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Study on the Effectiveness and Safety of Ibuprofen and Tramadol for Patients with Severe Postoperative Pain

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effectiveness and safety of a new treatment for patients experiencing acute severe postoperative pain. The treatment being tested is a combination of two medications: ibuprofen and tramadol hydrochloride. These medications are given together in a single solution through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein. The study aims to determine if this combination can provide better pain relief compared to using tramadol alone or a placebo.

Participants in the study will receive the treatment after undergoing surgery, which may include procedures like myomectomy, hysterectomy, or cholecystectomy. The study will monitor how well the treatment controls pain over a period of several hours. The goal is to see if the combination of ibuprofen and tramadol can manage pain effectively and safely, providing relief without causing significant side effects.

Throughout the study, participants will be closely observed to assess their pain levels and any potential side effects. The study will compare the pain relief provided by the combination treatment to that of tramadol alone and a placebo, ensuring a comprehensive evaluation of its effectiveness. This research is important for developing better pain management strategies for patients recovering from surgery.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient must provide written informed consent, confirming understanding and willingness to comply with the study procedures.

    Eligibility is confirmed based on age, body mass index, and scheduled surgery type, such as myomectomy or hysterectomy.

  2. Step 2

    Post-surgery assessment

    After surgery, the patient's pain level is assessed using a Numeric Rating Scale. A score of 6 or higher is required to proceed with the study.

  3. Step 3

    Randomization and treatment

    The patient is randomly assigned to receive either the study medication, an active comparator, or a placebo.

    The study medication is a combination of ibuprofen (arginate) and tramadol hydrochloride, administered intravenously at a dose of 400-37.5 mg every 4 hours.

  4. Step 4

    Pain assessment

    Pain intensity is measured at baseline and at regular intervals: 1, 2, 3, and 4 hours after the start of treatment.

    The primary goal is to evaluate the change in pain intensity over the first 4 hours.

  5. Step 5

    Extended pain assessment

    Further pain assessments occur at 5, 6, 7, and 8 hours after treatment begins.

    The study examines the overall pain relief and the time taken to achieve significant pain reduction.

  6. Step 6

    Rescue medication

    If necessary, additional medication may be provided to manage pain, and the timing and amount of this rescue medication are recorded.

  7. Step 7

    Safety monitoring

    Throughout the study, vital signs such as body temperature, heart rate, blood pressure, and oxygen levels are monitored.

    Any adverse events are documented to ensure patient safety.

Who can join the trial?

6 criteria

  • Patients must provide written informed consent, which means they agree to participate in the study and understand what it involves.
  • Patients must be 18 years or older at the time of the screening visit.
  • Patients must have a body mass index (BMI) of 18.5 or higher but less than 40. BMI is a measure of body fat based on height and weight.
  • Patients must be scheduled for certain types of surgeries, such as myomectomy, hysterectomy (total or partial), oophorectomy, salpingo-oophorectomy, cholecystectomy, haemorrhoidectomy, or tonsillectomy. These are different types of surgical procedures.
  • Patients must have an American Society of Anesthesiologists (ASA) anaesthesia risk score of I or II. This score indicates the patient's health status before surgery, with I being a healthy patient and II having mild systemic disease.
  • After surgery and before being randomly assigned to a treatment group, patients must have a pain score of 6 or higher on the Numeric Rating Scale (NRS). This scale is used to measure pain intensity, with higher numbers indicating more severe pain.

Who cannot join the trial?

9 criteria

  • Patients who are allergic to any of the study medications, such as ibuprofen or tramadol, cannot participate.
  • Individuals with a history of severe allergic reactions to similar medications are excluded.
  • Patients with certain medical conditions that could interfere with the study or put them at risk are not eligible.
  • Participants who are currently taking medications that might interact with the study drugs are excluded.
  • Individuals with a history of drug or alcohol abuse may not participate.
  • Pregnant or breastfeeding women are not allowed to join the study.
  • Patients with severe liver or kidney problems are excluded.
  • Individuals who have participated in another clinical trial recently may not be eligible.
  • Patients who are unable to follow the study procedures or attend follow-up visits are excluded.
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Investigated drugs

  • Ibuprofen

    is a medication commonly used to relieve pain, reduce inflammation, and lower fever. In this trial, it is combined with another medication to help manage severe postoperative pain.

  • Tramadol

    is a pain reliever that works in the brain to change how your body feels and responds to pain. It is often used for moderate to severe pain and is being tested in combination with ibuprofen in this trial to see if it provides effective pain relief after surgery.

What is already known about the treatment

Ibuprofen (Arginate)-Tramadol Hydrochloride – This medication is administered intravenously and is currently being evaluated in a Phase III clinical trial for its effectiveness in managing acute severe postoperative pain. It is a combination of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), and tramadol, an opioid analgesic. The main therapeutic indication is to provide pain relief after surgery. Ibuprofen works by reducing inflammation and blocking the production of certain chemicals in the body that cause pain, while tramadol alters the way the brain perceives pain by binding to specific receptors. This combination aims to offer effective pain control with potentially fewer side effects than higher doses of either drug alone.

Investigated diseases

Acute Pain – Acute pain is a sudden onset of discomfort that typically results from injury, surgery, or inflammation. It serves as a warning signal to the body, indicating that something is wrong. This type of pain is usually sharp and intense, but it can vary in severity. It often resolves once the underlying cause is treated or heals. Acute pain can be localized to a specific area or more generalized, depending on the source. It is a temporary condition, distinct from chronic pain, which persists over a longer period.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505687-11-00Protocol codeFMLD-FEBETRADI-53_FIEstimated enrolment216 patientsSponsorFarmalider S.A.

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