Fixed Combination of Dipyrone and Codeine for Controlling Pain After Pelvic-abdominal Surgery (DIPICOR)

May 5, 2026 updated by: Brazilian Clinical Research Institute

Randomized, Multicentre, Superiority Clinical Trial to Assess the Combination of Fixed Dosage Dipyrone and Codeine Compared to the Isolated Use of Components in the Control of Pain After Open Pelvic-abdominal Surgery

Phase III clinical trial, multicentre, superiority, randomized, open, parallel groups, with active control and use of postoperative oral medication (multiple doses of medication).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The main objective is to evaluate the effectiveness and safety of the association in relation to the isolated use of medicines.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
491

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Brazil
    • Rio Grande do Sul
      • Ijuí, Rio Grande do Sul, Brazil
        • Associação Hospital de Caridade Ijuí - Núcleo de Ensino e Pesquisa
    • São Paulo
      • Bragança Paulista, São Paulo, Brazil
        • Hospital Universitário São Francisco na Providência de Deus
      • Votuporanga, São Paulo, Brazil
        • Santa Casa de Misericórdia de Votuporanga

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 24 hours prior to surgery;
  • Participants with uncontrollable vomiting present in the postoperative period;
  • Abusive user of alcohol or illicit drugs;
  • Use of drugs with potential interaction with the study drugs;
  • Allergy, hypersensitivity, or known contraindication to the use of ingredients of the study drug;
  • Psychiatric or social disorders that prevent the appropriate compliance with the protocol;
  • Demonstrate inability to understand and perform current pain assessments in the study;
  • Women who are pregnant, breastfeeding, planning to become pregnant, or who have a positive urine pregnancy test.
  • Participants who test positive for COVID-19 (upon presentation of the test report at the time of screening or prior to randomization);
  • Participation in another clinical trial within less than one year (unless the participation is warranted by the principal investigator);
  • Presence of decompensated diabetes mellitus;
  • History of decompensated obstructive or restrictive respiratory disease;
  • Current symptoms or past history of gastrointestinal bleeding;
  • History of blood dyscrasia or chronic disease of any nature that contraindicates the participant's participation at the investigator's discretion;
  • Inability to understand and perform the pain assessments during the study;
  • Hypersensitivity or contraindication to the use of ingredients of the study drugs;
  • Grade III obesity (BMI above 40);
  • Presence of one or more flu-like symptoms, such as: fever, cough, dyspnea, myalgia and fatigue, respiratory symptoms, gastrointestinal symptoms (such as diarrhea) within 14 days prior to the screening or randomization visit;
  • Other serious comorbidities at the investigators' discretion (such as history of renal, hepatic, cardiac or other peptic ulcer);
  • Any clinical condition that the investigator considers to pose a risk to the patient or interfere with study conduction.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Dipyrone
Drug: Dipyrone
use of 1000 mg dipyrone every 6 hours
Experimental: Combination therapy group
Drug: Fixed dose combination Dipyrone and Codeine
Fixed dose combination: dipyrone 1000 mg + codeine 30 mg every 6 hours
Active Comparator: Codeine
Drug: Codeine
30 mg codeine every 6 hours.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of participants achieving at least 50% of maximum pain relief within 6 hours
Time Frame: 6 hours
Proportion of participants achieving at least 50% of maximum pain relief within 6 hours after first drug administration, through the assessment of total pain relief (TOTPAR) after first drug administration. TOTPAR is calculated from the result of the 5-point categorical pain relief scale (adapted PAR scale, with the 5 categories: 1-no relief, 2-mild relief, 3-moderate relief, 4-a lot of relief, and 5-complete relief). The PAR will be evaluated 30 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours after drug administration, so that the TOTPAR can take into account the progress of pain relief at 8 different timepoints.
6 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of satisfaction with treatment by the participant
Time Frame: 14 days
Assessment of satisfaction with treatment by the participant using a standard categorical rating scale: Patient-reported global evaluation of Eficacy (PGE) scale of 5-points where 0=poor, 1=fair, 2=good , 3=very good, and 5=excellent response to therapy).
14 days
Presence of adverse events
Time Frame: 14 days
14 days
Pain assessment by the visual analogic scale score
Time Frame: 6 hours
The average visual analogic scale score (visual analogic scale from 0 to 10 cm, where 0 = no pain and 10 = the worst imaginable pain) measured at rest and during handling in subsequent medication.
6 hours
Proportion of participants who achieve at least 50% pain reduction
Time Frame: 6 hours
Assessment of the proportion of participants who achieve at least 50% pain reduction within 6 hours, through assessment of SPID (sum of the pain intensity difference) after the first dose of study drugs;
6 hours
Assessment of complete pain relief
Time Frame: 72 hours
Assessment of complete pain relief by verbal scale assessment of pain relief (VRS where 0 = no pain relief, 1 = mild pain relief, 2 = moderate pain relief, 3 = good pain relief, and 4 = excellent pain relief).
72 hours
Time to pain relief
Time Frame: During hospitalization
Median time to pain relief
During hospitalization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brazilian Clinical Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Brainfarma Industria Química e Farmacêutica S/A

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 16, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 17, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 7, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 23, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 03/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The data may be shared with other parties upon reasonable request to the corresponding author of the publications and after agreement with the sponsor.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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