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

Makassed General Hospital

Status: Unknown

Conditions: Cognitive Decline

Treatments: Other: Spinal anesthesia; Other: Placebo at the spinal anesthesia level; Other: unilateral lumbosacral nerve block; Other: Placebo at lumbosacral level

Study type: Interventional

Funder types: Other

Identifiers

NCT03794427

181218

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

50 participants in 2 patient groups

unilateral lumbosacral nerve block

Experimental group

Description:

Sciatic nerve block and paravertebral block at levels L3-L4 and L4-L5 will be performed

Treatment:

Other: Placebo at the spinal anesthesia level

Other: unilateral lumbosacral nerve block

Spinal anesthesia

Active Comparator group

Description:

spinal anesthesia will be performed

Treatment:

Other: Placebo at lumbosacral level

Other: Spinal anesthesia