Ultrasound-guided Genicular Nerves Block | NCT05813834

Studies
Ultrasound-guided Genicular Nerves Block

NCT05813834

Sponsor

Cairo University

Status

Completed

Last Update Posted

Nov 14, 2024Actual

Enrollment

56Actual

Phase

Not Applicable

Conditions

Genicular Nerve Block for Pain in ACL Arthroscopy

Interventions

Genicular Nerves Block

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

Nov 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

Jun 1, 2023Actual

Primary Completion Date

Feb 15, 2024Actual

Completion Date

Mar 30, 2024Actual

First Submitted Date

Apr 3, 2023

First Submission Date that Met QC Criteria

Apr 3, 2023

First Posted Date

Apr 14, 2023Actual

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

Nov 12, 2024

Last Update Posted Date

Nov 14, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dalia Ismail, Associate Professor of Anesthesia, Surgical ICU and pain management at Faculty of medicine Cairo University, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

Most of arthroscopic ACL repairs are day case surgeries associated with moderate postoperative pain and discomfort. So , finding an effective and safe, analgesic technique with minimal complications is our goal for fast recovery and short hospital stay.

in this study, we aim to compare the efficacy of genicular nerve block against controls on postoperative pain scores, the need for rescue analgesics, patient's satisfaction and range of motion (ROM) after arthroscopic ACL cases.

Detailed Description

In this study, we aim to compare the efficacy of genicular nerve block against controls on postoperative pain scores, the need for rescue analgesics, patient's satisfaction and range of motion (ROM) after arthroscopic ACL cases.

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

56Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
genicular nerve block group	Active Comparator	patients will receive genicular nerves block	Procedure: Genicular Nerves Block
control group	No Intervention	patients will not receive genicular nerves block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Genicular Nerves Block	Procedure	US guided genicular nerves block	genicular nerve block group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
post operative VAS	vas score	24 hours

Secondary Outcomes

Measure	Description	Time Frame
total morphine consumption	morphine onsumpton	24 hours
time to first morphine analgesia	rescue analgesia	24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

both genders
age 18 - 65
ASA i, ii, iii

Exclusion Criteria:

ROM less than 90
advanced renal or liver diseases
patient refusal
substance abuse
site infection
known sensitivity to any of study drugs

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dalia K Ismail	Cairo University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
faculty of medicine Cairo university		Cairo			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