Spinal Anesthesia Vs. Neve Block in Risk of Cognitive Decline

NCT06963229 | Active Not Recruiting DMC

• 1 other identifier: MGH-07-24002
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Postoperative Cognitive Complications

Keywords

Fractures, Hip; Nerve Block; Spinal Anesthesia; Nerve, Sciatic; paravertebral; Aged

Outcome Measures

Primary Outcomes (1)

• Assessment of Cognitive Decline Post-operatively

  A questionnaire will be used to collect data. Demographic information including age (by year), gender, ASA score (I-IV), BMI (kg/m\^2), clinical condition pre-fracture (MMSE Score), as well as type and duration (by days) of fracture will be collected. The patient's cognitive function will be assessed before the operation using the MMSE. The MMSE is a validated questionnaire that is comprised of six sections examining the following functions: orientation, registration, attention and calculation, recall, language, as well as ability to follow simple commands and orientation. Illiterate patients will not be asked the questions pertaining to attention and calculation in addition to language questions. Hence, for these patients the score will be over 23 but it will be converted to a score over 30. Total Score is 30; a score between 24 and 30 indicates no cognitive impairment, a score between 18 and 23 means mild cognitive impairment and a score between 0 and17 indicates severe impairment

  3 Months

Study Arms (2)

Spinal Anesthesia

ACTIVE COMPARATOR

Procedure: Spinal Anesthesia (bupivacaine)

Lumbosacral Nerve Block

ACTIVE COMPARATOR

Procedure: Peripheral Nerve Block

Interventions

Spinal Anesthesia (bupivacaine) PROCEDURE

L3-L4 or L4-L5 3cc of 2% bupivacaine

Spinal Anesthesia

Peripheral Nerve Block PROCEDURE

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%

Lumbosacral Nerve Block

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Admitted with a hip fracture (femoral neck, trochanteric or sub-trochanteric)
• years or older
• Kgs in weight and higher

You may not qualify if:

• 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
• Have any severe visual disorder or debilitating vascular event

Sponsors & Collaborators

• Makassed General Hospital: lead

Study Sites (1)

Makassed General Hospital

Beirut, Lebanon, 00000, Lebanon

Location

Related Publications (8)

• 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.

  PMID: 11126507 BACKGROUND

• 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.

  PMID: 24186470 BACKGROUND

• 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.

  PMID: 25144505 BACKGROUND

• 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.

  PMID: 30526923 BACKGROUND

• 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.

  PMID: 22762316 BACKGROUND

• 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.

  PMID: 20664045 BACKGROUND

• 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.

  PMID: 18577850 BACKGROUND

• 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.

  PMID: 19421703 BACKGROUND

Related Links

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MeSH Terms

Conditions

Postoperative Cognitive Complications; Hip Fractures

Interventions

Anesthesia, Spinal; Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of Anesthesia Department

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: May 8, 2025
• Study Start: April 21, 2025
• Primary Completion: February 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 14, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)