Cognitive DeclineNCT03794427
Combined Lumbosacral Nerve Block Versus Spinal Anesthesia for Cognitive Function After Hip Prothesis
A study testing unilateral lumbosacral nerve block and Spinal anesthesia in people with Cognitive Decline, run by Makassed General Hospital at 1 site in Lebanon.
Trial summary
Hip fracture is a potentially devastating event, and serious surgical and medical complications occur frequently especially for elderly patients. Delirium is one of the common complications after hip surgery. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cognitive Decline
- What is being tested?
- unilateral lumbosacral nerve block and Spinal anesthesia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteLebanon
- Study dates
- 2 Jan 2019to Apr 2022
- 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
- Admitted with a hip fracture (femoral neck, trochanteric or sub-trochanteric)
- 40 kg in weight and higher
Who cannot join
- Patients who are:
- Uncooperative
- Considered as moribund by the orthopedic surgeon at admission
- Alzheimer
- Severe cognitive impairment (MMSE<18)
- Absolute contraindication for spinal anesthesia (assessed preoperatively)
- Allergy to local anesthesia
Trial locations and contacts
1 site in 1 country.
Lebanon1 site, 1 recruiting
- Recruiting
Makassed General Hospital
Beirut
Zoher Naja, MD, +9611636000 ext. 6941, zouhnaja@yahoo.com
About this study
Official title: Cognitive Changes After Hip Prosthesis; Comparison Between Combined Lumbosacral Nerve Block Versus Spinal Anesthesia: a Double Blind Randomized Clinical Trial
Hip fracture is a potentially devastating event, and serious surgical and medical complications occur frequently especially for elderly patients. Delirium is one of the common complications after hip surgery. Controversy exists regarding the possible impact of type of anesthesia (nerve block versus spinal) upon acute and long-term cognitive decline.
The primary objective is to assess the association between type of anesthesia (nerve block vs. spinal anesthesia) and risk of cognitive decline (CD). The secondary objective is to compare intra-operative hemodynamic changes, use of vasopressor drugs, and use of post-operative analgesics with respect to the type of anesthesia.
Prospective, double blind randomized clinical trial of hip fracture patients who will be assessed for CD pre- and postoperatively, using the Mini Mental State Examination (MMSE). The presence of CD will be determined at follow-up evaluation up to three months after surgery.
Read the detailed description
Prospective, double blind randomized clinical trial of hip fracture patients who will be assessed for CD pre- and postoperatively, using the Mini Mental State Examination (MMSE). The presence of CD will be determined at follow-up evaluation up to three months after surgery. Patients undergoing hip surgery will be randomized into two groups. Group 1 will receive unilateral lumbosacral nerve block (sciatic nerve block and paravertebral block at levels L3-L4 and L4-L5) as well as placebo injection (1 ml normal saline) at the spinal anesthesia level (L3-L4 or L4-L5). The sciatic nerve will be injected by 20 ml of the anesthetic mixture whereas levels L3-L4 and L4-L5 will be injected by a total of 20 ml of the anesthetic mixture without exceeding the maximum injected volume of 1 ml/kg. Group 2 will receive spinal anesthesia (3 ml of 0.5% bupivacaine) in addition to placebo injection at the sciatic, L3-L4 and L4-L5 levels.
- Conditions
- Cognitive Decline
- Being tested
- unilateral lumbosacral nerve block, Spinal anesthesia, Placebo at the spinal anesthesia level, Placebo at lumbosacral level
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
unilateral lumbosacral nerve blockOther
Patients will receive unilateral lumbosacral nerve block (sciatic nerve block and paravertebral block at levels L3-L4 and L4-L5). The sciatic nerve will be injected by 20 ml of the anesthetic mixture whereas levels L3-L4 and L4-L5 will be injected by a total of 20 ml of the anesthetic mixture without exceeding the maximum injected volume of 1 ml/kg.
Spinal anesthesiaOther
Patients will receive spinal anesthesia (3 ml of 0.5% bupivacaine)
Placebo at the spinal anesthesia levelOther
Patients will receive 1 ml normal saline at the spinal anesthesia level (L3-L4 or L4-L5).
