The Effects Of Intravenous Ibuprofen on Pain, Oxidative Stress and Inflammation in Laparoscopic Hysterectomy Operations

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

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 Overview

• Status: Completed
• Conditions: Analgesia; Ibuprofen; Acetaminophen; Oxidative Stress
• Intervention / Treatment: Drug: Ibuprofen 800 mg

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İ̇stanbul
    • Istanbul, İ̇stanbul, Turkey, 34846
      • Kartal Dr. Lütfi Kırdar Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ibuprofen and paracetamol	Drug: Ibuprofen 800 mg; 30-minute lasting iv infusion of 800 mg ibuprofen diluted with 0,9% saline via intravenous route every 6 hours.
Active Comparator: paracetamol only	Drug: Ibuprofen 800 mg; 30-minute lasting iv infusion of 800 mg ibuprofen diluted with 0,9% saline via intravenous route every 6 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)
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.

Collaborators and Investigators

• Sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2020
• Primary Completion (Actual): July 27, 2020
• Study Completion (Actual): December 28, 2020

Study Registration Dates

• First Submitted: February 20, 2021
• First Submitted That Met QC Criteria: May 5, 2021
• First Posted (Actual): May 11, 2021

Study Record Updates

• Last Update Posted (Actual): May 11, 2021
• Last Update Submitted That Met QC Criteria: May 5, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen
• Other Study ID Numbers: LutfiKirdarTRH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: 31.12.2021
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No