Cognitive Decline
Conditions
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. 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
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.
Interventions
OTHERunilateral lumbosacral nerve block
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.
OTHERSpinal anesthesia
Patients will receive spinal anesthesia (3 ml of 0.5% bupivacaine)
OTHERPlacebo at the spinal anesthesia level
Patients will receive 1 ml normal saline at the spinal anesthesia level (L3-L4 or L4-L5).
OTHERPlacebo at lumbosacral level
Patients will receive normal saline at the sciatic, L3-L4 and L4-L5 levels
Sponsors
Makassed General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive decline | before operation (baseline) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intra-operative hemodynamic changes | 1 minute intra-operative | Mean arterial pressure (in mmHg) will be recorded through a questionnaire |
Countries
Lebanon
Contacts
Primary ContactZoher Naja
Outcome results
None listed