Pain and Cognitive Dysfunction Management in Hip SurgeryNCT06407544
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
A study testing peripheral nerve block and PCA device as rescue medication with IV morphine 1mg if VAS more than 4 in people with Pain and Cognitive Dysfunction Management in Hip Surgery, run by Sohag University.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Pain and Cognitive Dysfunction Management in Hip Surgery
- What is being tested?
- peripheral nerve block and PCA device as rescue medication with IV morphine 1mg if VAS more than 4
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- May 2024to May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- age > 65 years ASA 1 , ASA 2 Montreal Cognitive Assessment (MoCA) score ≥ 26 before surgery scheduled for hip surgery
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
El Hadad A Moussa, professor contact
About this study
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].
- Being tested
- peripheral nerve block, PCA device as rescue medication with IV morphine 1mg if VAS more than 4
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peripheral nerve blockProcedure or surgery
peripheral nerve block guided by ultra sound through Ultrasound-guided quadratus lumborum block versus FICB or fascia iliaca block
PCA device as rescue medication with IV morphine 1mg if VAS more than 4Drug
PCA device as rescue medication with IV morphine 1mg if VAS more than 4 with a 10 min lock-out time
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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]. Receives: Procedure: peripheral nerve block; Drug: PCA device as rescue medication with IV morphine 1mg if VAS more than 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS score
measure pain intensity (0-10)with scores ranging from 0 (no pain) to 10 (the worst possible pain).
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study startMay 2024 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pain and Cognitive Dysfunction Management in Hip SurgeryStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hassan Ahmed Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06407544
- Sponsor's protocol ID
- Soh-Med-24-04-07MD
- Status last verified
- May 2024
- First submitted
- 2 May 2024
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 21221218Yucuma 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 33988938Uzoigwe 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 33249907Baeriswyl 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
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06407544
- Acronym / sponsor ID
- Soh-Med-24-04-07MD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- May 2024 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 9 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group (Q): | Active comparator | Procedure: peripheral nerve block, Drug: PCA device as rescue medication with IV morphine 1mg if VAS more than 4including 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). |
| Group (F): | Active comparator | Procedure: peripheral nerve block, Drug: PCA device as rescue medication with IV morphine 1mg if VAS more than 4including 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). |
| Group (C): | Active comparator | Procedure: peripheral nerve block, Drug: PCA device as rescue medication with IV morphine 1mg if VAS more than 4including 20 patients with hip fractures will receive ultrasound scanning for QLB or FIB with saline injection [26]. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- age > 65 years ASA 1 , ASA 2 Montreal Cognitive Assessment (MoCA) score ≥ 26 before surgery scheduled for hip surgery
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| peripheral nerve blockperipheral nerve block guided by ultra sound through Ultrasound-guided quadratus lumborum block versus FICB or fascia iliaca block | Procedure or surgery | Group (C):, Group (F):, Group (Q): |
| PCA device as rescue medication with IV morphine 1mg if VAS more than 4PCA device as rescue medication with IV morphine 1mg if VAS more than 4 with a 10 min lock-out time | Drug | Group (C):, Group (F):, Group (Q): |
Primary outcome
VAS score
Time frame: 2 years
measure pain intensity (0-10)with scores ranging from 0 (no pain) to 10 (the worst possible pain).
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Background: PubMed 21221218Dhanwal 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.
- Background: PubMed 33988938Yucuma 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.
- Background: PubMed 33249907Uzoigwe 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.
- Background: PubMed 26397443Baeriswyl 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
El Hadad A Moussa, professor contact
Questions about this trial
What is this clinical trial studying?
A study testing peripheral nerve block and PCA device as rescue medication with IV morphine 1mg if VAS more than 4 in people with Pain and Cognitive Dysfunction Management in Hip Surgery, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hassan A Mohammed, assistant lecutrer (01012323073, hassan.emara@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS score (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06407544, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.