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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ibuprofen and paracetamol | Active Comparator |
| |
| paracetamol only | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen 800 mg | Drug | 30-minute lasting iv infusion of 800 mg ibuprofen diluted with 0,9% saline via intravenous route every 6 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of native thiol concentration from baseline (preoperative-T0) to each timepoints (T1-T2-T3) | oxidative stress determination with native thiol values | 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 | 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 | 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 | preoperative (T0), 5 minutes before abdominal insufflation (T1), 15 minutes after abdominal desufflation (T2), postoperative 24 th hour (T3) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | preoperative (T0), 5 minutes before abdominal insufflation (T1), 15 minutes after abdominal desufflation (T2), postoperative 24 th hour (T3) |
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Inclusion Criteria:
Exclusion Criteria:
Patients who had a hypersensitivity reaction to any anesthetic or analgesic drug to be used in the study Patients did not want to participate in the study
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kartal Dr. Lütfi Kırdar Training and Research Hospital | Istanbul | İ̇stanbul | 34846 | Turkey (Türkiye) |
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31.12.2021
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| Comparing of the pain levels between groups (Group P and Group IP) for each timepoints. |
Pain level measured by Visual Analogue Scale |
| 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). | 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 | From end of the operation to postoperative 24th hours. |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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