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The Influence of Postoperative Analgesia on Systemic Inflammatory Response and POCD After Femoral Fractures Surgery

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ClinicalTrials.gov Identifier: NCT02848599
Recruitment Status : Unknown
Verified May 2017 by Osijek University Hospital.
Recruitment status was:  Recruiting
First Posted : July 28, 2016
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Osijek University Hospital

Brief Summary:
The purpose of this study is to determine whether epidural levobupivacaine applied for the purpose of post-operative analgesia compared to systemic analgesia with morphine leads to better pain control, stronger suppression of the inflammatory response and the production of inflammatory mediators, faster recovery of patients and consequently less incidence of postoperative cognitive dysfunction (POCD) in elderly patients after surgical treatment of femoral fractures.

Condition or disease Intervention/treatment Phase
Postoperative Cognitive Dysfunction Drug: morphine Drug: levobupivacaine Phase 2

Detailed Description:
The research will be carried out at the Department of Surgery at Clinical Hospital Centre(CHC) Osijek after approval by the Ethics Committee of CHC Osijek and will be organized as a prospective randomized trial. Respecting the including and excluding criteria for participation in the study, the research will include 70 patients aged 65 years and over who are undergoing surgery for proximal femur fractures and will be operated with the same operating technique (osteosynthesis with nail). All participants will receive the same type of anesthesia and one of two forms of post-operative analgesia, so it will be divided into two groups (35 patients) depending on which form of post-operative analgesia receive. Randomization will be performed by drawing an envelope in which the specified one or other form of post-operative analgesia will be written. The study will be stopped in case of serious complications life-threatening (excessive sedation, respiratory insufficiency, hemodynamic instability and profound hypotension, heart rhythm disorders), which could possibly be related to the administration of drugs used for postoperative analgesia.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Influence of Postoperative Analgesia on Systemic Inflammatory Response and Postoperative Cognitive Disfunction in Elderly Patients After Surgical Repair of Femoral Fractures
Study Start Date : July 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: morphine
The patient-controlled intravenous analgesia with morphine (basal flow of 0.5-2 mg / h, bolus dose of 0.5 mg, lockout interval of 20 minutes, hour limit of 3 doses), which will be carried out 72 hours after the surgery
Drug: morphine
Active Comparator: levobupivacaine
Upon completion of the operation for a period of 72 hours will be implemented continuous epidural local anesthetic through the Patient Controlled Analgesia (PCA) pump (Levobupivacaine 0.125%, basal flow of 6 ml / hour, a bolus dose of 2 ml, lockout interval of 20 minutes, hour limit of 3 doses).
Drug: levobupivacaine
Other Name: Chirocaine




Primary Outcome Measures :
  1. Changes in interleukin-6 concentration in peripheral blood. [ Time Frame: within first 120 hours after the surgery ]
    Measurement will be done before and 24 and 72 hours after the surgery.

  2. Changes in Cognitive Function [ Time Frame: within first 120 hours after the surgery ]
    Assessment of cognitive function will be done using the Mini-mental state examination (MMSE) rating scales before and 24,48,72,96 and 120 hours after the surgery at the same time every morning.


Secondary Outcome Measures :
  1. Changes in C-reactive protein (CRP) levels [ Time Frame: within first 120 hours after the surgery ]
    Measurement will be done before and 24,72 and 120 hours after the surgery.

  2. Complete and differential blood count [ Time Frame: within first 120 hours after the surgery ]
    Measurement will be done before and 24,72 and 120 hours after the surgery.

  3. Changes in fibrinogen concentrations in peripheral blood [ Time Frame: within first 120 hours after the surgery ]
    Measurement will be done before and 24,72 and 120 hours after the surgery.

  4. Changes in blood glucose levels [ Time Frame: within first 120 hours after the surgery ]
    Measurement will be done before and 24,72 and 120 hours after the surgery.

  5. Changes in anxiety and depression [ Time Frame: within first 120 hours after the surgery ]
    Assessment of anxiety and depression will be done using the Hospital rating scales before and 24 and 120 hours after the surgery at the same time in the morning.

  6. Changes in pain intensity [ Time Frame: within first 120 hours after the surgery ]
    Assessment will be done using Numeric Rating Scale (NRS). During the first 72 hours after the surgery assessment will be done every 3 hours, after that assessment will be done 3 times daily

  7. Changes in Systolic Blood Pressure [ Time Frame: within first 120 hours after the surgery ]
    non-invasive measurement, during the first 72 hours after the surgery assessment will be done every 3 hours, after that assessment will be done 3 times daily

  8. Changes in heart rate [ Time Frame: within first 120 hours after the surgery ]
    During the first 72 hours after the surgery assessment will be done every 3 hours, after that assessment will be done 3 times daily

  9. Changes in respiratory rate [ Time Frame: within first 120 hours after the surgery ]
    During the first 72 hours after the surgery assessment will be done every 3 hours, after that assessment will be done 3 times daily

  10. Changes in body temperature [ Time Frame: within first 120 hours after the surgery ]
    During the first 72 hours after the surgery assessment will be done every 3 hours, after that assessment will be done 3 times daily



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patients age 65 and over
  • fracture of the proximal femur
  • preoperative assessment American Society of Anesthesiologists(ASA) score I - ASA III
  • a written consent of the patient to participate in research

Exclusion Criteria:

  • patient non-compliance
  • ASA status IV and IV above
  • patients younger than 65 years
  • dementia, Parkinson's disease, cerebrovascular accident history; simultaneous head injuries,the use of opioids and benzodiazepines longer than a month before the surgery; alcoholism; serious liver disease (class C according to Child-Pugh's classification); severe kidney disease that require dialysis
  • result of MMSE test (Mini-Mental State Examination) under 17
  • the existence of any contraindications for the implementation of regional anesthesia and one or other form of post-operative analgesia.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02848599


Contacts
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Contact: Gordana Kristek, MD +385915115746 gordanaldrmed@yahoo.com
Contact: Dalibor Kristek, MD +385915102219 kristekd@yahoo.com

Locations
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Croatia
Clinical Hospital Centre Osijek Recruiting
Osijek, Croatia, 31000
Contact: Gordana Kristek, MD    +385915115746    gordanaldrmed@yahoo.com   
Sub-Investigator: Sonja Škiljić, MD         
Sub-Investigator: Nenad Nešković, MD         
Sponsors and Collaborators
Osijek University Hospital
Investigators
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Principal Investigator: Gordana Kristek, MD Clinical Hospital Centre Osijek

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Osijek University Hospital
ClinicalTrials.gov Identifier: NCT02848599     History of Changes
Other Study ID Numbers: 25-1:6563-3/2014
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Osijek University Hospital:
postoperative analgesia
postoperative cognitive disfunction
Additional relevant MeSH terms:
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Femoral Fractures
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Fractures, Bone
Wounds and Injuries
Leg Injuries
Morphine
Levobupivacaine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Local
Anesthetics