Clinical trial NCT06963229: Spinal Anesthesia Vs. Neve Block in Risk of Cognitive Decline
Official title: Cognitive Changes After Hip Prosthesis; Comparison Between Combined Lumbosacral Nerve Block Versus Spinal Anesthesia: A Double Blind Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Postoperative Cognitive Complications
Keywords: Fractures, Hip
Nerve Block
Spinal Anesthesia
Nerve, Sciatic
paravertebral
Aged
Lead sponsor: Makassed General Hospital
Sponsor class: OTHER
First posted: 2025-05-08
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of Cognitive Decline Post-operatively
timeFrame: 3 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Makassed General Hospital
Study officials:
References:
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citation: 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.