NCT05705128

Brief Summary

There is a high incidence reaching up to 45%; of severe intraoperative and postoperative pain associated with arthroscopic shoulder surgery, which is often significant enough to interfere with initial recovery and rehabilitation.Various peripheral nerve blocks have been used to reduce intraoperative anesthetic requirements to improve rapid recovery and reduce postoperative pain.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 30, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2025

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2025

Completed
Last Updated

May 21, 2025

Status Verified

November 1, 2024

Enrollment Period

1.8 years

First QC Date

January 21, 2023

Last Update Submit

May 19, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • numerical rating pain scale

    graded from 0 to 10 (0 = no pain, 10 = the worst possible pain)

    24 hours

Secondary Outcomes (1)

  • complications

    24 hours

Study Arms (2)

dexamethasone group

ACTIVE COMPARATOR

patients will receive dexamethasone with bupivacaine before general anaesthesia

Drug: Dexmedetomidine

dexmedetomidine group

ACTIVE COMPARATOR

patients will receive dexemedetomidine with bupivacaine before general anaesthesia

Drug: Dexmedetomidine

Interventions

Dexmedetomidine will be given with bupivaciane for postoperative pain control

dexamethasone groupdexmedetomidine group

Eligibility Criteria

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

You may qualify if:

  • Patients undergoing elective shoulder arthroscopy under general anesthesia

You may not qualify if:

  • Contraindications to regional block (coagulopathy, infection at the needle insertion site, or diaphragmatic paralysis).
  • Altered conscious level.
  • Pregnancy. .Body mass index (BMI \> 35).
  • Patients who have difficulty understanding the study protocol
  • Patients who have any known contraindication to study medications
  • Patient refusal.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospital

Asyut, 71516, Egypt

Location

MeSH Terms

Conditions

Agnosia

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • ahmed abdelsabour, lecturer

    Assiut University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

January 21, 2023

First Posted

January 30, 2023

Study Start

August 1, 2023

Primary Completion

May 15, 2025

Study Completion

May 20, 2025

Last Updated

May 21, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations