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

NCT04183244 | Unknown Phase 1

• 1 other identifier: FMASU R 57/2019
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain; Shoulder Pain

Keywords

Erector Spinae Plane Block; Infraclavicular Subomohyoid Block; Shoulder Surgery

Outcome Measures

Primary Outcomes (1)

• The block efficacy

  Percentage of 24 hours pain free patients

  24 hours

Secondary Outcomes (1)

• The incidence of expected complications ( Block safety)

  24 hours

Study Arms (2)

Erector spinae block

ACTIVE COMPARATOR

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

infraclavicular subomohyoid block

ACTIVE COMPARATOR

Performing posterior approach infraclavicular BP block followed by subomohioid block via the same puncture site under ultrasound guidance.

Procedure: Infraclavicular subomohyoid (ISO) block

Interventions

Erector spinae block PROCEDURE

A 5-cm needle prick in the back of the patient 3 cm lateral to mid-line under sterile conditions, with ultrasound guidance.

Erector spinae block

Infraclavicular subomohyoid (ISO) block PROCEDURE

Under complete aseptic precaution, 12 cm needle will be inserted 2cm superior to the clavicle and advanced retroclavicular, with ultrasound guidance.

infraclavicular subomohyoid block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Randa Ali Shoukry

Cairo, Al-Nozha, 11843, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Shoulder Pain

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Arthralgia; Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Central Study Contacts

Randa A Shoukry

CONTACT

002 01001404426; randa_shoukry@hotmail.com

Mona R Hosny

CONTACT

002 01001540563; monamourmar@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 27, 2019
• First Posted: December 3, 2019
• Study Start: August 15, 2019
• Primary Completion: January 15, 2021
• Study Completion: February 15, 2021
• Last Updated: December 16, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)