NCT06311630

Brief Summary

To study the analgesic effect of ultrasound guided PENG Block vs Femoral nerve block in patients with Hip fracture presenting to Emergency department

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
recruiting

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

May 20, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2025

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

1.7 years

First QC Date

March 8, 2024

Last Update Submit

March 13, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Comparative Study of Analgesic Effect of Ultrasound Guided PENG Block With FEMORAL NERVE BLOCK in Patients With Hip Fracture as assessed by NRS pain scoring scale by patient

    To study the analgesic effect of peng block vs Femoral nerve block in patients with Hip fracture by NRS (NUMERIC RATING SCALE FROM 0-10) WITH 0 MEANING NO PAIN AND 10 MEANING SEVERE PAIN

    1 hour

Secondary Outcomes (4)

  • Time taken for each technique

    1 hour

  • Time taken for adequate analgesia

    1hour

  • Incidence of complications

    7 days

  • To note if rescue analgesic is required

    1 hour

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with Hip fracture presenting to Emergency department

You may qualify if:

  • Adults more than or equal to 18 yrs with Hip fracture
  • patients who consent for procedure

You may not qualify if:

  • history of allergy to local anaesthetics
  • pregnant or lactating women
  • infection or burns at injection site
  • patients with polytrauma
  • patients with hemodynamic instability
  • patients with low GCS
  • patients on anticoagulant or hematological disorders
  • injuries with neurovascular compromise on affected limb
  • patients with distorted anatomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jubilee mission medical College and research centre

Thrissur, Kerala, 680005, India

RECRUITING

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Jogi Varghese, MBBS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jogi Varghese, MBBS

CONTACT

Rajeev P.C, MBBS MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Junior resident

Study Record Dates

First Submitted

March 8, 2024

First Posted

March 15, 2024

Study Start

May 20, 2023

Primary Completion

January 20, 2025

Study Completion

March 20, 2025

Last Updated

March 15, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations