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
About this trial
This is an interventional treatment trial for Post-operative Pain Management
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
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
NCT ID
NCT05810012
First Posted
March 30, 2023
Last Updated
March 30, 2023
Sponsor
Pain Medicine Department
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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