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

NCT02848599 | Completed Phase 2 Results

• 1 other identifier: 25-1:6563-3/2014
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Cognitive Dysfunction

Keywords

postoperative analgesia; postoperative cognitive disfunction

Outcome Measures

Primary Outcomes (2)

• Interleukin-6 Concentration in Peripheral Blood.

  Measurement will be done before and 24 and 72 hours after the surgery.

  Before, 24 and 72 hours after the surgery

• Changes in Cognitive Function

  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. Mini-Mental State Examination Scale: minimum score is 0 and maximum score is 30; the severity of cognitive impairment: no cognitive impairment=25-30; mild cognitive impairment=19-24; moderate cognitive impairment=10-18; and severe cognitive impairment\<9. Higher scores mean a better and lower scores mean a worse outcome.

  Before, 24,48,72,96 and 120 hours after the surgery

Secondary Outcomes (4)

• Changes in C-reactive Protein (CRP) Levels

  Before, 24,72 and 120 hours after the surgery

• Changes in Fibrinogen Concentrations in Peripheral Blood

  Before, 24,72 and 120 hours after the surgery

• Changes in Pain Intensity

  During the first 72 hours after the surgery assessment will be done every 3 hours, after that assessment will be done 3 times daily until discharge

• Postoperative Hospital Stay

  14 days

Study Arms (2)

morphine

ACTIVE COMPARATOR

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

levobupivacaine

ACTIVE COMPARATOR

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

Interventions

morphine DRUG

morphine

levobupivacaine DRUG

Also known as: Chirocaine

levobupivacaine

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Osijek University Hospital: lead

Study Sites (1)

Clinical Hospital Centre Osijek

Osijek, 31000, Croatia

Location

Related Publications (24)

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• Kristek G, Rados I, Kristek D, Kapural L, Neskovic N, Skiljic S, Horvat V, Mandic S, Harsanji-Drenjancevic I. Influence of postoperative analgesia on systemic inflammatory response and postoperative cognitive dysfunction after femoral fractures surgery: a randomized controlled trial. Reg Anesth Pain Med. 2019 Jan;44(1):59-68. doi: 10.1136/rapm-2018-000023.

  PMID: 30640654 DERIVED

MeSH Terms

Conditions

Postoperative Cognitive Complications

Interventions

Morphine; Levobupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Gordana Kristek
• Organization: University Hospital Osijek, Croatia

gordanaldrmed@yahoo.com

+385915115746

Study Officials

• Gordana Kristek, MD

  Clinical Hospital Centre Osijek

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2016
• First Posted: July 28, 2016
• Study Start: July 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: September 1, 2017
• Last Updated: September 1, 2020
• Results First Posted: September 1, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)