NCT06262893

Brief Summary

In this study the investigators aim to compare the effect of the suprascapular- supraclavicular nerve block in association with dexamethasone to that of the interscalene brachial plexus block on analgesic effect during arthroscopic shoulder surgery, as postoperative pain scores ,postoperative consumption of analgesic rescue medications and diaphragmatic excursion assessment.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

December 26, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 16, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

February 25, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

April 22, 2025

Status Verified

February 1, 2025

Enrollment Period

1.8 years

First QC Date

December 26, 2023

Last Update Submit

April 17, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postoperative analgesia by visual analog scale (VAS).

    The primary outcome of this study will be to evaluate and compare between suprascapular-supraclavicular nerve block in association with dexamethasone to that of the interscalene brachial plexus block on postoperative analgesia by vas score during 48h postoperatively ( 2h , 6h , 12h, 24h and 48h). The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').

    48 hours

Secondary Outcomes (1)

  • Diaphragmatic excursion

    1hour postoperatively

Study Arms (2)

Interscalene block in shoulder arthroscopy

ACTIVE COMPARATOR
Procedure: Shoulder arthroscopy blocks

Combined Supraclavicular block and suprascapular block in shoulder arthroscopy

ACTIVE COMPARATOR
Procedure: Shoulder arthroscopy blocks

Interventions

Effect of dexamethasone adjuvant in combined supraclavicular block and suprascapular block versus Interscalene block in patients undergoing shoulder arthroscopy.

Combined Supraclavicular block and suprascapular block in shoulder arthroscopyInterscalene block in shoulder arthroscopy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA status 1,2.
  • Age 18 years or older
  • Elective shoulder arthroscopic surgery under general anesthesia and nerve block performed preoperatively.

You may not qualify if:

  • Patient refusal
  • Serious cardiac arrhythmias (including atrial fibrillation) or unstable coronary artery disease.
  • Use of drugs that act on the autonomic nervous system (including β- blockers).
  • Coagulation disorders..
  • Anatomical disorders and/or neuropathic disease.
  • BMI above 40.
  • History of substance abuse.
  • Chronic use of psychotropic and/or opioid.
  • History of psychiatric diseases needing treatment.
  • Allergy to any drug in the study protocol.
  • Failure of nerve block performed in the preoperative block room when tested prior to entering the operating room (i.e. lack of loss of sensation to ice at the shoulder incision level).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Egypt

RECRUITING

Central Study Contacts

Mohamed Talaat

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 26, 2023

First Posted

February 16, 2024

Study Start

February 25, 2024

Primary Completion

December 1, 2025

Study Completion

January 1, 2026

Last Updated

April 22, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations