Combined Lumbosacral Nerve Block Versus Spinal Anesthesia for Cognitive Function After Hip Prothesis
- Conditions
- Cognitive Decline
- Interventions
- Other: unilateral lumbosacral nerve blockOther: Spinal anesthesiaOther: Placebo at lumbosacral levelOther: Placebo at the spinal anesthesia level
- Registration Number
- NCT03794427
- 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. 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- Admitted with a hip fracture (femoral neck, trochanteric or sub-trochanteric)
- 40 kg in weight and higher
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description unilateral lumbosacral nerve block unilateral lumbosacral nerve block Sciatic nerve block and paravertebral block at levels L3-L4 and L4-L5 will be performed Spinal anesthesia Placebo at lumbosacral level spinal anesthesia will be performed Spinal anesthesia Spinal anesthesia spinal anesthesia will be performed unilateral lumbosacral nerve block Placebo at the spinal anesthesia level Sciatic nerve block and paravertebral block at levels L3-L4 and L4-L5 will be performed
- Primary Outcome Measures
Name Time Method Cognitive decline 3 months after operation 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 Outcome Measures
Name Time Method Intra-operative hemodynamic changes every 10 minutes intra-operative Mean arterial pressure (in mmHg) will be recorded through a questionnaire
Trial Locations
- Locations (1)
Makassed General Hospital
🇱🇧Beirut, Lebanon