Phase 2 N=86 Randomized Treatment

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

Postoperative Cognitive Dysfunction

Bottom Line

View on ClinicalTrials.gov: NCT02848599 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2020

Primary outcome: Primary: Interleukin-6 Concentration in Peripheral Blood. — 27.2; 26.6; 104; 97.7 pg/ml

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: morphine (Drug); levobupivacaine (Drug)
Age: Older Adult · 65+ yrs
Sex: All
Sponsor: Osijek University Hospital
Primary completion: Jul 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Interleukin-6 Concentration in Peripheral Blood.	27.2; 26.6; 104; 97.7; 50; 30.5	—
PRIMARY Changes in Cognitive Function	21; 22; 20; 22; 20; 21	—
SECONDARY Changes in C-reactive Protein (CRP) Levels	57.2; 57.8; 106.2; 98.1; 118.5; 95	—
SECONDARY Changes in Fibrinogen Concentrations in Peripheral Blood	5.5; 4.5; 5.3; 4.7; 5.7; 5.2	—
SECONDARY Changes in Pain Intensity	1.4; 0.6; 1.5; 0.5; 1.4; 0.5	—
SECONDARY Postoperative Hospital Stay	7; 7	—

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.

Eligibility 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.

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Data sourced from ClinicalTrials.gov (NCT02848599). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.