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

Primary Purpose

Post-operative Pain Management, Hip Fracture Surgery

Status
Completed
Phase
Phase 2
Locations
Pakistan
Study Type
Interventional
Intervention
PENG block
FICB Block
Sponsored by
Pain Medicine Department
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-operative Pain Management

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pain Medicine Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

PENG Block Group

FICB Group

Arm Description

Outcomes

Primary Outcome Measures

Pain score using Numeric Rating scale
Pain scored assessed after completion of surgery at one, six, eighteen and twenty fours

Secondary Outcome Measures

Total Tramadol consumption
Total Tramadol consumption In twenty four hours

Full Information

First Posted
March 30, 2023
Last Updated
March 30, 2023
Sponsor
Pain Medicine Department
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1. Study Identification

Unique Protocol Identification Number
NCT05810012
Brief Title
Comparison of Analgesic Efficacy of PENB Block With FICB in Post Operative Hip Fracture Patients
Official Title
Comparison of Analgesic Efficacy of Ultrasound Guided Pericapsular Nerve Group Block Versus Fascia Iliaca Compartment Block in Patients of Hip Fracture
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
October 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pain Medicine Department

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain Management, Hip Fracture Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PENG Block Group
Arm Type
Experimental
Arm Title
FICB Group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
PENG block
Intervention Description
10ml of 0.125% isobaric bupivacaine injected
Intervention Type
Drug
Intervention Name(s)
FICB Block
Intervention Description
20ml of 0.125% isobaric bupivacaine injected
Primary Outcome Measure Information:
Title
Pain score using Numeric Rating scale
Description
Pain scored assessed after completion of surgery at one, six, eighteen and twenty fours
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Total Tramadol consumption
Description
Total Tramadol consumption In twenty four hours
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moazzam Ali
Organizational Affiliation
Pain Medicine Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pain Medicine Department
City
Lahore
Country
Pakistan

12. IPD Sharing Statement

Learn more about this trial

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

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