NCT05810012

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 12, 2023

Completed
Last Updated

February 12, 2025

Status Verified

March 1, 2023

Enrollment Period

7 months

First QC Date

March 30, 2023

Last Update Submit

February 8, 2025

Conditions

Post-operative Pain ManagementHip Fracture Surgery

Outcome Measures

Primary Outcomes (1)

  • Pain score using Numeric Rating scale

    Pain scored assessed after completion of surgery at one, six, eighteen and twenty fours

    24 hours

Secondary Outcomes (1)

  • Total Tramadol consumption

    24 hours

Study Arms (2)

PENG Block Group

EXPERIMENTAL
Drug: PENG block

FICB Group

EXPERIMENTAL
Drug: FICB Block

Interventions

PENG blockDRUG

10ml of 0.125% isobaric bupivacaine injected

PENG Block Group
FICB BlockDRUG

20ml of 0.125% isobaric bupivacaine injected

FICB Group

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • surgical correction of fracture neck of femur under spinal anaesthesia

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pain Medicine Department

Lahore, Pakistan

Location

Study Officials

  • Moazzam Ali

    Pain Medicine Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Pain Specialist

Study Record Dates

First Submitted

March 30, 2023

First Posted

April 12, 2023

Study Start

April 1, 2022

Primary Completion

October 31, 2022

Study Completion

October 31, 2022

Last Updated

February 12, 2025

Record last verified: 2023-03

Locations

PA(1)