Dexamethasone Versus Demedetomidine Addition for Adductor... | NCT06527976

Studies
Dexamethasone Versus Demedetomidine Addition for Adductor Canal Block

NCT06527976

Sponsor

Assiut University

Status

Completed

Last Update Posted

Jul 30, 2024Actual

Enrollment

90Actual

Phase

Not Applicable

Conditions

Postoperative Pain

Interventions

Dexmedetomidine
Dexamethasone

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

Jul 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 15, 2022Actual

Primary Completion Date

Jan 1, 2024Actual

Completion Date

Jan 1, 2024Actual

First Submitted Date

Jul 26, 2024

First Submission Date that Met QC Criteria

Jul 26, 2024

First Posted Date

Jul 30, 2024Actual

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

Jul 26, 2024

Last Update Posted Date

Jul 30, 2024Actual

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

Single-injection peripheral nerve block (PNB) is commonly used for perioperative analgesia and anesthesia. Three approaches for extending the duration of PNB include continuous PNB with catheter-based techniques, novel local anesthetics delivery systems and addition of novel adjuvants to local anesthetics.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
dexmedetomidine	Active Comparator		Drug: Dexmedetomidine
dexamethasone	Active Comparator		Drug: Dexamethasone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexmedetomidine	Drug	dexmedetomedine added to bupivacaine for adductor canal block	dexmedetomidine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
visual analogue scale score	scale of 11 points. zero=no pain, 10 = worest pain ever	24 hours postoperative

Secondary Outcomes

Measure	Description	Time Frame
analgesia duration	pain free duration after block	24 hours postoperative
opioid consumption	amount of opioid consumed postoperative

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

elective operation
ASA STATUS I and II

Exclusion Criteria:

patient refusal
ASA status III and IV
contraindications to local anesthesia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Assiut university		Asyut		71111	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020927	Dexmedetomidine
D003907	Dexamethasone

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided