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Not yet recruitingNCT06407544Updated May 9, 2024

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

An interventional study of peripheral nerve block and PCA device as rescue medication with IV morphine 1mg if VAS more than 4 in Pain and Cognitive Dysfunction Management in Hip Surgery, sponsored by Sohag University. Not yet recruiting. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2024-05-09.

Sponsored by Sohag University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2026, 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
65 Years and older
Sex
All
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Study 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].

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Conditions studied

  • Pain and Cognitive Dysfunction Management in Hip Surgery
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In context

Cognitive Dysfunction

3,842 studies on the registry are indexed under Cognitive Dysfunction; 1,099 are open to participants now.

This study's planned enrollment of 60 is close to the median of 65 across 2,807 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

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

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

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

Interventions

  • Procedureperipheral nerve block

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

  • DrugPCA 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

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What researchers measure

Primary outcomes

  1. VAS score

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

    Time frame: 2 years

  2. 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.

    Time frame: 2 years

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 21221218 ↗
  • 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. PubMed 33988938 ↗
  • 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. PubMed 33249907 ↗
  • 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. PubMed 26397443 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06407544
Lead sponsor
Sohag University
Responsible party
Hassan Ahmed Mohamed (assistant lecteurer anaethesia and ICU and pain management department sohag univerisity hospital, Sohag University) — Principal investigator
First posted
May 9, 2024
Start date
May 2024 (estimated)
Primary completion
May 2026 (estimated)
Completion
May 2026 (estimated)
Last update
May 9, 2024

Study contacts

Hassan A Mohammed, assistant lecutrer
Contact
hassan.emara@med.sohag.edu.eg
01012323073
El Hadad A Moussa, professor
Contact

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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