Phase 2
Completed N=86
The Influence of Postoperative Analgesia on Systemic Inflammatory Response and POCD After Femoral Fractures Surgery
Source: ClinicalTrials.gov NCT02848599 ↗Enrolled (actual)
86
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcomePrimary: Interleukin-6 Concentration in Peripheral Blood. — 27.2; 26.6; 104; 97.7 pg/ml
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.
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 | — |
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.
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. Informational only — not medical advice.