Placebo at lumbosacral levelOther
Patients will receive normal saline at the sciatic, L3-L4 and L4-L5 levels
| Study group | Role | What they receive |
|---|---|---|
| unilateral lumbosacral nerve block | Experimental | Sciatic nerve block and paravertebral block at levels L3-L4 and L4-L5 will be performed Receives: Other: unilateral lumbosacral nerve block; Other: Placebo at the spinal anesthesia level |
| Spinal anesthesia | Active comparator | spinal anesthesia will be performed Receives: Other: Spinal anesthesia; Other: Placebo at lumbosacral level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive decline
Patients' cognitive function will be assessed using the Mini Mental State Examination. The total score ranges between 0 and 30. A total score between 24 and 30 indicates no cognitive impairment. A score between 18 and 23 indicates mild cognitive impairment. A score between 0 and 17 indicates severe cognitive impairment
Measured: before operation (baseline)
Cognitive decline
Patients' cognitive function will be assessed using the Mini Mental State Examination. The total score ranges between 0 and 30. A total score between 24 and 30 indicates no cognitive impairment. A score between 18 and 23 indicates mild cognitive impairment. A score between 0 and 17 indicates severe cognitive impairment
Measured: 1 day after the operation
Cognitive decline
Patients' cognitive function will be assessed using the Mini Mental State Examination. The total score ranges between 0 and 30. A total score between 24 and 30 indicates no cognitive impairment. A score between 18 and 23 indicates mild cognitive impairment. A score between 0 and 17 indicates severe cognitive impairment
Measured: 7 days after the operation
Cognitive decline
Patients' cognitive function will be assessed using the Mini Mental State Examination. The total score ranges between 0 and 30. A total score between 24 and 30 indicates no cognitive impairment. A score between 18 and 23 indicates mild cognitive impairment. A score between 0 and 17 indicates severe cognitive impairment
Measured: 1 month after the operation
Cognitive decline
Patients' cognitive function will be assessed using the Mini Mental State Examination. The total score ranges between 0 and 30. A total score between 24 and 30 indicates no cognitive impairment. A score between 18 and 23 indicates mild cognitive impairment. A score between 0 and 17 indicates severe cognitive impairment
Measured: 2 months after the operation
Cognitive decline
Patients' cognitive function will be assessed using the Mini Mental State Examination. The total score ranges between 0 and 30. A total score between 24 and 30 indicates no cognitive impairment. A score between 18 and 23 indicates mild cognitive impairment. A score between 0 and 17 indicates severe cognitive impairment
Measured: 3 months after operation
Secondary outcomes (3)
Intra-operative hemodynamic changes
Mean arterial pressure (in mmHg) will be recorded through a questionnaire
Measured: 1 minute intra-operative
Intra-operative hemodynamic changes
Mean arterial pressure (in mmHg) will be recorded through a questionnaire
Measured: 5 minutes intra-operative
Intra-operative hemodynamic changes
Mean arterial pressure (in mmHg) will be recorded through a questionnaire
Measured: every 10 minutes intra-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study start2 Jan 2019
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeclineStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Makassed General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zoher Naja, Makassed General Hospital
- Investigators
- Zoher Naja, Principal investigator, Makassed General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03794427
- Sponsor's protocol ID
- 181218
- Status last verified
- Jan 2022
- First submitted
- 25 Dec 2018
- Last updated
- 18 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Changes After Hip Prosthesis; Comparison Between Combined Lumbosacral Nerve Block Versus Spinal Anesthesia: a Double Blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03794427
- Acronym / sponsor ID
- 181218
- Conditions
- Cognitive Decline
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Makassed General HospitalUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 7 Jan 2019 (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 fracture is a potentially devastating event, and serious surgical and medical complications occur frequently especially for elderly patients. Delirium is one of the common complications after hip surgery. Controversy exists regarding the possible impact of type of anesthesia (nerve block versus spinal) upon acute and long-term cognitive decline.
The primary objective is to assess the association between type of anesthesia (nerve block vs. spinal anesthesia) and risk of cognitive decline (CD). The secondary objective is to compare intra-operative hemodynamic changes, use of vasopressor drugs, and use of post-operative analgesics with respect to the type of anesthesia.
Prospective, double blind randomized clinical trial of hip fracture patients who will be assessed for CD pre- and postoperatively, using the Mini Mental State Examination (MMSE). The presence of CD will be determined at follow-up evaluation up to three months after surgery.
