Spinal Anesthesia Vs. Neve Block in Risk of Cognitive Decline
NCT ID: NCT06963229
Last Updated: 2025-05-14
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
50 participants
INTERVENTIONAL
2025-04-21
2026-05-01
Brief Summary
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This study objective is to assess the association between type of anesthesia (nerve block vs. spinal anesthesia) and risk of cognitive decline (CD). And its secondary objective is to compare intra-operative hemodynamic changes, and post-operative pain.
Prospective, double blind randomized clinical trial of hip fracture patients who will be assessed for CD pre- and postoperatively, for 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). Group 2 will receive spinal anesthesia in addition to placebo injection at the sciatic, L3-L4 and L4-L5 levels.
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Detailed Description
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One of the most common complications in hip fracture patients is delirium which is characterized by an acute disturbance in awareness, attention and cognitive function. Delirium has a fluctuating course and is usually reversible. However, evidence suggests an association between delirium and future cognitive decline and development of dementia during months after the delirium episode. Dementia is a chronic syndrome characterized by cognitive decline, impairment in activities of daily living and a change in social abilities and behavior.
Several risk factors are identified for preoperative and postoperative delirium including age, comorbidities, intraoperative hypotension and use of vasopressors. There is some controversy about the cognitive consequences due to the type of anesthesia used.
Spinal and general anesthesia are commonly used for hip surgery. An alternative technique is the combined sciatic-paravertebral block that has been used to overcome the adverse effects associated with spinal and general anesthesia. This anesthetic technique was associated with less intraoperative hypotension and reduced rate of ICU admission. Given the promising effect of paravertebral block on the outcome of hip surgery, we will conduct this study to assess the effect of paravertebral block on postoperative CD.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Spinal Anesthesia
Spinal Anesthesia (bupivacaine)
L3-L4 or L4-L5 3cc of 2% bupivacaine
Lumbosacral Nerve Block
Peripheral Nerve Block
Sciatic Nerve Block 20ml of Anesthetic Mixture, Paravertebral Nerve Block (L3-L4 and L4-L5) 20ml of Anesthetic Mixture
Mixture Details:
* 5ml Lidocaine 2%
* 5ml Lidocaine 1% with Adrenaline (1-200000)
* 10ml Bupivacaine 0.5%
Interventions
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Spinal Anesthesia (bupivacaine)
L3-L4 or L4-L5 3cc of 2% bupivacaine
Peripheral Nerve Block
Sciatic Nerve Block 20ml of Anesthetic Mixture, Paravertebral Nerve Block (L3-L4 and L4-L5) 20ml of Anesthetic Mixture
Mixture Details:
* 5ml Lidocaine 2%
* 5ml Lidocaine 1% with Adrenaline (1-200000)
* 10ml Bupivacaine 0.5%
Eligibility Criteria
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Inclusion Criteria
* 65 years or older
* 40 Kgs in weight and higher
Exclusion Criteria
* 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
* Have any severe visual disorder or debilitating vascular event
65 Years
ALL
No
Sponsors
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Makassed General Hospital
OTHER
Responsible Party
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Omar Rajab
Chairman of Anesthesia Department
Locations
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Makassed General Hospital
Beirut, Lebanon, Lebanon
Countries
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References
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Naja Z, el Hassan MJ, Khatib H, Ziade MF, Lonnqvist PA. Combined sciatic-paravertebral nerve block vs. general anaesthesia for fractured hip of the elderly. Middle East J Anaesthesiol. 2000 Jun;15(5):559-68.
Zywiel MG, Prabhu A, Perruccio AV, Gandhi R. The influence of anesthesia and pain management on cognitive dysfunction after joint arthroplasty: a systematic review. Clin Orthop Relat Res. 2014 May;472(5):1453-66. doi: 10.1007/s11999-013-3363-2.
Davis N, Lee M, Lin AY, Lynch L, Monteleone M, Falzon L, Ispahany N, Lei S. Postoperative cognitive function following general versus regional anesthesia: a systematic review. J Neurosurg Anesthesiol. 2014 Oct;26(4):369-76. doi: 10.1097/ANA.0000000000000120.
Tzimas P, Samara E, Petrou A, Korompilias A, Chalkias A, Papadopoulos G. The influence of anesthetic techniques on postoperative cognitive function in elderly patients undergoing hip fracture surgery: General vs spinal anesthesia. Injury. 2018 Dec;49(12):2221-2226. doi: 10.1016/j.injury.2018.09.023. Epub 2018 Sep 11.
Saczynski JS, Marcantonio ER, Quach L, Fong TG, Gross A, Inouye SK, Jones RN. Cognitive trajectories after postoperative delirium. N Engl J Med. 2012 Jul 5;367(1):30-9. doi: 10.1056/NEJMoa1112923.
Witlox J, Eurelings LS, de Jonghe JF, Kalisvaart KJ, Eikelenboom P, van Gool WA. Delirium in elderly patients and the risk of postdischarge mortality, institutionalization, and dementia: a meta-analysis. JAMA. 2010 Jul 28;304(4):443-51. doi: 10.1001/jama.2010.1013.
Bickel H, Gradinger R, Kochs E, Forstl H. High risk of cognitive and functional decline after postoperative delirium. A three-year prospective study. Dement Geriatr Cogn Disord. 2008;26(1):26-31. doi: 10.1159/000140804. Epub 2008 Jun 24.
Abrahamsen B, van Staa T, Ariely R, Olson M, Cooper C. Excess mortality following hip fracture: a systematic epidemiological review. Osteoporos Int. 2009 Oct;20(10):1633-50. doi: 10.1007/s00198-009-0920-3. Epub 2009 May 7.
Related Links
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Related Info
Other Identifiers
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MGH-07-24002
Identifier Type: -
Identifier Source: org_study_id
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