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

Primary Purpose

Analgesia; Ibuprofen; Acetaminophen; Oxidative Stress

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Ibuprofen 800 mg
Sponsored by
Dr. Lutfi Kirdar Kartal Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Analgesia; Ibuprofen; Acetaminophen; Oxidative Stress

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Kartal Dr. Lütfi Kırdar Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ibuprofen and paracetamol

paracetamol only

Arm Description

Outcomes

Primary Outcome Measures

Change of native thiol concentration from baseline (preoperative-T0) to each timepoints (T1-T2-T3)
oxidative stress determination with native thiol values
Change of total thiol concentration from baseline (preoperative-T0) to each timepoints (T1-T2-T3)
oxidative stress determination with total thiol values
Change of disulfide concentration from baseline (preoperative-T0) to each timepoints (T1-T2-T3)
oxidative stress determination with disulfide values
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

Secondary Outcome Measures

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.
Comparing of the pain levels between groups (Group P and Group IP) for each timepoints.
Pain level measured by Visual Analogue Scale
Number of patients who needed tramadol for rescue analgesic
Determination of patient number who needs rescue analgesic (tramadol).
Average consumption of tramadol for each patient who needed rescue analgesic.
Determination of average tramadol dose as milligrams

Full Information

First Posted
February 20, 2021
Last Updated
May 5, 2021
Sponsor
Dr. Lutfi Kirdar Kartal Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04881474
Brief Title
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
January 2, 2020 (Actual)
Primary Completion Date
July 27, 2020 (Actual)
Study Completion Date
December 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr. Lutfi Kirdar Kartal Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia; Ibuprofen; Acetaminophen; Oxidative Stress

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ibuprofen and paracetamol
Arm Type
Active Comparator
Arm Title
paracetamol only
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ibuprofen 800 mg
Intervention Description
30-minute lasting iv infusion of 800 mg ibuprofen diluted with 0,9% saline via intravenous route every 6 hours.
Primary Outcome Measure Information:
Title
Change of native thiol concentration from baseline (preoperative-T0) to each timepoints (T1-T2-T3)
Description
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)
Title
Change of total thiol concentration from baseline (preoperative-T0) to each timepoints (T1-T2-T3)
Description
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)
Title
Change of disulfide concentration from baseline (preoperative-T0) to each timepoints (T1-T2-T3)
Description
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)
Title
Change of disulfide to native thiol ratio from baseline (preoperative-T0) to each timepoints (T1-T2-T3)
Description
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)
Secondary Outcome Measure Information:
Title
Change of C-Reactive Protein concentration from baseline (preoperative-T0) to each timepoints (T1-T2-T3)
Description
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)
Title
Comparing of the pain levels between groups (Group P and Group IP) for each timepoints.
Description
Pain level measured by Visual Analogue Scale
Time Frame
postoperative 1st, 2nd, 6th 12th, 24th hours
Title
Number of patients who needed tramadol for rescue analgesic
Description
Determination of patient number who needs rescue analgesic (tramadol).
Time Frame
From end of the operation to postoperative 24th hours.
Title
Average consumption of tramadol for each patient who needed rescue analgesic.
Description
Determination of average tramadol dose as milligrams
Time Frame
From end of the operation to postoperative 24th hours.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Kartal Dr. Lütfi Kırdar Training and Research Hospital
City
Istanbul
State/Province
İ̇stanbul
ZIP/Postal Code
34846
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
31.12.2021

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

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