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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04183244
• Other study ID #: FMASU R 57/2019
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: August 15, 2019
• Est. completion date: February 15, 2021

Study information

• Verified date: December 2020
• Source: Ain Shams University
• Contact: Randa A Shoukry
• Phone: 002 01001404426
• Email: randa_shoukry[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: February 15, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Pain
• Shoulder Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Randa Ali Shoukry	Cairo	Al-Nozha

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The block efficacy	Percentage of 24 hours pain free patients	24 hours
Secondary	The incidence of expected complications ( Block safety)	The incidence of expected complications such as phrenic nerve palsy or pneumothorax.	24 hours