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.

NCT04595877 | Completed Phase 4

• 1 other identifier: 1093-10
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Pain; Beta-endorphin; Dipyrone; Hernia Surgery

Outcome Measures

Primary Outcomes (1)

• Analgesic efficacy-Pain relief

  Visual Analogue Scale score

  30 seconds

Secondary Outcomes (1)

• Beta-endorphins levels.

  1 minute

Study Arms (2)

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.

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.

Behavioral: Pain assessment; Biological: beta-endorphin immunoreactivity; Other: Placebo administration

Interventions

Dipyrone administration DRUG

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

Dipyrone group

Pain assessment BEHAVIORAL

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").

Dipyrone group; Placebo group

beta-endorphin immunoreactivity BIOLOGICAL

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.

Dipyrone group; Placebo group

Placebo administration OTHER

Placebo in 50 mL of 0.9% saline solution as an intravenous infusion over 10 min.

Placebo group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Antonio Martín Duce: lead

Study Sites (1)

Nursing and Physiotherapy Department

Madrid, Alcalá de Henares, 28805, Spain

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors and data analysts will be kept blinded to the allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. Antonio Martin Duce

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: October 22, 2020
• Study Start: January 1, 2006
• Primary Completion: May 1, 2006
• Study Completion: May 1, 2006
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)