Objective: The aim of this study is to evaluate whether the exposure of oxidative stres in the peroperative period and the postoperative 24th hour can be decreased with the thiol-disulfide homeostasis (TDH) method and C-Reactive Protein (CRP) with intravenous ibuprofen used for postoperative analgesia in patients undergoing total laparoscopic hysterectomy Material and Method: Sixty-nine patients with American Society of Anesthesiologists (ASA) scores I and II who scheduled for laparoscopic hysterectomy were included in the study. The patients were randomly divided into two groups as ibuprofen and paracetamol (Group IP) and paracetamol (Group P) with the sealed envelope method. When the vascular access was established from all patients (T0), after blood was drawn for TDH and CRP measurements, while 30-minute lasting iv infusion of 800 mg ibuprofen diluted with 0,9% isotonic and iv infusion of 1 g paracetamol was started simultaneously, only 1g of paracetamol infusion was administered in Group P. In the IP group 800 mg ibuprofen and 1 g paracetamol, in the P group only paracetamol, the medicines specified for each group administered intravenously every 6 hours. The postoperative pain level in the patients was evaluated at the 1st, 2nd, 6th, 12th and 24th hours with the Visual Analogue Scale (VAS). Rescue analgesia with 1mg/kg tramadol as an iv bolus was applied to patients whose VAS score was 4 and above. Other blood samples for CRP and TDH were taken before insufflation (T1), after desufflation (T2) and at the postoperative 24th hour (T3). Demographic and hemodynamic data of the patients, duration of anesthesia and Trendelenburg position, need for additional analgesia, presence of nausea and vomiting, VAS scores, pathology results, CRP and TDH levels were recorded.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
69
30-minute lasting iv infusion of 800 mg ibuprofen diluted with 0,9% saline via intravenous route every 6 hours.
Kartal Dr. Lütfi Kırdar Training and Research Hospital
Istanbul, İ̇stanbul, Turkey (Türkiye)
Change of native thiol concentration from baseline (preoperative-T0) to each timepoints (T1-T2-T3)
oxidative stress determination with native thiol values
Time frame: preoperative (T0), 5 minutes before abdominal insufflation (T1), 15 minutes after abdominal desufflation (T2), postoperative 24 th hour (T3)
Change of total thiol concentration from baseline (preoperative-T0) to each timepoints (T1-T2-T3)
oxidative stress determination with total thiol values
Time frame: preoperative (T0), 5 minutes before abdominal insufflation (T1), 15 minutes after abdominal desufflation (T2), postoperative 24 th hour (T3)
Change of disulfide concentration from baseline (preoperative-T0) to each timepoints (T1-T2-T3)
oxidative stress determination with disulfide values
Time frame: preoperative (T0), 5 minutes before abdominal insufflation (T1), 15 minutes after abdominal desufflation (T2), postoperative 24 th hour (T3)
Change of disulfide to native thiol ratio from baseline (preoperative-T0) to each timepoints (T1-T2-T3)
oxidative stress determination with disulfide to native thiol ratio
Time frame: preoperative (T0), 5 minutes before abdominal insufflation (T1), 15 minutes after abdominal desufflation (T2), postoperative 24 th hour (T3)
Change of C-Reactive Protein concentration from baseline (preoperative-T0) to each timepoints (T1-T2-T3)
Determination of the change of inflammatory response with C-Reactive Protein levels.
Time frame: preoperative (T0), 5 minutes before abdominal insufflation (T1), 15 minutes after abdominal desufflation (T2), postoperative 24 th hour (T3)
Comparing of the pain levels between groups (Group P and Group IP) for each timepoints.
Pain level measured by Visual Analogue Scale
Time frame: postoperative 1st, 2nd, 6th 12th, 24th hours
Number of patients who needed tramadol for rescue analgesic
Determination of patient number who needs rescue analgesic (tramadol).
Time frame: From end of the operation to postoperative 24th hours.
Average consumption of tramadol for each patient who needed rescue analgesic.
Determination of average tramadol dose as milligrams
Time frame: From end of the operation to postoperative 24th hours.
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