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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.

Primary Purpose

Pain, Beta-endorphin, Dipyrone

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Dipyrone administration
Pain assessment
beta-endorphin immunoreactivity
Placebo administration
Sponsored by
Antonio Martín Duce
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Nursing and Physiotherapy Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dipyrone group

Placebo group

Arm Description

Dipyrone 2 g (Nolotil®, Europharma, Madrid, Spain); one ampoule in 50 mL of 0.9% saline solution as an intravenous infusion over 10 min.

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.

Outcomes

Primary Outcome Measures

Analgesic efficacy-Pain relief
Visual Analogue Scale score

Secondary Outcome Measures

Beta-endorphins levels.
Beta-endorphin immunoreactivity levels

Full Information

First Posted
September 23, 2020
Last Updated
October 20, 2020
Sponsor
Antonio Martín Duce
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1. Study Identification

Unique Protocol Identification Number
NCT04595877
Brief Title
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.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
January 2006 (Actual)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Antonio Martín Duce

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Beta-endorphin, Dipyrone, Hernia Surgery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Outcome assessors and data analysts will be kept blinded to the allocation.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dipyrone group
Arm Type
Experimental
Arm Description
Dipyrone 2 g (Nolotil®, Europharma, Madrid, Spain); one ampoule in 50 mL of 0.9% saline solution as an intravenous infusion over 10 min.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dipyrone administration
Intervention Description
Dipyrone 2 g (Nolotil®, Europharma, Madrid, Spain); one ampoule in 50 mL of 0.9% saline solution as an intravenous infusion over 10 min.
Intervention Type
Behavioral
Intervention Name(s)
Pain assessment
Intervention Description
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").
Intervention Type
Biological
Intervention Name(s)
beta-endorphin immunoreactivity
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo administration
Intervention Description
Placebo in 50 mL of 0.9% saline solution as an intravenous infusion over 10 min.
Primary Outcome Measure Information:
Title
Analgesic efficacy-Pain relief
Description
Visual Analogue Scale score
Time Frame
30 seconds
Secondary Outcome Measure Information:
Title
Beta-endorphins levels.
Description
Beta-endorphin immunoreactivity levels
Time Frame
1 minute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Nursing and Physiotherapy Department
City
Madrid
State/Province
Alcalá De Henares
ZIP/Postal Code
28805
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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.

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