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

NCT ID: NCT04183244

Last Updated: 2020-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-15

Study Completion Date

2021-02-15

Brief Summary

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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

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Conditions

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Postoperative Pain Shoulder Pain

Keywords

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Erector Spinae Plane Block Infraclavicular Subomohyoid Block Shoulder Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Erector spinae block

Intervention Type PROCEDURE

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 block

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

Group Type ACTIVE_COMPARATOR

Infraclavicular subomohyoid (ISO) block

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Randa Ali Shoukry

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Randa Ali Shoukry

Cairo, Al-Nozha, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Randa A Shoukry

Role: CONTACT

Phone: 002 01001404426

Email: [email protected]

Mona R Hosny

Role: CONTACT

Phone: 002 01001540563

Email: [email protected]

Facility Contacts

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Randa A Shoukry, MD

Role: primary

Mona R Hosny, MD

Role: backup

Other Identifiers

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FMASU R 57/2019

Identifier Type: -

Identifier Source: org_study_id