NCT03794427

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 25, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

January 2, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 7, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

January 18, 2022

Status Verified

January 1, 2022

Enrollment Period

3.2 years

First QC Date

December 25, 2018

Last Update Submit

January 14, 2022

Conditions

Cognitive Decline

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (3)

  • Intra-operative hemodynamic changes

    1 minute intra-operative

  • Intra-operative hemodynamic changes

    5 minutes intra-operative

  • Intra-operative hemodynamic changes

    every 10 minutes intra-operative

Study Arms (2)

unilateral lumbosacral nerve block

EXPERIMENTAL

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

Other: unilateral lumbosacral nerve blockOther: Placebo at the spinal anesthesia level

Spinal anesthesia

ACTIVE COMPARATOR

spinal anesthesia will be performed

Other: Spinal anesthesiaOther: Placebo at lumbosacral level

Interventions

unilateral lumbosacral nerve blockOTHER

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.

unilateral lumbosacral nerve block
Spinal anesthesiaOTHER

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

Spinal anesthesia
Placebo at the spinal anesthesia levelOTHER

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

unilateral lumbosacral nerve block
Placebo at lumbosacral levelOTHER

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

Spinal anesthesia

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Admitted with a hip fracture (femoral neck, trochanteric or sub-trochanteric)
  • kg in weight and higher

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Makassed General Hospital

Beirut, Lebanon

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Zoher Naja

    Makassed General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zoher Naja

CONTACT

+9611636000zouhnaja@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

December 25, 2018

First Posted

January 7, 2019

Study Start

January 2, 2019

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

January 18, 2022

Record last verified: 2022-01

Locations

LE(1)