Influence of Intrathecal Dexamethasone Administration for Proximal Femoral Fractures

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Impact of Intrathecal Dexamethasone Administration for Elderly Patients With Proximal Femoral Fracture

Conditions
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Femoral Fracture, Cognition Disorders, Cortisol; Hypersecretion

Intervention / Treatment
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* Drug: 8 mg of dexamethasone
* Drug: 12,5 mg of 0,5 % of levobupivacaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group that received dexamethasone (DLSA)<br>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. | Drug: 8 mg of dexamethasone<br>* Effect of intrathecally administered dexamethasone in spinal anaesthesia for surgical correction of the hip fracture.<br>* Other names: Dexamethasone KRKA, Chirocaine Abbott;Drug: 12,5 mg of 0,5 % of levobupivacaine<br>* Local anaesthetic standardly used in spinal anaesthesia for surgical correction of the hip fracture by the particular hospital's protocol.<br>* Other names: Chirocaine Abbott;|
| Active Comparator: group without dexamethasone (LSA)<br>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. | Drug: 12,5 mg of 0,5 % of levobupivacaine<br>* Local anaesthetic standardly used in spinal anaesthesia for surgical correction of the hip fracture by the particular hospital's protocol.<br>* Other names: Chirocaine Abbott;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative cognitive change | Assessed using a simplified Confusion Assessment Method scoring scale, a clinical instrument for delirium assessment used by non-psychiatric medical staff after surgery for excluding delirium. Delirium is defined in terms of 4 possible diagnostic criteria (1. acute onset or fluctuating course; 2- inattention; 3- disorganised thinking; 4- altered level of consciousness (may be defined as alert, lethargic, stupor or coma cognitive state)) and is defined as present when 1 plus 2 and either 3 or 4 diagnostic criteria are positive. | Confusion Assessment Method scoring was assessed in 4 measure points: 1. one hour after surgery, 2. on the 3rd postoperative day at 9 am, 3. on the 5th postoperative day at 9 am, 4. on the 10th postoperative day at 9 am | 
| cortisol concentrations changes | Determined from patient's blood plasma assessed by Roche Elecsys Immunoassay System and defined from the laboratory reference points (185-624)nmol/L equal for each measure point; for single measuring 0,5 ml of patient's blood was taken | Measured in 5 measure points: 1. one hour before surgery, 2. one hour after surgery, 3. on the 3rd postoperative day at 6 am, 4. on the 5th postoperative day at 6 am, 5. on the 10th postoperative day at 6 am | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| perioperative pain intensity: Visual Analogue Scale score | Assessed using Visual Analogue Scale score and establishing postoperative analgesic requirements | Visual Analogue Scale scoring (scores: 0-10) was assessed in 5 measure points every 3 hours when patient was awake: 1. 1 h before surgery, 2. 1 h after surgery, 3. on the 3rd postoperative day, 4. on the 5th postoperative day, 5. 10th postoperative day | 
| glucose concentrations changes | Determined form patient's blood plasma assessed by Beckman Coulter AU400 and AU680 orbOlympus Glucose Analyzer 2 devices defined from the laboratory reference points (4,4-6,4)mmol/L equal for each measure point; for single measuring 0,2 ml of patient's blood was taken | Measured in 5 measure points (units: mmol/L): 1. one hour before surgery, 2. one hour after surgery, 3. on the 3rd postoperative day at 6 am, 4. on the 5th postoperative day at 6 am, 5. on the 10th postoperative day at 6 am | 
| Blood loss | Determinated by intraoperative blood loss in mililitres, amount of blood in drainage systems in mililitres, transfusion of homologous blood in mililitres | During the surgical repairment and up to the removal of drainage systems (2nd postoperative day) | 
| Number of Participants with pulmonary embolism | Established by noted pulmonary embolism in the operating room or at the traumatology ward by the ward staff | During surgical reconstruction and during postoperative follow-up of up to ten postoperative days | 
| Number of Participants with heart failure | Established by noted heart failure in the operating room or at the traumatology ward by the ward staff | During surgical reconstruction and during postoperative follow-up of up to ten postoperative days | 
| Platelets changes | Determined from laboratory values of platelets data in reference points (158-424)10^9/L equal for each measure point | Assessed in 5 measure points: 1.one hour before surgery, 2. one hour after surgery, 3. on the 3rd postoperative day at 6 am, 4. on the 5th postoperative day at 6 am, 5. on the 10th postoperative day at 6 am | 
| Haemoglobin changes | Determined from laboratory values of haemoglobin data measured reference points (119-157)g/L equal for each measure point | Assessed in 5 measure points: 1.one hour before surgery, 2. one hour after surgery, 3. on the 3rd postoperative day at 6 am, 4. on the 5th postoperative day at 6 am, 5. on the 10th postoperative day at 6 am | 
| Haematocrit changes | Determined from laboratory values of haematocrit data in reference points (0,356-0,470)L/L equal for each measure point | Assessed in 5 measure points: 1.one hour before surgery, 2. one hour after surgery, 3. on the 3rd postoperative day at 6 am, 4. on the 5th postoperative day at 6 am, 5. on the 10th postoperative day at 6 am | 
| Hospitalisation | Calculated by number of days preoperatively from the day of admission to the day of surgical treatment and postoperatively from the day of surgical treatment to the day of hospital discharge | In the time period of up to 30 days | 
| Number of Participants who underwent surgical procedure during first 48 hours from admission | It was defined if surgical procedure was performed in first 48 hours from admission to the hospital's Emergency Department or later reflecting morbidity and/or mortality | Calculated in hours after the patient's admission to the hospital's Emergency Department to the point of surgical reconstruction in the time period up to 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal anesthesia, femoral fracture, dexamethasone