Combined Lumbosacral Nerve Block Versus Spinal Anesthesia for Cognitive Function After Hip Prothesis

Study Overview
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Brief Summary
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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. Controversy exists regarding the possible impact of type of anesthesia (nerve block versus spinal) upon acute and long-term cognitive decline. The primary objective is to assess the association between type of anesthesia (nerve block vs. spinal anesthesia) and risk of cognitive decline (CD). The secondary objective is to compare intra-operative hemodynamic changes, use of vasopressor drugs, and use of post-operative analgesics with respect to the type of anesthesia. Prospective, double blind randomized clinical trial of hip fracture patients who will be assessed for CD pre- and postoperatively, using the Mini Mental State Examination (MMSE). The presence of CD will be determined at follow-up evaluation up to three months after surgery.

Detailed Description
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Prospective, double blind randomized clinical trial of hip fracture patients who will be assessed for CD pre- and postoperatively, using the Mini Mental State Examination (MMSE). The presence of CD will be determined at follow-up evaluation up to 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). The sciatic nerve will be injected by 20 ml of the anesthetic mixture whereas levels L3-L4 and L4-L5 will be injected by a total of 20 ml of the anesthetic mixture without exceeding the maximum injected volume of 1 ml/kg. Group 2 will receive spinal anesthesia (3 ml of 0.5% bupivacaine) in addition to placebo injection at the sciatic, L3-L4 and L4-L5 levels.

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

Conditions
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Cognitive Decline

Intervention / Treatment
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* Other: unilateral lumbosacral nerve block
* Other: Spinal anesthesia
* Other: Placebo at the spinal anesthesia level
* Other: Placebo at lumbosacral level


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Admitted with a hip fracture (femoral neck, trochanteric or sub-trochanteric) 40 kg in weight and higher Exclusion Criteria: Patients who are: 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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: unilateral lumbosacral nerve block<br>Sciatic nerve block and paravertebral block at levels L3-L4 and L4-L5 will be performed | Other: unilateral lumbosacral nerve block<br>* Patients will receive unilateral lumbosacral nerve block (sciatic nerve block and paravertebral block at levels L3-L4 and L4-L5). The sciatic nerve will be injected by 20 ml of the anesthetic mixture whereas levels L3-L4 and L4-L5 will be injected by a total of 20 ml of the anesthetic mixture without exceeding the maximum injected volume of 1 ml/kg.<br>Other: Placebo at the spinal anesthesia level<br>* Patients will receive 1 ml normal saline at the spinal anesthesia level (L3-L4 or L4-L5).<br>|
| Active Comparator: Spinal anesthesia<br>spinal anesthesia will be performed | Other: Spinal anesthesia<br>* Patients will receive spinal anesthesia (3 ml of 0.5% bupivacaine)<br>Other: Placebo at lumbosacral level<br>* Patients will receive normal saline at the sciatic, L3-L4 and L4-L5 levels<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive decline | Patients' cognitive function will be assessed using the Mini Mental State Examination. The total score ranges between 0 and 30. A total score between 24 and 30 indicates no cognitive impairment. A score between 18 and 23 indicates mild cognitive impairment. A score between 0 and 17 indicates severe cognitive impairment | before operation (baseline) | 
| Cognitive decline | Patients' cognitive function will be assessed using the Mini Mental State Examination. The total score ranges between 0 and 30. A total score between 24 and 30 indicates no cognitive impairment. A score between 18 and 23 indicates mild cognitive impairment. A score between 0 and 17 indicates severe cognitive impairment | 1 day after the operation | 
| Cognitive decline | Patients' cognitive function will be assessed using the Mini Mental State Examination. The total score ranges between 0 and 30. A total score between 24 and 30 indicates no cognitive impairment. A score between 18 and 23 indicates mild cognitive impairment. A score between 0 and 17 indicates severe cognitive impairment | 7 days after the operation | 
| Cognitive decline | Patients' cognitive function will be assessed using the Mini Mental State Examination. The total score ranges between 0 and 30. A total score between 24 and 30 indicates no cognitive impairment. A score between 18 and 23 indicates mild cognitive impairment. A score between 0 and 17 indicates severe cognitive impairment | 1 month after the operation | 
| Cognitive decline | Patients' cognitive function will be assessed using the Mini Mental State Examination. The total score ranges between 0 and 30. A total score between 24 and 30 indicates no cognitive impairment. A score between 18 and 23 indicates mild cognitive impairment. A score between 0 and 17 indicates severe cognitive impairment | 2 months after the operation | 
| Cognitive decline | Patients' cognitive function will be assessed using the Mini Mental State Examination. The total score ranges between 0 and 30. A total score between 24 and 30 indicates no cognitive impairment. A score between 18 and 23 indicates mild cognitive impairment. A score between 0 and 17 indicates severe cognitive impairment | 3 months after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-operative hemodynamic changes | Mean arterial pressure (in mmHg) will be recorded through a questionnaire | 1 minute intra-operative | 
| Intra-operative hemodynamic changes | Mean arterial pressure (in mmHg) will be recorded through a questionnaire | 5 minutes intra-operative | 
| Intra-operative hemodynamic changes | Mean arterial pressure (in mmHg) will be recorded through a questionnaire | every 10 minutes intra-operative |