Combined Lumbosacral Nerve Block Versus Spinal Anesthesia for Cognitive Function After Hip Prothesis
NCT ID: NCT03794427
Last Updated: 2022-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2019-01-02
2022-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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unilateral lumbosacral nerve block
Sciatic nerve block and paravertebral block at levels L3-L4 and L4-L5 will be performed
unilateral lumbosacral nerve block
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.
Placebo at the spinal anesthesia level
Patients will receive 1 ml normal saline at the spinal anesthesia level (L3-L4 or L4-L5).
Spinal anesthesia
spinal anesthesia will be performed
Spinal anesthesia
Patients will receive spinal anesthesia (3 ml of 0.5% bupivacaine)
Placebo at lumbosacral level
Patients will receive normal saline at the sciatic, L3-L4 and L4-L5 levels
Interventions
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unilateral lumbosacral nerve block
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 anesthesia
Patients will receive spinal anesthesia (3 ml of 0.5% bupivacaine)
Placebo at the spinal anesthesia level
Patients will receive 1 ml normal saline at the spinal anesthesia level (L3-L4 or L4-L5).
Placebo at lumbosacral level
Patients will receive normal saline at the sciatic, L3-L4 and L4-L5 levels
Eligibility Criteria
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Inclusion Criteria
* 40 kg in weight and higher
Exclusion Criteria
* 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
65 Years
ALL
No
Sponsors
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Makassed General Hospital
OTHER
Responsible Party
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Zoher Naja
Anesthesiologist
Principal Investigators
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Zoher Naja
Role: PRINCIPAL_INVESTIGATOR
Makassed General Hospital
Locations
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Makassed General Hospital
Beirut, , Lebanon
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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181218
Identifier Type: -
Identifier Source: org_study_id
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