Comparison of Analgesic Efficacy of PENB Block with FICB... | NCT05810012

Studies
Comparison of Analgesic Efficacy of PENB Block with FICB in Post Operative Hip Fracture Patients

NCT05810012

Sponsor

Pain Medicine Department

Status

Completed

Last Update Posted

Feb 12, 2025Actual

Enrollment

50Actual

Phase

Phase 2

Conditions

Post-operative Pain Management
Hip Fracture Surgery

Interventions

PENG block
FICB Block

Countries

Pakistan

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 2023

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

Apr 1, 2022Actual

Primary Completion Date

Oct 31, 2022Actual

Completion Date

Oct 31, 2022Actual

First Submitted Date

Mar 30, 2023

First Submission Date that Met QC Criteria

Mar 30, 2023

First Posted Date

Apr 12, 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

Feb 8, 2025

Last Update Posted Date

Feb 12, 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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study was done to evaluate two different interventions for postoperative pain control in patients undergoing hip surgeries. Fifty patients, divided in two equal groups, were included in the study. Patients in Group P were given pericapsular nerve group (PENG) block while those in Group F were given fascia iliaca compartment block (FICB). Pain score, using Numeric Rating scale as a measurement tool, was assessed at one, six, eighteen and twenty fours after the procedure as a primary outcome. Total tramadol consumption in milligrams was recorded as a secondary outcome.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PENG Block Group	Experimental		Drug: PENG block
FICB Group	Experimental		Drug: FICB Block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PENG block	Drug	10ml of 0.125% isobaric bupivacaine injected	PENG Block Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain score using Numeric Rating scale	Pain scored assessed after completion of surgery at one, six, eighteen and twenty fours	24 hours

Secondary Outcomes

Measure	Description	Time Frame
Total Tramadol consumption	Total Tramadol consumption In twenty four hours	24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

surgical correction of fracture neck of femur under spinal anaesthesia

Exclusion Criteria:

allergy to local anaesthetics
bleeding disorders
morbid obesity with BMI more than 35
patients of chronic pain
drug addiction
psychiatric issues

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

Not provided

Overall Officials

Name	Affiliation	Role
Moazzam Ali	Pain Medicine Department	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pain Medicine Department		Lahore			Pakistan