search
Back to results

Sub Omohyoid Suprascapular Nerve Block Versus Interscalene Nerve Block

Primary Purpose

Post Operative Pain, Regional Anesthesia, Nerve Block

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
subomohyoid plane block
Interscalene brachial plexus block
Sponsored by
Minia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Operative Pain focused on measuring Interscalene brachial plexus block, shoulder pain, subomohyoid plane block

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Aged 18-60 years. ASA I-II. Both sexes. Shoulder surgery. Exclusion Criteria: Patient refusal Allergy to local anesthetics BMI >40 kg/m2 Bleeding diathesis or history of anticoagulant use. Psychiatric diseases. Infection of the skin at the site of needle punctures area.

Sites / Locations

  • Minia University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

subomohyoid suprascapular nerve

Interscalene brachial plexus

Arm Description

superficial probe of ultrasound was placed in the transverse plane to visualize the superior trunk in the short axis. The suprascapular nerve was identified as it branched off from the superior trunk and traced until it coursed beneath the inferior belly of the omohyoid muscle.

ultrasound-guided interscalene block involves imaging the C5 and C6 roots at approximately the level of the cricoid cartilage, just distal to where they emerge from behind their respective transverse processes and where they lie in the groove between the anterior and middle scalene muscles

Outcomes

Primary Outcome Measures

Visual analogue pain score
pain score from 0 to 10 which mean 0 no pain and 10 the worst pain ever

Secondary Outcome Measures

Time of first analgesic request
the time of first demand rescue analgesia
Total analgesic consumption
total fentanyl demand
Incidence of any side effects
oxygen desaturation, pneumothorax, dyspnea, and phrenic nerve palsy, block, and opioid-related side effects

Full Information

First Posted
March 21, 2023
Last Updated
October 18, 2023
Sponsor
Minia University
search

1. Study Identification

Unique Protocol Identification Number
NCT05796778
Brief Title
Sub Omohyoid Suprascapular Nerve Block Versus Interscalene Nerve Block
Official Title
Sub Omohyoid Suprascapular Nerve Block Versus Interscalene Nerve Block for Postoperative Shoulder Surgery Pain: Randomized Comparative Study.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Shoulder surgery can be very painful surgery after which the use of opioids is often required. The well-known side-effects of opioids (e.g. respiratory depression, somnolence, nausea, vomiting, and pruritus) limit their use in so called 'fast track' surgery and anaesthesia programmes. the study aimed to compare the effect of sub omohyoid suprascapular nerve block versus interscalene nerve block in preventing postoperative pain and decreasing analgesic consumption in patients scheduled for shoulder surgery

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain, Regional Anesthesia, Nerve Block
Keywords
Interscalene brachial plexus block, shoulder pain, subomohyoid plane block

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
subomohyoid suprascapular nerve
Arm Type
Experimental
Arm Description
superficial probe of ultrasound was placed in the transverse plane to visualize the superior trunk in the short axis. The suprascapular nerve was identified as it branched off from the superior trunk and traced until it coursed beneath the inferior belly of the omohyoid muscle.
Arm Title
Interscalene brachial plexus
Arm Type
Active Comparator
Arm Description
ultrasound-guided interscalene block involves imaging the C5 and C6 roots at approximately the level of the cricoid cartilage, just distal to where they emerge from behind their respective transverse processes and where they lie in the groove between the anterior and middle scalene muscles
Intervention Type
Procedure
Intervention Name(s)
subomohyoid plane block
Intervention Description
The block needle was inserted in line with the probe in a lateral-to-medial orientation toward the suprascapular nerve. Local anesthetic solution was then injected after negative aspiration for blood to achieve circumferential spread around the neurovascular bundle
Intervention Type
Procedure
Intervention Name(s)
Interscalene brachial plexus block
Intervention Description
The block needle is usually advanced in plane in a lateral-to-medial direction through the middle scalene muscle to contact the nerve roots and inject local anesthetic around them.
Primary Outcome Measure Information:
Title
Visual analogue pain score
Description
pain score from 0 to 10 which mean 0 no pain and 10 the worst pain ever
Time Frame
24 hour
Secondary Outcome Measure Information:
Title
Time of first analgesic request
Description
the time of first demand rescue analgesia
Time Frame
24 hour
Title
Total analgesic consumption
Description
total fentanyl demand
Time Frame
24 hour
Title
Incidence of any side effects
Description
oxygen desaturation, pneumothorax, dyspnea, and phrenic nerve palsy, block, and opioid-related side effects
Time Frame
24 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18-60 years. ASA I-II. Both sexes. Shoulder surgery. Exclusion Criteria: Patient refusal Allergy to local anesthetics BMI >40 kg/m2 Bleeding diathesis or history of anticoagulant use. Psychiatric diseases. Infection of the skin at the site of needle punctures area.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
hassan m. hetta, lecturer
Phone
1010901114
Ext
0020
Email
hassan.hetta@mu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hassan m. hetta, lecturer
Organizational Affiliation
minia university/ faculty of medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Minia University Hospital
City
Minya
ZIP/Postal Code
61511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
hassan m. hetta, lecturer
Phone
1010901114
Ext
0020
Email
hassan.hetta@mu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Sub Omohyoid Suprascapular Nerve Block Versus Interscalene Nerve Block

We'll reach out to this number within 24 hrs