Efficacy of Erector Spinae Plane Block Versus Infraclavicular Subomohyoid Block in Shoulder Surgery

Efficacy of Erector Spinae Plane Block Versus Infraclavicular Subomohyoid Block in Shoulder Surgery: A Randomized Controlled Blinded Study

The study aimed to compare Erector Spinae Plane (ESP) block versus infraclavicular subomohyoid (ISO) block in the provision of efficacy of either technique in postoperative analgesia in shoulder surgery, aiming to testing the safety of each block in terms of incidence of complications. Patients will be randomly divided into two groups, Group E will receive Erector spinae block and group I will receive infraclavicular subomohyioid block. The local anesthetic solution that will be used in both blocks will be a total volume of 30 mls 0.25%bupivacaine plus 3mg preservative free Dexamethasone. The time between recovery from anesthesia and first pain experienced, as verified by NRS ≥ 3 and first need of a rescue analgesic, will be defined as the duration of analgesia. The total dose of intravenous morphine (the rescue analgesic) used over 24 h postoperatively will be recorded.

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain; Shoulder Pain
• Intervention / Treatment: Procedure: Erector spinae block; Procedure: Infraclavicular subomohyoid (ISO) block

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Al-Nozha
    • Cairo, Al-Nozha, Egypt, 11843
      • Recruiting
      • Randa Ali Shoukry
      • Contact: Randa A Shoukry, MD; Phone Number: 01001404426; Email: randa_shoukry@hotmail.com
      • Contact: Mona R Hosny, MD; Phone Number: 01001540563; Email: monamourmar@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patients, above 18 years old.
• ASA physical status I
• Scheduled for shoulder surgery

Exclusion Criteria:

• Morbid obese.
• Previous surgery in the same shoulder.
• History of psychiatric disorder.
• Pulmonary disease.
• Contraindication to regional nerve block (e.g. skin infection at the puncture site, coagulopathy).
• Allergy to any of medications that will be used

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Erector spinae block; Ultrasound guidance will be used to visualize the transverse processes of T2 and the overlying muscles. Under sterile conditions, a 5-cm, 21-gauge needle will be inserted using the out-of-plane technique parallel to the sagittal plane directly over the transverse process,then 30mL of the local anesthetic solution will be injected and observed for the linear spread of LA the under direct ultrasound visualization	Procedure: Erector spinae block; A 5-cm needle prick in the back of the patient 3 cm lateral to mid-line under sterile conditions, with ultrasound guidance.
Active Comparator: infraclavicular subomohyoid block; Performing posterior approach infraclavicular BP block followed by subomohioid block via the same puncture site under ultrasound guidance.	Procedure: Infraclavicular subomohyoid (ISO) block; Under complete aseptic precaution, 12 cm needle will be inserted 2cm superior to the clavicle and advanced retroclavicular, with ultrasound guidance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The block efficacy	Percentage of 24 hours pain free patients	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of expected complications ( Block safety)	The incidence of expected complications such as phrenic nerve palsy or pneumothorax.	24 hours

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2019
• Primary Completion (Anticipated): January 15, 2021
• Study Completion (Anticipated): February 15, 2021

Study Registration Dates

• First Submitted: November 27, 2019
• First Submitted That Met QC Criteria: December 2, 2019
• First Posted (Actual): December 3, 2019

Study Record Updates

• Last Update Posted (Actual): December 16, 2020
• Last Update Submitted That Met QC Criteria: December 13, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Shoulder Surgery; Erector Spinae Plane Block; Infraclavicular Subomohyoid Block
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain
• Other Study ID Numbers: FMASU R 57/2019

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
• product manufactured in and exported from the U.S.: No