Fixed Combination of Dipyrone and Codeine for Controlling Pain After Pelvic-abdominal Surgery (NCT04641338) | Clinical Trial Compass
CompletedPhase 3
Fixed Combination of Dipyrone and Codeine for Controlling Pain After Pelvic-abdominal Surgery
Brazil491 participantsStarted 2023-03-16
Plain-language summary
Phase III clinical trial, multicentre, superiority, randomized, open, parallel groups, with active control and use of postoperative oral medication (multiple doses of medication).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Men or women aged 18 years or older;
* Be able to sign the ICF approved by the IEC and to perform and understand all the study procedures and instructions;
* Show post-anesthesia recovery with a score greater than or equal to 8 on the modified Aldrete and Kroulik Scale;
* Experience pain intensity according to the visual analogue scale (VAS) of 3.0 to 10 cm (moderate to severe pain) immediately after surgery;
* Have an elective open abdominal-pelvic surgery scheduled, not due to malignant neoplasm, to be performed within 4 weeks of screening;
* Estimated hospital stay for at least 48 hours after the procedure.
Exclusion Criteria:
* Surgical complications during participant enrollment in the research;
* Surgery with indication for treatment of confirmed or suspected malignant neoplasm;
* Chronic use of any non-steroidal anti-inflammatory drugs;
* Suspected paralytic ileus or intestinal obstruction;
* Inability to use oral drugs postoperatively;
* Videolaparoscopic surgery;
* History of chronic and current use of opioids or other analgesics;
* Use of concomitant modalities of intravenous or neuraxial analgesia (spinal and epidural) with placement of an epidural catheter for use in the postoperative period, or regional blockade, where the expected duration of analgesia administered intravenously or neuroaxially is maintained after 24 hours of the surgical procedure or randomization, whichever occurs first;
* Use of immunosuppressive therapy in the last 2…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of participants achieving at least 50% of maximum pain relief within 6 hours