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

Cognitive Decline Clinical Trial

Official title:

Cognitive Changes After Hip Prosthesis; Comparison Between Combined Lumbosacral Nerve Block Versus Spinal Anesthesia: a Double Blind Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03794427
• Other study ID #: 181218
• Status: Recruiting
• Phase: N/A
• Start date: January 2, 2019
• Est. completion date: April 2022

Study information

• Verified date: January 2022
• Source: Makassed General Hospital
• Contact: Zoher Naja
• Phone: +9611636000
• Email: zouhnaja[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Decline
• Cognitive Dysfunction

Intervention

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.
• Spinal anesthesia
Patients will receive spinal anesthesia (3 ml of 0.5% bupivacaine)
• Placebo at the spinal anesthesia level
Patients will receive 1 ml normal saline at the spinal anesthesia level (L3-L4 or L4-L5).
• Placebo at lumbosacral level
Patients will receive normal saline at the sciatic, L3-L4 and L4-L5 levels

Locations

Country	Name	City	State
Lebanon	Makassed General Hospital	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
Makassed General Hospital

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Intra-operative hemodynamic changes	Mean arterial pressure (in mmHg) will be recorded through a questionnaire	1 minute intra-operative
Secondary	Intra-operative hemodynamic changes	Mean arterial pressure (in mmHg) will be recorded through a questionnaire	5 minutes intra-operative
Secondary	Intra-operative hemodynamic changes	Mean arterial pressure (in mmHg) will be recorded through a questionnaire	every 10 minutes intra-operative