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Fascia Iliaca Compartment Block Versus Anterior Quadratus Lumborum Block

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Facia Iliaca block
Anterior Quadratus Lumbroum block
bupivacaine
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Ain Shams University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group I: Facia Iliaca block

Group Q: Anterior Quadratus lumbroum block

Arm Description

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

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

Outcomes

Primary Outcome Measures

first request of analgesia
the time the patient felt pain and asked for analgesics

Secondary Outcome Measures

total opioid consumption
total dose of fentanyl used

Full Information

First Posted
January 7, 2021
Last Updated
August 4, 2022
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04709211
Brief Title
Fascia Iliaca Compartment Block Versus Anterior Quadratus Lumborum Block
Official Title
A Comparative Study Between Postoperative Analgesia of Fascia Iliaca Compartment Block and Anterior Quadratus Lumborum Block in Proximal Femur Fracture
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 10, 2021 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
July 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
In this prospective, randomized, comparative study patients will be equally divided into two equal groups; GroupI: patients will receive Ultrasound-guided Facia Iliaca compartment block with 50 ml 0.25%bupivacaine at the end of surgery Group Q: patients will receive Ultrasound-guided anterior Quadratus lumborum block with 50 ml 0.25%bupivacaine at the end of surgery

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I: Facia Iliaca block
Arm Type
Active Comparator
Arm Description
patients will receive Ultrasound-guided Facia Iliaca Block using bupivacaine 0.25%
Arm Title
Group Q: Anterior Quadratus lumbroum block
Arm Type
Active Comparator
Arm Description
patients will receive Ultrasound-guided Anterior Quadratus Lumbroum block using bupivacaine 0.25%
Intervention Type
Procedure
Intervention Name(s)
Facia Iliaca block
Intervention Description
patients will receive Ultrasound-guided Facia Iliaca block using 50 ml 0f Bupivacaine 0.25%
Intervention Type
Procedure
Intervention Name(s)
Anterior Quadratus Lumbroum block
Intervention Description
patients will receive Ultrasound-guided Anterior Quadratus Lumbroum block using 50 ml 0f Bupivacaine 0.25%
Intervention Type
Drug
Intervention Name(s)
bupivacaine
Intervention Description
bupivacaine
Primary Outcome Measure Information:
Title
first request of analgesia
Description
the time the patient felt pain and asked for analgesics
Time Frame
48 hours postoperative
Secondary Outcome Measure Information:
Title
total opioid consumption
Description
total dose of fentanyl used
Time Frame
48 hours postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: ASA II to IV Both sexes scheduled for fracture femur surgeries Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fathy M Tash, MD
Organizational Affiliation
Ain Shams University
Official's Role
Study Chair
Facility Information:
Facility Name
Ain Shams University
City
Cairo
State/Province
Abassia
Country
Egypt

12. IPD Sharing Statement

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Fascia Iliaca Compartment Block Versus Anterior Quadratus Lumborum Block

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