NCT04709211

Brief Summary

Fractures of the femur are common orthopaedic emergency especially in the geriatric population and central neuraxial blocks are the preferred technique for providing anaesthesia. However, limb immobility and extreme pain are the deterrents for ideal positioning for these procedures. postoperative pain is a nightmare so adequate analgesia has been advocated to reduce the pain. in this study, Facia Iliaca compartment block will be compared to anterior Quadratus lumborum block, both will be done Ultrasound-guided using Bupivacain0.25% for postoperative analgesia at the end of the surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable postoperative-pain

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

January 10, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 14, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

October 9, 2024

Status Verified

October 1, 2024

Enrollment Period

6 months

First QC Date

January 7, 2021

Last Update Submit

October 5, 2024

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • first request of analgesia

    the time the patient felt pain and asked for analgesics

    48 hours postoperative

Secondary Outcomes (1)

  • total opioid consumption

    48 hours postoperative

Study Arms (2)

Group I: Facia Iliaca block

ACTIVE COMPARATOR

patients will receive Ultrasound-guided Facia Iliaca Block using bupivacaine 0.25%

Procedure: Facia Iliaca block

Group Q: Anterior Quadratus lumbroum block

ACTIVE COMPARATOR

patients will receive Ultrasound-guided Anterior Quadratus Lumbroum block using bupivacaine 0.25%

Procedure: Anterior Quadratus Lumbroum blockDrug: bupivacaine

Interventions

Facia Iliaca blockPROCEDURE

patients will receive Ultrasound-guided Facia Iliaca block using 50 ml 0f Bupivacaine 0.25%

Group I: Facia Iliaca block
Anterior Quadratus Lumbroum blockPROCEDURE

patients will receive Ultrasound-guided Anterior Quadratus Lumbroum block using 50 ml 0f Bupivacaine 0.25%

Group Q: Anterior Quadratus lumbroum block
bupivacaineDRUG

bupivacaine

Group Q: Anterior Quadratus lumbroum block

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA II to IV
  • Both sexes
  • scheduled for fracture femur surgeries

You may not qualify if:

  • patients with bleeding disorders and coagulopathy
  • infection at the injection site
  • known allergy to local anaesthetics
  • patients with multiple fractures
  • patients with pre-existing myopathy or neuropathy
  • patients with significant cognitive dysfunction
  • patients who receive long-acting opioids preoperatively

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Abassia, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Fathy M Tash, MD

    Ain Shams University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of Anaesthesia

Study Record Dates

First Submitted

January 7, 2021

First Posted

January 14, 2021

Study Start

January 10, 2021

Primary Completion

June 30, 2021

Study Completion

July 1, 2021

Last Updated

October 9, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)