (b), SSC nerve block will be done as follow: In the suprascapular notch, an ultrasound-guided aseptic technique with a high-frequency linear transducer will be used. The linear probe, enveloped in a sterile sheath, will be placed parallel to the spine of the scapula to visualize it and then will be moved cephalic to the supraspinatus fossa. The probe will then be moved laterally up to the scapular notch, where the nerve will be identified by its round hyperechogenic shape 4 cm deep.
  • control group: patients will receive only general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative analgesia
Time Frame: The intraoperative patients' hemodynamics every 30 min were collected and analyzed till the end of surgery . Also the total dose of opioids consumed intraoperatively will be recorded. Postoperative consumed opioid for 24 hours also will calculated
Recording of the patients' hemodynamics (heart rate and non-invasive blood pressure) and total dose of opioids consumption intraoperatively and postoperatively.
The intraoperative patients' hemodynamics every 30 min were collected and analyzed till the end of surgery . Also the total dose of opioids consumed intraoperatively will be recorded. Postoperative consumed opioid for 24 hours also will calculated

Collaborators and Investigators

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

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.

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)

December 20, 2020

Primary Completion (Actual)

September 10, 2021

Study Completion (Actual)

November 10, 2021

Study Registration Dates

First Submitted

November 25, 2020

First Submitted That Met QC Criteria

December 9, 2020

First Posted (Actual)

December 17, 2020

Study Record Updates

Last Update Posted (Actual)

May 24, 2022

Last Update Submitted That Met QC Criteria

May 22, 2022

Last Verified

November 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • #6506

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The data will be available when the study is finished and the paper is published

IPD Sharing Time Frame

once the paper is published and become available online

IPD Sharing Access Criteria

for all anaesthesiologists

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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