Spinal Anesthesia Vs. Neve Block in Risk of Cognitive Decline

Not Applicable

Active, not recruiting

• Conditions: Postoperative Cognitive Complications

• Registration Number: NCT06963229
• Lead Sponsor: Makassed General Hospital

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-04
• Study Start: 2025-04-21
• Study First Submitted: 2025-04-21
• Study First Submitted QC: 2025-04-29
• Study First Posted: 2025-05-08
• Last Update Submitted: 2025-05-09
• Last Update Posted: 2025-05-14
• Primary Completion: 2026-02-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Assessment of Cognitive Decline Post-operatively	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

Trial Locations

Locations (1)

Makassed General Hospital; 🇱🇧 Beirut, Lebanon