Detailed description
Prospective, double blind randomized clinical trial of hip fracture patients who will be assessed for CD pre- and postoperatively, using the Mini Mental State Examination (MMSE). The presence of CD will be determined at follow-up evaluation up to three months after surgery. Patients undergoing hip surgery will be randomized into two groups. Group 1 will receive unilateral lumbosacral nerve block (sciatic nerve block and paravertebral block at levels L3-L4 and L4-L5) as well as placebo injection (1 ml normal saline) at the spinal anesthesia level (L3-L4 or L4-L5). The sciatic nerve will be injected by 20 ml of the anesthetic mixture whereas levels L3-L4 and L4-L5 will be injected by a total of 20 ml of the anesthetic mixture without exceeding the maximum injected volume of 1 ml/kg. Group 2 will receive spinal anesthesia (3 ml of 0.5% bupivacaine) in addition to placebo injection at the sciatic, L3-L4 and L4-L5 levels.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| unilateral lumbosacral nerve block | Experimental | Other: unilateral lumbosacral nerve block, Other: Placebo at the spinal anesthesia levelSciatic nerve block and paravertebral block at levels L3-L4 and L4-L5 will be performed |
| Spinal anesthesia | Active comparator | Other: Spinal anesthesia, Other: Placebo at lumbosacral levelspinal anesthesia will be performed |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Admitted with a hip fracture (femoral neck, trochanteric or sub-trochanteric)
- 40 kg in weight and higher
Key exclusion criteria (7 listed)
- Uncooperative
- Considered as moribund by the orthopedic surgeon at admission
- Alzheimer
- Severe cognitive impairment (MMSE<18)
- Absolute contraindication for spinal anesthesia (assessed preoperatively)
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 |
|---|---|---|
| unilateral lumbosacral nerve blockPatients will receive unilateral lumbosacral nerve block (sciatic nerve block and paravertebral block at levels L3-L4 and L4-L5). The sciatic nerve will be injected by 20 ml of the anesthetic mixture whereas levels L3-L4 and L4-L5 will be injected by a total of 20 ml of the anesthetic mixture without exceeding the maximum injected volume of 1 ml/kg. | Other | unilateral lumbosacral nerve block |
| Spinal anesthesiaPatients will receive spinal anesthesia (3 ml of 0.5% bupivacaine) | Other | Spinal anesthesia |
| Placebo at the spinal anesthesia levelPatients will receive 1 ml normal saline at the spinal anesthesia level (L3-L4 or L4-L5). | Other | unilateral lumbosacral nerve block |
| Placebo at lumbosacral levelPatients will receive normal saline at the sciatic, L3-L4 and L4-L5 levels | Other | Spinal anesthesia |
Primary outcome
Cognitive decline
Time frame: before operation (baseline)
Patients' cognitive function will be assessed using the Mini Mental State Examination. The total score ranges between 0 and 30. A total score between 24 and 30 indicates no cognitive impairment. A score between 18 and 23 indicates mild cognitive impairment. A score between 0 and 17 indicates severe cognitive impairment
Cognitive decline
Time frame: 1 day after the operation
Patients' cognitive function will be assessed using the Mini Mental State Examination. The total score ranges between 0 and 30. A total score between 24 and 30 indicates no cognitive impairment. A score between 18 and 23 indicates mild cognitive impairment. A score between 0 and 17 indicates severe cognitive impairment
Cognitive decline
Time frame: 7 days after the operation
Patients' cognitive function will be assessed using the Mini Mental State Examination. The total score ranges between 0 and 30. A total score between 24 and 30 indicates no cognitive impairment. A score between 18 and 23 indicates mild cognitive impairment. A score between 0 and 17 indicates severe cognitive impairment
Cognitive decline
Time frame: 1 month after the operation
Patients' cognitive function will be assessed using the Mini Mental State Examination. The total score ranges between 0 and 30. A total score between 24 and 30 indicates no cognitive impairment. A score between 18 and 23 indicates mild cognitive impairment. A score between 0 and 17 indicates severe cognitive impairment
Cognitive decline
Time frame: 2 months after the operation
Patients' cognitive function will be assessed using the Mini Mental State Examination. The total score ranges between 0 and 30. A total score between 24 and 30 indicates no cognitive impairment. A score between 18 and 23 indicates mild cognitive impairment. A score between 0 and 17 indicates severe cognitive impairment
Cognitive decline
Time frame: 3 months after operation
Patients' cognitive function will be assessed using the Mini Mental State Examination. The total score ranges between 0 and 30. A total score between 24 and 30 indicates no cognitive impairment. A score between 18 and 23 indicates mild cognitive impairment. A score between 0 and 17 indicates severe cognitive impairment
3 secondary outcomes
Intra-operative hemodynamic changes
Time frame: 1 minute intra-operative
Intra-operative hemodynamic changes
Time frame: 5 minutes intra-operative
Intra-operative hemodynamic changes
Time frame: every 10 minutes intra-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
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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.
Zoher Naja principal investigator
Makassed General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing unilateral lumbosacral nerve block and Spinal anesthesia in people with Cognitive Decline, run by Makassed General Hospital at 1 site in Lebanon.
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 2 inclusion and 7 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 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Zoher Naja (+9611636000 ext. 6405, zouhnaja@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive decline (time frame: before operation (baseline)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jan 2022.