Phase III clinical trial of superiority, randomized, multicentre, blind, parallel, to evaluate the efficacy and safety of Lisador® (Cosmed) compared to Novalgina® 500mg (Sanofi-Medley) in the treatment of postoperative pain in abdominal-pelvic videolaparoscopy

Phase 3

• Conditions: postoperative pain in abdomino- pelvic; C23.888.592.612

• Registration Number: RBR-287dkz
• Lead Sponsor: Brainfarma Indústria Química e Farmacêutica S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-04
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Sign the TCLE;
-Men and women, aged 18 or over;
-To present pain evaluation by the pain intensity scale: from 3,0 to 7,9 cm;
- Having undergone elective surgery by abdominal-pelvic videolaparoscopy, not due to malignancy;
- Schedule to be discharged within 24 hours of the end of the surgical procedure;

Exclusion Criteria

• Presence of infection associated with the condition, except for appendectomy;
• Surgery with indication for treatment of confirmed or suspected malignancy;
• Laparoscopic surgery that required conversion to open surgery;
• Use of opioids in the last 8 hours of signing the informed consent form;
• Chronic use of painkillers regularly for other reasons;
• Use of corticosteroids;
• Chronic use of any non-steroidal anti-inflammatory;
• Use of immunosuppressive therapy;
• Participants with a vomiting condition present at the time of signing the informed consent form;
• Presence of decompensated diabetes mellitus;
• History of decompensated obstructive or restrictive respiratory disease;
• History of blood dyscrasia or chronic disease of any nature that contraindicates the participation of the participant at the discretion of the investigator;
• Inability to understand and perform pain assessments in the study;
• Hypersensitivity or contraindication for use of the studied medication components;
•Morbid obesity;
• Pregnant women;
• Present one or more flu-like symptoms such as: fever, cough, dyspnoea, myalgia and fatigue, respiratory symptoms, gastrointestinal symptoms (such as diarrhea) within 14 days prior to the screening visit;
• Participation in another clinical study in less than 1 year.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint of effectiveness will be the proportion of participants who achieve at least 50% of maximum pain relief within 6 hours, through the assessment of total pain relief (TOTPAR) at the following times: 30min, 1h, 1h30min, 2h, 3h, 4h, 5h and 6h after the first medication.

Secondary Outcome Measures

Name	Time	Method
1. Pain assessment using the Visual Analogue Scale (VAS) at 30min, 1h, 1h30min, 2h, 3h, 4h, 5h and 6h after taking the medications, comparing with baseline pain;<br>2. Assessment of the proportion of participants who achieve at least 50% of pain reduction within 6 hours, through SPID (sum of the pain intesity difference) assessment after taking medications.<br>3. Evaluation of the proportion of participants who show improvement in pain at the end of treatment, compared to baseline pain;<br>4. Assessment of the time required for pain improvement;<br>5. Overall assessment of treatment using the 5-point scale (poor, regular, good, very good and excellent), to be completed by the participant in the final visit.<br>6. Overall assessment of treatment using the 5-point scale (poor, regular, good, very good and excellent), to be completed by the investigator at the final visit.<br>The security objective:<br>Assessment of adverse events during the study period.