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

Primary Purpose

Postoperative Pain, Shoulder Pain

Status
Unknown status
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Erector spinae block
Infraclavicular subomohyoid (ISO) block
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Erector Spinae Plane Block, Infraclavicular Subomohyoid Block, Shoulder Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Randa Ali ShoukryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Erector spinae block

infraclavicular subomohyoid block

Arm Description

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

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

Outcomes

Primary Outcome Measures

The block efficacy
Percentage of 24 hours pain free patients

Secondary Outcome Measures

The incidence of expected complications ( Block safety)
The incidence of expected complications such as phrenic nerve palsy or pneumothorax.

Full Information

First Posted
November 27, 2019
Last Updated
December 13, 2020
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04183244
Brief Title
Efficacy of Erector Spinae Plane Block Versus Infraclavicular Subomohyoid Block in Shoulder Surgery
Official Title
Efficacy of Erector Spinae Plane Block Versus Infraclavicular Subomohyoid Block in Shoulder Surgery: A Randomized Controlled Blinded Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 15, 2019 (Actual)
Primary Completion Date
January 15, 2021 (Anticipated)
Study Completion Date
February 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Shoulder Pain
Keywords
Erector Spinae Plane Block, Infraclavicular Subomohyoid Block, Shoulder Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Erector spinae block
Arm Type
Active Comparator
Arm Description
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
Arm Title
infraclavicular subomohyoid block
Arm Type
Active Comparator
Arm Description
Performing posterior approach infraclavicular BP block followed by subomohioid block via the same puncture site under ultrasound guidance.
Intervention Type
Procedure
Intervention Name(s)
Erector spinae block
Intervention Description
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
Intervention Name(s)
Infraclavicular subomohyoid (ISO) block
Intervention Description
Under complete aseptic precaution, 12 cm needle will be inserted 2cm superior to the clavicle and advanced retroclavicular, with ultrasound guidance.
Primary Outcome Measure Information:
Title
The block efficacy
Description
Percentage of 24 hours pain free patients
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
The incidence of expected complications ( Block safety)
Description
The incidence of expected complications such as phrenic nerve palsy or pneumothorax.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Randa A Shoukry
Phone
002 01001404426
Email
randa_shoukry@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mona R Hosny
Phone
002 01001540563
Email
monamourmar@hotmail.com
Facility Information:
Facility Name
Randa Ali Shoukry
City
Cairo
State/Province
Al-Nozha
ZIP/Postal Code
11843
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Randa A Shoukry, MD
Phone
01001404426
Email
randa_shoukry@hotmail.com
First Name & Middle Initial & Last Name & Degree
Mona R Hosny, MD
Phone
01001540563
Email
monamourmar@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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