Beta-endorphin, Dipyrone, Hernia Surgery, Pain
Conditions
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).
Interventions
DRUGDipyrone administration
Dipyrone 2 g (Nolotil®, Europharma, Madrid, Spain); one ampoule in 50 mL of 0.9% saline solution as an intravenous infusion over 10 min.
BEHAVIORALPain assessment
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).
BIOLOGICALbeta-endorphin immunoreactivity
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.
OTHERPlacebo administration
Placebo in 50 mL of 0.9% saline solution as an intravenous infusion over 10 min.
Sponsors
Antonio Martín Duce
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors and data analysts will be kept blinded to the allocation.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analgesic efficacy-Pain relief | 30 seconds | Visual Analogue Scale score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Beta-endorphins levels. | 1 minute | Beta-endorphin immunoreactivity levels |
Countries
Spain
Outcome results
None listed