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

NCT06407544 | Not Yet Recruiting

• 1 other identifier: Soh-Med-24-04-07MD
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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\[24\].

Conditions

Pain and Cognitive Dysfunction Management in Hip Surgery

Outcome Measures

Primary Outcomes (2)

• VAS score

  measure pain intensity (0-10)with scores ranging from 0 (no pain) to 10 (the worst possible pain).

  2 years

• MOCA score

  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

Study Arms (3)

Group (Q):

ACTIVE COMPARATOR

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; Drug: PCA device as rescue medication with IV morphine 1mg if VAS more than 4

Group (F):

ACTIVE COMPARATOR

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; Drug: PCA device as rescue medication with IV morphine 1mg if VAS more than 4

Group (C):

ACTIVE COMPARATOR

including 20 patients with hip fractures will receive ultrasound scanning for QLB or FIB with saline injection \[26\].

Procedure: peripheral nerve block; Drug: PCA device as rescue medication with IV morphine 1mg if VAS more than 4

Interventions

peripheral nerve block PROCEDURE

peripheral nerve block guided by ultra sound through Ultrasound-guided quadratus lumborum block versus FICB or fascia iliaca block

Group (C):; Group (F):; Group (Q):

PCA device as rescue medication with IV morphine 1mg if VAS more than 4 DRUG

PCA device as rescue medication with IV morphine 1mg if VAS more than 4 with a 10 min lock-out time

Group (C):; Group (F):; Group (Q):

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sohag University: lead

Related Publications (4)

• Dhanwal DK, Dennison EM, Harvey NC, Cooper C. Epidemiology of hip fracture: Worldwide geographic variation. Indian J Orthop. 2011 Jan;45(1):15-22. doi: 10.4103/0019-5413.73656.

  PMID: 21221218 BACKGROUND

• Yucuma D, Riquelme I, Avellanal M. Painful Total Hip Arthroplasty: A Systematic Review and Proposal for an Algorithmic Management Approach. Pain Physician. 2021 May;24(3):193-201.

  PMID: 33988938 BACKGROUND

• Uzoigwe CE, O'Leary L, Nduka J, Sharma D, Melling D, Simmons D, Barton S. Factors associated with delirium and cognitive decline following hip fracture surgery. Bone Joint J. 2020 Dec;102-B(12):1675-1681. doi: 10.1302/0301-620X.102B12.BJJ-2019-1537.R3.

  PMID: 33249907 BACKGROUND

• Baeriswyl M, Kirkham KR, Kern C, Albrecht E. The Analgesic Efficacy of Ultrasound-Guided Transversus Abdominis Plane Block in Adult Patients: A Meta-Analysis. Anesth Analg. 2015 Dec;121(6):1640-54. doi: 10.1213/ANE.0000000000000967.

  PMID: 26397443 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Morphine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Central Study Contacts

Hassan A Mohammed, assistant lecutrer

CONTACT

01012323073; hassan.emara@med.sohag.edu.eg

El Hadad A Moussa, professor

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecteurer anaethesia and ICU and pain management department sohag univerisity hospital

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 9, 2024
• Study Start: May 1, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 9, 2024

Record last verified: 2024-05