Influence of Intrathecal Dexamethasone Administration for Proximal Femoral Fractures

February 26, 2019 updated by: Livija Šakić, MD,PhD, General Hospital Sveti Duh

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Zagreb, Croatia, 10000
        • University Hospital "Sveti Duh"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: group that received dexamethasone (DLSA)
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
Effect of intrathecally administered dexamethasone in spinal anaesthesia for surgical correction of the hip fracture.
Other Names:
  • Dexamethasone KRKA, Chirocaine Abbott
Drug: 12,5 mg of 0,5 % of levobupivacaine
Local anaesthetic standardly used in spinal anaesthesia for surgical correction of the hip fracture by the particular hospital's protocol.
Other Names:
  • Chirocaine Abbott
ACTIVE_COMPARATOR: group without dexamethasone (LSA)
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
Local anaesthetic standardly used in spinal anaesthesia for surgical correction of the hip fracture by the particular hospital's protocol.
Other Names:
  • Chirocaine Abbott

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative cognitive change
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: During the surgical repairment and up to the removal of drainage systems (2nd postoperative day)
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
Time Frame: During surgical reconstruction and during postoperative follow-up of up to ten postoperative days
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
Time Frame: During surgical reconstruction and during postoperative follow-up of up to ten postoperative days
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: In the time period of up to 30 days
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
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

General Hospital Sveti Duh

Investigators

  • Principal Investigator: Livija Šakić, MD,PhD, University Hospital Sveti Duh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 11, 2012

Primary Completion (ACTUAL)

May 26, 2016

Study Completion (ACTUAL)

July 4, 2017

Study Registration Dates

First Submitted

November 2, 2018

First Submitted That Met QC Criteria

February 25, 2019

First Posted (ACTUAL)

February 27, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 28, 2019

Last Update Submitted That Met QC Criteria

February 26, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 662809198348

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The research has been a doctoral thesis.

Study Data/Documents

  1. Individual Participant Data Set
  2. Individual Participant Data Set
  3. Individual Participant Data Set
  4. Individual Participant Data Set
  5. Individual Participant Data Set

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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