PENG and LFCN Block Versus Lumbar Plexus Block for Postop... | NCT05652075

Studies
PENG and LFCN Block Versus Lumbar Plexus Block for Postoperative Analgesia After Total Hip Arthroplasty

NCT05652075

Sponsor

Minia University

Status

Unknown status

Last Update Posted

Oct 19, 2023Actual

Enrollment

66Estimated

Phase

Not Applicable

Conditions

Post Operative Pain
Regional Block

Interventions

pericapsular nerve group and lateral femoral cutaneous nerve block
lumbar plexus 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

Oct 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2023Actual

Primary Completion Date

Jan 1, 2024Estimated

Completion Date

Feb 1, 2024Estimated

First Submitted Date

Dec 7, 2022

First Submission Date that Met QC Criteria

Dec 7, 2022

First Posted Date

Dec 15, 2022Actual

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

Oct 18, 2023

Last Update Posted Date

Oct 19, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hassan Mokhtar Elshorbagy Hetta, lecturer of anesthesia and ICU, Minia UniversityPrincipal Investigator

Lead Sponsor

Minia UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Regional anesthesia for postoperative analgesia in THA includes epidural anesthesia and peripheral nerve blocks. However epidural anesthesia has a great role in THA, it has become restricted as perioperative antithrombotic drugs are generally used for orthopedic patients.

the study aim to evaluate and compare efficacy and safety of pericapsular nerve group block (PENG) block and lateral femoral cutaneous nerve versus Lumbar plexus block on postoperative analgesia in hip surgery.

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

66Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PENG and LFCN	Experimental		Procedure: pericapsular nerve group and lateral femoral cutaneous nerve block
lumbar plexus	Experimental		Procedure: lumbar plexus block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pericapsular nerve group and lateral femoral cutaneous nerve block	Procedure	Will undergo pericapsular nerve group block (PENG) combined with lateral femoral cutaneous nerve under ultrasound guided block with 20 mL of 0.25% bupivacaine.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual analogue scale pain scores	pain score from 0-10 which 0 mean no pain and 10 the worst pain	24 hour

Secondary Outcomes

Measure	Description	Time Frame
first analgesic request	time to demand nalbuphine	24 hour
total analgesic consumption	total nalbuphine in mg consumed in the first day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

(ASA) physical status I to III scheduled for hip surgery aged (30-70) years

Exclusion Criteria:

Drug allergy,
Morbid obesity (BMI >40 kg/m2),
Coagulopathy,
Psychiatric disorder,
Opioid dependence,
Patient refusal to give informed consent.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
hassan m. hetta, lecturer	Contact	1010901114	0020	hassan.hetta@mu.edu.eg

Overall Officials

Name	Affiliation	Role
hassan m. hetta, lecturer	Minia University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Minia University	Recruiting	Minya	Minya Governorate	61511	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
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