Anesthesia; Adverse Effect, Spinal and Epidural Clinical Trial
Official title:
Inflammatory Mediators, Neural Tissue Injury Markers and the Markers of Oxidative Stress in the CSF of Patients Undergoing Spinal Anesthesia With Ropivacaine and Bupivacaine
Consenting patients, scheduled for orthopaedic surgery under spinal anesthesia will be
randomly assigned (1:1) to receive ropivacaine or bupivacaine as a single shot before the
start of surgery, followed by bolus doses of the same local anesthetic as required during the
surgery, and continuous infusion of the same local anesthetic for 24 hours postoperatively.
Primary Outcome Measures: Evaluation of changes in concentrations of glutamate in the
cerebrospinal fluid and in the blood. Secondary outcomes: : Evaluation of changes in
concentrations of selected mediators of inflammatory response (IL-1β, IL-6, TNF and others)
and selected chemokines as markers of the glia damage.
Hemodynamic stability during the surgery, and efficacy of postoperative analgesia will be
also evaluated.
With the approval from the Bioethical Committee of the University of Rzeszow, informed
written consent will be obtained from all patients.
A sample size of 60 patients was calculated to obtain at least 25% reduction of glutamate
concentration in the cerebrospinal fluid in the ropivacaine group with 0,05 significance and
power of 0,8.
Consenting patients, scheduled for orthopaedic surgery under spinal anesthesia will be
randomly (1:1) assigned using closed envelopes to receive intrathecally ropivacaine or
bupivacaine as a single shot before the start of surgery, followed by bolus doses of the same
local anesthetic as required during the surgery, and continuous infusion of the same local
anesthetic for 24 h for postoperative pain relief. All block will be performed in the sitting
position, and the drug will be administered in supine position through the catheter in the
intrathecal space. Blood and cerebrospinal fluid samples will be drawn at predetermined time
intervals centrifuged as required and frosen in -70deg C until analysis.
Eligibility Ages eligible for study 18 years and older (Adult, Senior) Sexes Eligible for the
Study: All Accepts Healthy Volunteers: No
Inclusion Criteria:
Orthopedic procedures in the lower limbs Written informed consent Exclusion criteria
Patients' refusal Known allergies to study medications Anatomic, posttraumatic and
postoperative deformations of the spinal column making placement of intrathecal catheter
impossible Neurological contraindications Any other contraindications for spinal anesthesia
(coagulations disorders, antiplatelet or anticoagulant treatment, infection at the puncture
site.
Inability to comprehend or participate in pain scoring scale
;
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