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

NCT04881474 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2021-05-11

No results posted yet for this study

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

Interventions

DRUG

Ibuprofen 800 mg

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

Sponsors & Collaborators

  • Dr. Lutfi Kirdar Kartal Training and Research Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-02
Primary Completion
2020-07-27
Completion
2020-12-28

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04881474 on ClinicalTrials.gov