PainPhase 4NCT04595877
Double-blind, Randomized Controlled Study to Assess the Analgesic Effect of 2 g of Magnesium Dipyrone (Metamizol) and Changes in Plasma Beta-endorphin Immunoreactivity Values in Patients Undergoing Elective Inguinal Herniorrhaphy Under Epidural Anesthesia.
A Phase 4 study testing Dipyrone administration, Pain assessment and beta-endorphin immunoreactivity in people with Pain and Beta-endorphin, run by Antonio Martín Duce at 1 site in Spain.
Trial summary
A double-blind, randomized controlled study is designed to assess the analgesic effect of a single intravenous dose of 2 g of magnesium dipyrone (metamizol) and whether the administration of the active drug will be associated with changes in plasma beta-endorphin immunoreactivity values in patients undergoing elective… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain, Beta-endorphin, Dipyrone
- What is being tested?
- Dipyrone administration, Pain assessment and beta-endorphin immunoreactivity
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2006to May 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-70 years, elective surgery, routine laboratory tests (blood cell count, biochemical profile, urinalysis), chest radiography, twelve-lead electrocardiography, body mass index (BMI), blood pressure, pulse rate normal or abnormal values without clinical relevance and a mental status sufficient to be able to complete efficacy tests.
Who cannot join
- Patients who had taken other analgesics or anti-inflammatory drugs 24 h before surgery, as those with known hypersensitivity to the drug or with any other disorder contradicting the administration of dipyrone. Patients with hypersensitivity to non-steroidal anti-inflammatory agents.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Nursing and Physiotherapy Department
Madrid, Alcalá de Henares, 28805
About this study
Official title: Double-blind, Randomized Controlled Study to Assess the Analgesic Effect of a Single Intravenous Dose of 2 g of Magnesium Dipyrone (Metamizol) and Changes in Plasma Beta-endorphin Immunoreactivity (Beta-EPIr) Values in Patients Undergoing Elective Inguinal Herniorrhaphy (Bassini Operation) Under Epidural Anesthesia.
A double-blind, randomized controlled study is designed to assess the analgesic effect of a single intravenous dose of 2 g of magnesium dipyrone (metamizol) and whether the administration of the active drug will be associated with changes in plasma beta-endorphin immunoreactivity values in patients undergoing elective inguinal herniorrhaphy (Bassini operation) under epidural anesthesia. Participants, care givers, and those assessing the outcomes will be blinded to group assignment. Participants will be randomized to receive dipyrone or a placebo. The active drug or placebo will be administered as an intravenous infusion over 10 min. Pain will be evaluated by the patient according to a 100-mm visual analogue scale. Assessments will be carried out the day before surgery, immediately after operation, at the time of drug administration, and 60 and 180 min after treatment. At the same time as pain will be evaluated, blood samples will be drawn for plasma beta-endorphin immunoreactivity measurement (immunoradiometric assay).
- Conditions
- Pain, Beta-endorphin, Dipyrone, Hernia Surgery
- Being tested
- Dipyrone administration, Pain assessment, beta-endorphin immunoreactivity, Placebo administration
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dipyrone administrationDrug
Dipyrone 2 g (Nolotil®, Europharma, Madrid, Spain); one ampoule in 50 mL of 0.9% saline solution as an intravenous infusion over 10 min.
Pain assessmentBehavioural
Pain will be evaluated by the patient according to a 100-mm visual analogue scale (VAS) (from point 0 "no pain" to point 10 "unbearable pain").
beta-endorphin immunoreactivityBiological
Plasma beta-EPIr levels will be measured by an immunoradiometric assay (Allegro Beta-endorphin, Nichols Institute Diagnostics, SAN JUAN DE CAPISTRANO, CA) (normal values 29-40 pg/mL). It will be obtained by venous blood samples (5 mL) at the same time points at pain will be measured.
Placebo administrationOther
Placebo in 50 mL of 0.9% saline solution as an intravenous infusion over 10 min.
| Study group | Role | What they receive |
|---|---|---|
| Dipyrone group | Experimental | Dipyrone 2 g (Nolotil®, Europharma, Madrid, Spain); one ampoule in 50 mL of 0.9% saline solution as an intravenous infusion over 10 min. Receives: Drug: Dipyrone administration; Behavioral: Pain assessment; Biological: beta-endorphin immunoreactivity |
| Placebo group | Placebo comparator | The placebo will be matched to the study drug for, color, and size. Placebo will be administered in a single dose in 50 mL of 0.9% saline solution as an intravenous infusion over 10 min. Receives: Behavioral: Pain assessment; Biological: beta-endorphin immunoreactivity; Other: Placebo administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic efficacy-Pain relief
Visual Analogue Scale score
Measured: 30 seconds
Secondary outcomes (1)
Beta-endorphins levels.
