Prospective Comparative Study Between Ultrasound-guided Quadratus Lumborum Block Versus Fascia Iliaca Compartment Block for Postoperative Pain and Cognitive Dysfunction Management in Patient Undergoing Hip Surgery

May 7, 2024 updated by: Hassan Ahmed Mohamed, Sohag University

Hip fractures are more common in older people due to osteoporosis. It is estimated that around six million patients worldwide will suffer hip fractures annually by 2050 as the population ages [1]. Clinically, hip surgery is a common and effective treatment for hip fractures. There will be an increasing number of older people undergoing hip surgery, including osteosynthesis and arthroplasty. However, severe surgical trauma, postoperative pain, and postoperative cognitive dysfunction (POCD) can be a considerable challenge for older people undergoing hip surgery [2, 3].The successful use of QLB with all approaches has been reported in case reports for the following surgical procedures: proctosigmoidectomy, hip surgery, above-knee amputation, abdominal hernia repair, breast reconstruction, colostomy, closure, radical nephrectomy, lower extremity vascular surgery, total hip arthroplasty, laparotomy, and colectomy.

Ultrasound-guided quadratus lumborum block (QLB) is a recently described fascial plane block in which the anesthetic is injected adjacently to the quadratus lumborum (QL) muscle with the goal of anesthetizing the nerves in the thoracolumbar region [17,18]. As a trunk nerve block, quadratus lumborum block (QLB) has been widely used for postoperative analgesia in patients undergoing abdominal and lower limb surgeries [19].

QLB can provide adequate analgesia and reduce opioid requirements after hip surgery [20]FICB or fascia iliaca block (FIB), first proposed in 1989, is a means ofblocking the three principal lumbar plexus nerves of the thigh with a single injection of local anesthetic delivered immediately dorsal to the fascia iliaca [21,22]. Indications of FICB are surgical anesthesia to the lower extremity, management of cancer pain and pain owing to inflammatory conditions of the lumbar plexus, and amelioration of acute pain following trauma, fracture, and burn [23]. Fascia Iliaca Block (FIB), which is widely used for postoperative analgesia in hip surgery, is a nerve block technique with proven efficacy[24].

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: El Hadad A Moussa, professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

age > 65 years ASA 1 , ASA 2 Montreal Cognitive Assessment (MoCA) score ≥ 26 before surgery scheduled for hip surgery

Exclusion Criteria:

patient refusal History of chronic pain or daily use of analgesics History of psychiatric disorder or inability to understand the consent form or how to use a visual analog scale (VAS) for pain measurement inability to communicate appropriately Allergy to any required drugs alcohol abuse Local infection at the injection site contraindications to neuraxial anesthesia long-term use of antidepressants or narcotic analgesics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group (Q):
including 20 patients with hip fractures will undergo ultrasound guided anterior QLB, will be administered 0.3 ml/kg of 0.125% bupivacaine (containing 1 mic/ml of dexmedetomidine and 5 mg of dexamethasone).
Procedure: peripheral nerve block
peripheral nerve block guided by ultra sound through Ultrasound-guided quadratus lumborum block versus FICB or fascia iliaca block
Drug: PCA device as rescue medication with IV morphine 1mg if VAS more than 4
PCA device as rescue medication with IV morphine 1mg if VAS more than 4 with a 10 min lock-out time
Active Comparator: Group (F):
including 20 patients with hip fractures will undergo ultrasound guided FIB, will be administered 0.3 ml/kg of 0.125% bupivacaine (containing 1 mic/ml of dexmedetomidine and 5 mg of dexamethasone).
Procedure: peripheral nerve block
peripheral nerve block guided by ultra sound through Ultrasound-guided quadratus lumborum block versus FICB or fascia iliaca block
Drug: PCA device as rescue medication with IV morphine 1mg if VAS more than 4
PCA device as rescue medication with IV morphine 1mg if VAS more than 4 with a 10 min lock-out time
Active Comparator: Group (C):
including 20 patients with hip fractures will receive ultrasound scanning for QLB or FIB with saline injection [26].
Procedure: peripheral nerve block
peripheral nerve block guided by ultra sound through Ultrasound-guided quadratus lumborum block versus FICB or fascia iliaca block
Drug: PCA device as rescue medication with IV morphine 1mg if VAS more than 4
PCA device as rescue medication with IV morphine 1mg if VAS more than 4 with a 10 min lock-out time

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS score
Time Frame: 2 years
measure pain intensity (0-10)with scores ranging from 0 (no pain) to 10 (the worst possible pain).
2 years
MOCA score
Time Frame: 2 years
measure post operative cognitive dysfunctionThe MOCA scores including visuospatial ability, naming, short-term memory, attention, language, abstraction, delayed recall, and orientation. MoCA states ranges may be used to grade severity: 18-25 = mild cognitive impairment, 10-17= moderate cognitive impairment and less than 10= severe cognitive impairment.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

May 2, 2024

First Submitted That Met QC Criteria

May 7, 2024

First Posted (Actual)

May 9, 2024

Study Record Updates

Last Update Posted (Actual)

May 9, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-24-04-07MD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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