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

Primary Purpose

Cognitive Decline

Status
Recruiting
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
unilateral lumbosacral nerve block
Spinal anesthesia
Placebo at the spinal anesthesia level
Placebo at lumbosacral level
Sponsored by
Makassed General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cognitive Decline

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Makassed General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

unilateral lumbosacral nerve block

Spinal anesthesia

Arm Description

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

spinal anesthesia will be performed

Outcomes

Primary Outcome Measures

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
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
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
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
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
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

Secondary Outcome Measures

Intra-operative hemodynamic changes
Mean arterial pressure (in mmHg) will be recorded through a questionnaire
Intra-operative hemodynamic changes
Mean arterial pressure (in mmHg) will be recorded through a questionnaire
Intra-operative hemodynamic changes
Mean arterial pressure (in mmHg) will be recorded through a questionnaire

Full Information

First Posted
December 25, 2018
Last Updated
January 14, 2022
Sponsor
Makassed General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03794427
Brief Title
Combined Lumbosacral Nerve Block Versus Spinal Anesthesia for Cognitive Function After Hip Prothesis
Official Title
Cognitive Changes After Hip Prosthesis; Comparison Between Combined Lumbosacral Nerve Block Versus Spinal Anesthesia: a Double Blind Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 2, 2019 (Actual)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
April 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Makassed General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Decline

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
unilateral lumbosacral nerve block
Arm Type
Experimental
Arm Description
Sciatic nerve block and paravertebral block at levels L3-L4 and L4-L5 will be performed
Arm Title
Spinal anesthesia
Arm Type
Active Comparator
Arm Description
spinal anesthesia will be performed
Intervention Type
Other
Intervention Name(s)
unilateral lumbosacral nerve block
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Spinal anesthesia
Intervention Description
Patients will receive spinal anesthesia (3 ml of 0.5% bupivacaine)
Intervention Type
Other
Intervention Name(s)
Placebo at the spinal anesthesia level
Intervention Description
Patients will receive 1 ml normal saline at the spinal anesthesia level (L3-L4 or L4-L5).
Intervention Type
Other
Intervention Name(s)
Placebo at lumbosacral level
Intervention Description
Patients will receive normal saline at the sciatic, L3-L4 and L4-L5 levels
Primary Outcome Measure Information:
Title
Cognitive decline
Description
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
Time Frame
before operation (baseline)
Title
Cognitive decline
Description
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
Time Frame
1 day after the operation
Title
Cognitive decline
Description
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
Time Frame
7 days after the operation
Title
Cognitive decline
Description
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
Time Frame
1 month after the operation
Title
Cognitive decline
Description
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
Time Frame
2 months after the operation
Title
Cognitive decline
Description
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
Time Frame
3 months after operation
Secondary Outcome Measure Information:
Title
Intra-operative hemodynamic changes
Description
Mean arterial pressure (in mmHg) will be recorded through a questionnaire
Time Frame
1 minute intra-operative
Title
Intra-operative hemodynamic changes
Description
Mean arterial pressure (in mmHg) will be recorded through a questionnaire
Time Frame
5 minutes intra-operative
Title
Intra-operative hemodynamic changes
Description
Mean arterial pressure (in mmHg) will be recorded through a questionnaire
Time Frame
every 10 minutes intra-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zoher Naja
Phone
+9611636000
Ext
6405
Email
zouhnaja@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zoher Naja
Organizational Affiliation
Makassed General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Makassed General Hospital
City
Beirut
Country
Lebanon
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zoher Naja, MD
Phone
+9611636000
Ext
6941
Email
zouhnaja@yahoo.com

12. IPD Sharing Statement

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

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