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

NCT ID: NCT04881474

Last Updated: 2021-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-02
• Study Completion Date: 2020-12-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

ibuprofen and paracetamol

Group Type: ACTIVE_COMPARATOR

Ibuprofen 800 mg

Intervention Type: DRUG

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

paracetamol only

Group Type: ACTIVE_COMPARATOR

Ibuprofen 800 mg

Intervention Type: DRUG

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

Interventions

Ibuprofen 800 mg

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Dr. Lutfi Kirdar Kartal Training and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ersin Kahraman

Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kartal Dr. Lütfi Kırdar Training and Research Hospital

Istanbul, İ̇stanbul, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

LutfiKirdarTRH

Identifier Type: -

Identifier Source: org_study_id