NCT07046325

Brief Summary

Comparison between dexametidomedine\\bupivacaine and plain bupivacaine in superior trunk block for arthroscopic shoulder surgeries

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 20, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2025

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 1, 2025

Completed
Last Updated

July 1, 2025

Status Verified

May 1, 2025

Enrollment Period

3 months

First QC Date

June 15, 2025

Last Update Submit

June 29, 2025

Conditions

Post Operative Pain, AcuteArthroscopic Shoulder Surgery

Outcome Measures

Primary Outcomes (1)

  • Duration of analgesia of Superior trunck block.

    The DOA will be defined as the time interval between STB and the first need for the rescue analgesics.

    24 hours

Study Arms (2)

group B

ACTIVE COMPARATOR

group administered Ultrasound guided STB with bupivacaine

Drug: Bupivacain

group DB

ACTIVE COMPARATOR

group administered Ultrasound guided STB with bupivacaine and dexametidomedine.

Drug: dexametedomidineDrug: Bupivacain

Interventions

dexametedomidineDRUG

1\. Group DB: are administered Ultrasound guided STB with bupivacaine and dexametidomedine.

group DB
BupivacainDRUG

2\. Group B: are administered Ultrasound guided STB with bupivacaine.

group Bgroup DB

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age ;20-50 years old
  • Both genders
  • American Society of Anesthesiologists physical status I and II
  • BMI less than 30
  • Arthroscopic shoulder surgeries.

You may not qualify if:

  • Patients with ASA more than II
  • Patients with a sepsis, malignancy anywhere
  • Patient with bleeding tendencies or on anticoagulation therapy
  • Patients with pre-existing neurologic deficit or neuropathy affecting brachial plexus
  • Allergy to study drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Egypt, 00202, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • fagr fathy abdo, Medical Doctorate

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2025

First Posted

July 1, 2025

Study Start

January 20, 2025

Primary Completion

April 20, 2025

Study Completion

May 1, 2025

Last Updated

July 1, 2025

Record last verified: 2025-05

Locations

EG(1)