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

Phase 1

• Conditions: Postoperative Pain; Shoulder Pain
• Interventions: Procedure: Infraclavicular subomohyoid (ISO) block; Procedure: Erector spinae block

• Registration Number: NCT04183244
• Lead Sponsor: Ain Shams University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-15
• Study First Submitted: 2019-11-27
• Study First Submitted QC: 2019-12-02
• Study First Posted: 2019-12-03
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-13
• Last Update Posted: 2020-12-16
• Primary Completion: 2021-01-15
• Study Completion: 2021-02-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
infraclavicular subomohyoid block	Infraclavicular subomohyoid (ISO) block	Performing posterior approach infraclavicular BP block followed by subomohioid block via the same puncture site under ultrasound guidance.
Erector spinae block	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

Primary Outcome Measures

Name	Time	Method
The block efficacy	24 hours	Percentage of 24 hours pain free patients

Secondary Outcome Measures

Name	Time	Method
The incidence of expected complications ( Block safety)	24 hours	The incidence of expected complications such as phrenic nerve palsy or pneumothorax.

Trial Locations

Locations (1)

Randa Ali Shoukry; 🇪🇬 Cairo, Al-Nozha, Egypt