Dexmedetomidine in Sonographic Guided Erector Spinae Plan... | NCT06899841

Studies
Dexmedetomidine in Sonographic Guided Erector Spinae Plane Block

NCT06899841

Sponsor

Assiut University

Status

Recruiting

Last Update Posted

Mar 28, 2025Actual

Enrollment

90Estimated

Phase

Phase 2Phase 3

Conditions

Pain Management

Interventions

Dexmedetomidine

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2024Actual

Primary Completion Date

Oct 1, 2025Estimated

Completion Date

Apr 1, 2026Estimated

First Submitted Date

Mar 16, 2025

First Submission Date that Met QC Criteria

Mar 21, 2025

First Posted Date

Mar 28, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 21, 2025

Last Update Posted Date

Mar 28, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

to investigate the postoperative analgesic effect of dexmedetomidine addition with different doses as an adjuvant to bupivacaine to Erector spinae plane block after renal surgeries.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
low dose dex	Experimental	0.5 mic/kg of dexmedetomidine administered	Drug: Dexmedetomidine
intermediate dose dex	Experimental	0.75 mic/kg of dexmedetomidine administered	Drug: Dexmedetomidine
high dose dex	Experimental	1 mic/kg of dexmedetomidine administered	Drug: Dexmedetomidine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexmedetomidine	Drug	different doses of dexmedetomidine added to bupivacaine in erector spinae plane block	high dose dex intermediate dose dex low dose dex

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
postoperative analgesic duration	postoperative analgesic duration with each dose	24 hours

Secondary Outcomes

Measure	Description	Time Frame
Pain score	severity of pain using visual analogue pain score	24 hours
side effects	as hemodynamic effect as (hypotension, bradycardia), nausea and vomiting.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age between 18 and 70 years.
Both sexes, males and females.
Patients with the American Society of Anesthesiologists (ASA) physical status I/II.
Body mass index (BMI) of 18-35 kg/m2
Patients scheduled for elective Renal or Percutaneous Nephrolithotomy.

Exclusion Criteria:

Patients under 18 years.
Patient refusal of nerve block.
Infection at the site of injection.
Coagulopathy.
Allergy to used medications.
Psychiatric disorder or chronic pain syndromes.
Chronic opioid use or substance abuse.
Quadriplegic patients.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assiut University Hospitals	Recruiting	Asyut	Assiut Governorate	71111	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000377	Agnosia

Ancestor Terms

ID	Term
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020927	Dexmedetomidine

Ancestor Terms

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided