Clinical trial NCT04881474: The Effects Of Intravenous Ibuprofen on Pain, Oxidative Stress and Inflammation in Laparoscopic Hysterectomy Operations
Official title: The Effects Of Intravenous Ibuprofen on Pain, Oxidative Stress and Inflammation With the Assessment of Thiol-Disulfide Homeostasis and C-Reactive Protein Levels in Laparoscopic Hysterectomy Operations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia; Ibuprofen; Acetaminophen; Oxidative Stress
Lead sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2021-05-11
Enrollment: 69
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Elective Total Laparoscopic Hysterectomy, Aged between 30 and 65, Body Mass Index (BMI) below 35, ASA class I and II

Exclusion Criteria:

* trauma patients to be operated in emergent conditions, ASA risk classification III-IV and more, have a postoperative intensive care indication, Active and clinical symptoms of anemia, Platelet level lower than 30000 / mm3, History of gastrointestinal bleeding in the last 6 months, History of bleeding diathesis or increased Patients at risk of intracerebral hemorrhage, Oliguric and / or need dialysis in the last 1 month before surgery, or have received dialysis, Patients who used a combination of Warfarin, Lithium, Angiotensin Converting Enzyme (ACE) inhibitor and Furosemide medication or who needed to use any analgesic, muscle relaxant or sedative medication within the last 24 hours.

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

Primary outcomes:
measure: Change of native thiol concentration from baseline (preoperative-T0) to each timepoints (T1-T2-T3)
timeFrame: preoperative (T0), 5 minutes before abdominal insufflation (T1), 15 minutes after abdominal desufflation (T2), postoperative 24 th hour (T3)
measure: Change of total thiol concentration from baseline (preoperative-T0) to each timepoints (T1-T2-T3)
timeFrame: preoperative (T0), 5 minutes before abdominal insufflation (T1), 15 minutes after abdominal desufflation (T2), postoperative 24 th hour (T3)
measure: Change of disulfide concentration from baseline (preoperative-T0) to each timepoints (T1-T2-T3)
timeFrame: preoperative (T0), 5 minutes before abdominal insufflation (T1), 15 minutes after abdominal desufflation (T2), postoperative 24 th hour (T3)
measure: Change of disulfide to native thiol ratio from baseline (preoperative-T0) to each timepoints (T1-T2-T3)
timeFrame: preoperative (T0), 5 minutes before abdominal insufflation (T1), 15 minutes after abdominal desufflation (T2), postoperative 24 th hour (T3)
Secondary outcomes:
measure: Change of C-Reactive Protein concentration from baseline (preoperative-T0) to each timepoints (T1-T2-T3)
timeFrame: preoperative (T0), 5 minutes before abdominal insufflation (T1), 15 minutes after abdominal desufflation (T2), postoperative 24 th hour (T3)
measure: Comparing of the pain levels between groups (Group P and Group IP) for each timepoints.
timeFrame: postoperative 1st, 2nd, 6th 12th, 24th hours
measure: Number of patients who needed tramadol for rescue analgesic
timeFrame: From end of the operation to postoperative 24th hours.
measure: Average consumption of tramadol for each patient who needed rescue analgesic.
timeFrame: From end of the operation to postoperative 24th hours.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kartal Dr. Lütfi Kırdar Training and Research Hospital
state: İ̇stanbul
Study officials:
References: