NCT04669639

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

December 20, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2021

Completed
Last Updated

May 24, 2022

Status Verified

November 1, 2020

Enrollment Period

9 months

First QC Date

November 25, 2020

Last Update Submit

May 22, 2022

Conditions

Keywords

erector spinae plane block- suprascapular nerve

Outcome Measures

Primary Outcomes (1)

  • Intraoperative analgesia

    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

Study Arms (3)

The block group (a)

EXPERIMENTAL

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.

Other: Block procedures for shoulder surgery analgesia

The block group (b)

EXPERIMENTAL

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.

Other: Block procedures for shoulder surgery analgesia

control group

PLACEBO COMPARATOR

Patients were randomized in a 1:1:1 ratio. this group will receive general anesthesia (GA) only

Other: Block procedures for shoulder surgery analgesia

Interventions

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

The block group (a)The block group (b)control group

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Zagazig University

Zagazig, 44519, Egypt

Location

Related Publications (4)

  • Urmey WF, Talts KH, Sharrock NE. One hundred percent incidence of hemidiaphragmatic paresis associated with interscalene brachial plexus anesthesia as diagnosed by ultrasonography. Anesth Analg. 1991 Apr;72(4):498-503. doi: 10.1213/00000539-199104000-00014.

    PMID: 2006740BACKGROUND
  • Ma W, Sun L, Ngai L, Costouros JG, Steffner R, Boublik J, Tsui BCH. Motor-sparing high-thoracic erector spinae plane block for proximal humerus surgery and total shoulder arthroplasty surgery: clinical evidence for differential peripheral nerve block? Can J Anaesth. 2019 Oct;66(10):1274-1275. doi: 10.1007/s12630-019-01442-4. Epub 2019 Jul 9. No abstract available.

    PMID: 31290120BACKGROUND
  • Hussain N, Goldar G, Ragina N, Banfield L, Laffey JG, Abdallah FW. Suprascapular and Interscalene Nerve Block for Shoulder Surgery: A Systematic Review and Meta-analysis. Anesthesiology. 2017 Dec;127(6):998-1013. doi: 10.1097/ALN.0000000000001894.

    PMID: 28968280BACKGROUND
  • Abdelhaleem NF, Abdelatiff SE, Abdel Naby SM. Comparison of Erector Spinae Plane Block at the Level of the Second Thoracic Vertebra With Suprascapular Nerve Block for Postoperative Analgesia in Arthroscopic Shoulder Surgery. Pain Physician. 2022 Nov;25(8):577-585.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
The care provider and outcome assessor will be unaware of the study design
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: There has been a recent renewed interest in using the suprascapular nerve block (SSNB) as a phrenic nerve sparing approach for analgesia after shoulder surgery. The suprascapular nerve provides 70% of the sensory input to the glenohumeral joint and also innervates the infraspinatus and supraspinatus muscles. However, some researchers suggest that SSNB alone cannot provide a sufficient analgesia.The high-thoracic erector spinae plane block (HT-ESPB) has been described in several case reports as an effective analgesic modality for the shoulder region without causing motor or phrenic nerve block
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, Anesthesia and Surgical Intensive Care department, Faculty of Medicine

Study Record Dates

First Submitted

November 25, 2020

First Posted

December 17, 2020

Study Start

December 20, 2020

Primary Completion

September 10, 2021

Study Completion

November 10, 2021

Last Updated

May 24, 2022

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
once the paper is published and become available online
Access Criteria
for all anaesthesiologists
More information

Locations