Beta-endorphin immunoreactivity levels
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study startJan 2006
- Primary completionMay 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antonio Martín Duce
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Antonio Martín Duce, University of Alcala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04595877
- Sponsor's protocol ID
- 1093-10
- Status last verified
- Oct 2020
- First submitted
- 23 Sep 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized Controlled Study to Assess the Analgesic Effect of a Single Intravenous Dose of 2 g of Magnesium Dipyrone (Metamizol) and Changes in Plasma Beta-endorphin Immunoreactivity (Beta-EPIr) Values in Patients Undergoing Elective Inguinal Herniorrhaphy (Bassini Operation) Under Epidural Anesthesia.
- ClinicalTrials.gov ID
- NCT04595877
- Acronym / sponsor ID
- 1093-10
- Conditions
- Pain, Beta-endorphin, Dipyrone, Hernia Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Antonio Martín DuceUniversity, hospital or other
- Study start
- Jan 2006 (actual)
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A double-blind, randomized controlled study is designed to assess the analgesic effect of a single intravenous dose of 2 g of magnesium dipyrone (metamizol) and whether the administration of the active drug will be associated with changes in plasma beta-endorphin immunoreactivity values in patients undergoing elective inguinal herniorrhaphy (Bassini operation) under epidural anesthesia. Participants, care givers, and those assessing the outcomes will be blinded to group assignment. Participants will be randomized to receive dipyrone or a placebo. The active drug or placebo will be administered as an intravenous infusion over 10 min. Pain will be evaluated by the patient according to a 100-mm visual analogue scale. Assessments will be carried out the day before surgery, immediately after operation, at the time of drug administration, and 60 and 180 min after treatment. At the same time as pain will be evaluated, blood samples will be drawn for plasma beta-endorphin immunoreactivity measurement (immunoradiometric assay).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dipyrone group | Experimental | Drug: Dipyrone administration, Behavioral: Pain assessment, Biological: beta-endorphin immunoreactivityDipyrone 2 g (Nolotil®, Europharma, Madrid, Spain); one ampoule in 50 mL of 0.9% saline solution as an intravenous infusion over 10 min. |
| Placebo group | Placebo comparator | Behavioral: Pain assessment, Biological: beta-endorphin immunoreactivity, Other: Placebo administrationThe placebo will be matched to the study drug for, color, and size. Placebo will be administered in a single dose in 50 mL of 0.9% saline solution as an intravenous infusion over 10 min. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18-70 years, elective surgery, routine laboratory tests (blood cell count, biochemical profile, urinalysis), chest radiography, twelve-lead electrocardiography, body mass index (BMI), blood pressure, pulse rate normal or abnormal values without clinical relevance and a mental status sufficient to be able to complete efficacy tests.
Key exclusion criteria (1 listed)
- Patients who had taken other analgesics or anti-inflammatory drugs 24 h before surgery, as those with known hypersensitivity to the drug or with any other disorder contradicting the administration of dipyrone. Patients with hypersensitivity to non-steroidal anti-inflammatory agents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dipyrone administrationDipyrone 2 g (Nolotil®, Europharma, Madrid, Spain); one ampoule in 50 mL of 0.9% saline solution as an intravenous infusion over 10 min. | Drug | Dipyrone group |
| Pain assessmentPain will be evaluated by the patient according to a 100-mm visual analogue scale (VAS) (from point 0 "no pain" to point 10 "unbearable pain"). | Behavioural | Dipyrone group, Placebo group |
| beta-endorphin immunoreactivityPlasma beta-EPIr levels will be measured by an immunoradiometric assay (Allegro Beta-endorphin, Nichols Institute Diagnostics, SAN JUAN DE CAPISTRANO, CA) (normal values 29-40 pg/mL). It will be obtained by venous blood samples (5 mL) at the same time points at pain will be measured. | Biological | Dipyrone group, Placebo group |
| Placebo administrationPlacebo in 50 mL of 0.9% saline solution as an intravenous infusion over 10 min. | Other | Placebo group |
Primary outcome
Analgesic efficacy-Pain relief
Time frame: 30 seconds
Visual Analogue Scale score
1 secondary outcome
Beta-endorphins levels.
Time frame: 1 minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dipyrone administration, Pain assessment and beta-endorphin immunoreactivity in people with Pain and Beta-endorphin, run by Antonio Martín Duce at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analgesic efficacy-Pain relief (time frame: 30 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.