NCT05796778

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

October 19, 2023

Status Verified

October 1, 2023

Enrollment Period

7 months

First QC Date

March 21, 2023

Last Update Submit

October 18, 2023

Conditions

Keywords

Interscalene brachial plexus blockshoulder painsubomohyoid plane block

Outcome Measures

Primary Outcomes (1)

  • Visual analogue pain score

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

    24 hour

Secondary Outcomes (3)

  • Time of first analgesic request

    24 hour

  • Total analgesic consumption

    24 hour

  • Incidence of any side effects

    24 hour

Study Arms (2)

subomohyoid suprascapular nerve

EXPERIMENTAL

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.

Procedure: subomohyoid plane block

Interscalene brachial plexus

ACTIVE COMPARATOR

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

Procedure: Interscalene brachial plexus block

Interventions

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

subomohyoid suprascapular nerve

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.

Interscalene brachial plexus

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 18-60 years.
  • ASA I-II.
  • Both sexes.
  • Shoulder surgery.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minia University Hospital

Minya, 61511, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, PostoperativeShoulder Pain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsArthralgiaJoint DiseasesMusculoskeletal Diseases

Study Officials

  • hassan m. hetta, lecturer

    Minia University, faculty of medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

hassan m. hetta, lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anesthesia and ICU

Study Record Dates

First Submitted

March 21, 2023

First Posted

April 4, 2023

Study Start

April 1, 2023

Primary Completion

November 1, 2023

Study Completion

December 1, 2023

Last Updated

October 19, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations