Fascia Iliaca Compartment Block Versus Anterior Quadratus Lumborum Block

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT04709211

Collaborator

(none)

128

Enrollment

Location

Arms

5.7

Actual Duration (Months)

22.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Procedure: Facia Iliaca block Procedure: Anterior Quadratus Lumbroum block Drug: bupivacaine	N/A

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

Study Design

Study Type:

Interventional

Actual Enrollment :

128 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

A Comparative Study Between Postoperative Analgesia of Fascia Iliaca Compartment Block and Anterior Quadratus Lumborum Block in Proximal Femur Fracture

Actual Study Start Date :

Jan 10, 2021

Actual Primary Completion Date :

Jun 30, 2021

Actual Study Completion Date :

Jul 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group I: Facia Iliaca block patients will receive Ultrasound-guided Facia Iliaca Block using bupivacaine 0.25%	Procedure: Facia Iliaca block patients will receive Ultrasound-guided Facia Iliaca block using 50 ml 0f Bupivacaine 0.25% Drug: bupivacaine bupivacaine
Active Comparator: Group Q: Anterior Quadratus lumbroum block patients will receive Ultrasound-guided Anterior Quadratus Lumbroum block using bupivacaine 0.25%	Procedure: Anterior Quadratus Lumbroum block patients will receive Ultrasound-guided Anterior Quadratus Lumbroum block using 50 ml 0f Bupivacaine 0.25% Drug: bupivacaine bupivacaine

Arm

Intervention/Treatment

Active Comparator: Group I: Facia Iliaca block

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

Procedure: Facia Iliaca block

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

Drug: bupivacaine

bupivacaine

Active Comparator: Group Q: Anterior Quadratus lumbroum block

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

Procedure: Anterior Quadratus Lumbroum block

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

Drug: bupivacaine

bupivacaine

Outcome Measures

Primary Outcome Measures

first request of analgesia [48 hours postoperative]
the time the patient felt pain and asked for analgesics

Secondary Outcome Measures

total opioid consumption [48 hours postoperative]
total dose of fentanyl used

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University	Cairo	Abassia	Egypt

Sponsors and Collaborators

Ain Shams University

Investigators

Study Chair: Fathy M Tash, MD, Ain Shams University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rania Maher Hussien, MD, Assistant professor of Anaesthesia, Ain Shams University

ClinicalTrials.gov Identifier:

NCT04709211

Other Study ID Numbers:

FMASU M D 260/2020

First Posted:

Jan 14, 2021

Last Update Posted:

Aug 5, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Bupivacaine

Study Results

No Results Posted as of Aug 5, 2022