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

Phase 1

• Conditions: Postoperative Pain; Shoulder Pain

• 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

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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