Postoperative Analgesic Efficacy of Pericapsular Nerve Gr... | NCT04738500

Studies
Postoperative Analgesic Efficacy of Pericapsular Nerve Group Block (PENG) Block for Knee Arthroscopy

NCT04738500

Sponsor

Bora Bilal

Status

Unknown status

Last Update Posted

Apr 14, 2021Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Postoperative Pain

Interventions

PENG Block combinated with PCA
PCA

Countries

Turkey (Türkiye)

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

Apr 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 15, 2021Estimated

Primary Completion Date

May 30, 2021Estimated

Completion Date

Jun 15, 2021Estimated

First Submitted Date

Feb 1, 2021

First Submission Date that Met QC Criteria

Feb 1, 2021

First Posted Date

Feb 4, 2021Actual

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

Apr 13, 2021

Last Update Posted Date

Apr 14, 2021Actual

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

Pericapsular nerve group block (PENG) has been deemed as a safe and effective regional technique for postoperative pain after knee arthroscopy.

Detailed Description

Pericapsular nerve group block(PENG) has been deemed as a safe and effective regional technique for postoperative pain after knee artroscopy. Blockade of the branches of the femoral and obturator nerves that provide innervation to any structures distal enough to be useful in knee.

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

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PENG Block	Active Comparator	PENG Block combinate with PCA	Procedure: PENG Block combinated with PCA
CONTROL	Sham Comparator	PCA	Procedure: PCA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PENG Block combinated with PCA	Procedure	After spinal anesthesia PENG block will be performed	PENG Block

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
First analgesic demand	The time interval from PENG blocks to the first analgesic demand.	24 Hours

Secondary Outcomes

Measure	Description	Time Frame
Opioid consumption	Total opioid analgesic consumption	24 Hours
Numeric Rating Scale	The maximum score on a 10cm numeric rating scale: (0 to 10cm) (0 = no pain, 10 = worst imaginable pain)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients agreed to receive PENG block
Knee arthroscopy

Exclusion Criteria:

Other kinds of knee surgery
Patients refuse to receive PENG block

Accepts Healthy Volunteers

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

Name	Role	Phone	Extension	Email
Bora Bilal, Assos. Prof.	Contact	05052354430		bilalbora@yahoo.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
KSU Faculty of Medicine Research Hospital		Kahramanmaraş		46200	Turkey (Türkiye)

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
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
D010323	Passive Cutaneous Anaphylaxis

Ancestor Terms

ID	Term
D012882	Skin Tests
D007159	Immunologic Tests
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided