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

NCT04881474 | Completed

• 1 other identifier: LutfiKirdarTRH
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesia; Ibuprofen; Acetaminophen; Oxidative Stress

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Change of C-Reactive Protein concentration from baseline (preoperative-T0) to each timepoints (T1-T2-T3)

  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.

  postoperative 1st, 2nd, 6th 12th, 24th hours

• Number of patients who needed tramadol for rescue analgesic

  From end of the operation to postoperative 24th hours.

• Average consumption of tramadol for each patient who needed rescue analgesic.

  From end of the operation to postoperative 24th hours.

Study Arms (2)

ibuprofen and paracetamol

ACTIVE COMPARATOR

Drug: Ibuprofen 800 mg

paracetamol only

ACTIVE COMPARATOR

Drug: Ibuprofen 800 mg

Interventions

Ibuprofen 800 mg DRUG

30-minute lasting iv infusion of 800 mg ibuprofen diluted with 0,9% saline via intravenous route every 6 hours.

ibuprofen and paracetamol; paracetamol only

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Kartal Dr. Lütfi Kırdar Training and Research Hospital

Istanbul, İ̇stanbul, 34846, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: February 20, 2021
• First Posted: May 11, 2021
• Study Start: January 2, 2020
• Primary Completion: July 27, 2020
• Study Completion: December 28, 2020
• Last Updated: May 11, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 31.12.2021

Locations

TU (1)