ClinicalTrials.gg
Status unknownNCT06674551Updated Nov 5, 2024

Suprascapular and Axillary Versus Interscalene Blocks Regarding Phrenic Affection in Shoulder Surgeries

An interventional study of Suprascapular nerve block and Axillary nerve block and Interscalene Nerve Block in Interscalene Nerve Block, Suprascapular Nerve and Shoulder Surgery, sponsored by Ain Shams University. Status unknown. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-11-05.

Sponsored by Ain Shams University · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Sep 2024), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

This study is aims to compare between combined suprascapular and axillary nerve blocks versus interscalene nerve block regarding phrenic nerve affection assessed by ultrasound guided diaphragmatic excursion in shoulder arthroscopy surgeries.

Read the detailed description

Interscalene approach of brachial plexus nerve block is recognized as the gold standard technique for postoperative pain control after shoulder arthroscopy surgeries . However, it is associated with major adverse effects and possibly critical complications including phrenic nerve affection. Combined suprascapular and axillary nerve blocks are considered to be a safe and effective alternative to interscalene nerve block for shoulder surgery. Futher studies had been done regarding postoperative analgesia after shoulder arthroscopy surgeries using intersalene nerve block versus suprascapular and axillary nerve blocks.

In this study, we will Compare between combined suprascapular and axillary nerve blocks vs interscalene nerve block regarding objective phrenic nerve affection known as a serious complication of interscalene nerve block.

02

Conditions studied

  • Interscalene Nerve Block
  • Suprascapular Nerve
  • Shoulder Surgery

Keywords

  • interscalene nerve block
  • axillary nerve block
  • shoulder surgery
03

In context

Lead sponsor

Ain Shams University is the lead sponsor of 1,932 studies on the registry; 433 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients aged between 18 - 60 years old.
  • Both sexes.
  • ASA physical status classes I - II.
  • Body mass index: 18-35 kg/ m2.

Exclusion criteria

Exclusion Criteria:

  • Infection at site of injection.
  • Psychiatric illness.
  • Central Nervous System Diseases like (epilepsy, stroke …etc.) or neurological disease affecting patient's upper limb.
  • Dependence on opiates and psycho-dynamic medications.
  • Moderate to severe pulmonary disease.
  • Coagulopathy and bleeding disorders.
  • Allergies to drug used (Bupivacaine 0.5%).
  • Previous surgery at site of injection and history of radiotherapy.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Suprascapular nerve block and Axillary nerve block ( Group A)

    Patients will receive Suprascapular nerve block (SSNB) and Axillary nerve block (AXNB) 30 minutes before the induction of general anaesthesia.

    Procedure: Suprascapular nerve block and Axillary nerve block

  • Experimental
    Interscalene nerve block (Group B)

    Patients will receive Interscalene nerve block (ISB) 30 minutes before the induction of general anaesthesia.

    Procedure: Interscalene Nerve Block

Interventions

  • ProcedureSuprascapular nerve block and Axillary nerve block

    A linear ultrasound probe will be placed in a sagittal plane at the superior medial border of the scapula. The probe will be moved laterally and then placed parallel to the scapular spine. when the needle tip contacts the bone just medial to the spinoglenoid notch and after confirmation of absence of vascular structure by color Doppler, 10 ml of 0.5% bupivacaine will be injected with aspiration every 3 ml to avoid intravascular injection and the spread of the local anaesthetic

  • ProcedureInterscalene Nerve Block

    The ultrasound probe will be placed in the supraclavicular fossa in a transverse orientation, aimed caudad into the thoracic cavity, to visualize the brachial plexus near the subclavian artery. Once identified, the plexus will be followed cephalad where it is found within the brachial plexus fascial sheath in the interscalene groove.

06

What researchers measure

Primary outcomes

  1. incidence of hemidiaphragmatic paralysis measured by ultrasound.

    defined as a ≥ 25% reduction in diaphragmatic excursion measured by ultrasound.

    Time frame: measurement will be taken 8 hours after the performance of the block for fourth and last time.

Secondary outcomes

  1. postoperative pain using NRS

    is to measure first rescue analgesia postoperative (24 hours)

    Time frame: 24 hours postoperative

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2024; primary completion for Oct 2025, 10 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 1, 2024
First posted
Nov 5, 2024
StartEst.
Nov 20, 2024
Primary completionEst.
Oct 1, 2025
CompletionEst.
Nov 1, 2025
Last update
Nov 5, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06674551
Responsible party
Sponsor
First posted
Nov 5, 2024
Start date
Nov 20, 2024 (estimated)
Primary completion
Oct 1, 2025 (estimated)
Completion
Nov 1, 2025 (estimated)
Last update
Nov 5, 2024

Study contacts

Mohamed Khaled Mahmoud, Master
Contact
midoabbas2019@gmail.com
+201211880428

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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