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

NCT03794427 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-01-18

No results posted yet for this study

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.

Conditions

Interventions

OTHER

unilateral 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.

OTHER

Spinal anesthesia

Patients will receive spinal anesthesia (3 ml of 0.5% bupivacaine)

OTHER

Placebo at the spinal anesthesia level

Patients will receive 1 ml normal saline at the spinal anesthesia level (L3-L4 or L4-L5).

OTHER

Placebo at lumbosacral level

Patients will receive normal saline at the sciatic, L3-L4 and L4-L5 levels

Sponsors & Collaborators

  • Makassed General Hospital

    lead OTHER

Principal Investigators

  • Zoher Naja · Makassed General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-02
Primary Completion
2022-04-30
Completion
2022-04-30

Countries

  • Lebanon

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03794427 on ClinicalTrials.gov