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NCT Number: NCT06963229

Spinal Anesthesia Vs. Neve Block in Risk of Cognitive Decline

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Makassed General Hospital

Beirut, Lebanon, 00000

About this study

Hip fracture is a potentially devastating event, and serious surgical and medical complications occur frequently especially for elderly patients. Around one-third of the patients pass away within the first post-operative year.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Admitted with a hip fracture (femoral neck, trochanteric or sub-trochanteric)
  • 65 years or older
  • 40 Kgs 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
  • Have any severe visual disorder or debilitating vascular event

Treatment and study plan

Spinal Anesthesia (bupivacaine)

Procedure

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

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%

Primary outcomes

  1. Assessment of Cognitive Decline Post-operatively

    Time frame: 3 Months

    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

Sponsors and collaborators

Lead sponsor

Makassed General Hospital

Other

Registry information

Official study title

Cognitive Changes After Hip Prosthesis; Comparison Between Combined Lumbosacral Nerve Block Versus Spinal Anesthesia: A Double Blind Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 8, 2025
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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