Influence of Intrathecal Dexamethasone Administration for Proximal Femoral Fractures

General Hospital Sveti Duh

Status: Completed

Conditions: Cognition Disorders; Cortisol; Hypersecretion; Femoral Fracture

Treatments: Drug: 8 mg of dexamethasone; Drug: 12,5 mg of 0,5 % of levobupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03856502

662809198348

Details and patient eligibility

About

Spinal anesthesia blocks acute pain in older patients with femur fracture. Delirium is a common complication seen after femur fracture, affecting approximately 10-16% of patients. It is associated with increased mortality at 1st year, delayed rehabilitation efforts, prolonged length of hospital stay, poorer functional outcomes, and increased risk of nursing home placement.

Intrathecal dexamethasone administration improves quality of anesthesia in patients with femur fracture compared to conventional spinal anesthesia.

Full description

The aim of this research was to establish the influence of intrathecal dexamethasone administration in spinal anaesthesia with levobupivacaine on postoperative pain and changes of consciousness, values of cortisol levels and quality of treatment for patients with femoral fractures compared to spinal anaesthesia with only local anaesthetic.

The study was planned as a prospective, observational, randomised clinical trial. A total of 60 patients ASA2 and ASA3 status, scheduled for surgical procedures were sorted into two groups and underwent surgery in spinal anesthesia with levobupivacaine with or without dexamethsone.

Enrollment: 60 patients

Sex: All

Ages: 50 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• cooperative ASA 2 and ASA 3 status patients with proximal femoral fractures of one leg
• agreed to be enrolled in the study (Informed Consent signed)

Exclusion criteria

• patients refused to be enrolled in the study
• patients with pre-existing cognitive disturbances before surgery
• conditions or diseases with corticosteroid therapy, long term corticosteroid, diabetes mellitus, neurological conditions or tumors, neuroendocrine disorders or tumors
• breaking the study protocols
• patients who no longer wanted to be enrolled in the study
• unexpected events when the study already started

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

group that received dexamethasone (DLSA)

Experimental group

Description:

The study group of 30 patients ASA status 2 or 3 received 8 mg of dexamethasone with 12,5 mg of 0,5% of levobupivacaine intrathecally for surgical reconstruction of proximal femoral fracture. Spinal anaesthesia was performed in sitting position using middle approach in intervertebral space L2-L3 or L3-L4 with spinal needles 22-27 GA.

Treatment:

Drug: 12,5 mg of 0,5 % of levobupivacaine

Drug: 8 mg of dexamethasone

group without dexamethasone (LSA)

Active Comparator group

Description:

The control group of 30 patients ASA status 2 or 3 received 12,5 mg of 0,5% of levobupivacaine intrathecally for surgical reconstruction of proximal femoral fracture. Spinal anaesthesia was performed in sitting position using middle approach in intervertebral space L2-L3 or L3-L4 with spinal needles 22-27 GA.

Treatment:

Drug: 12,5 mg of 0,5 % of levobupivacaine