Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Analgesic efficacy-Pain relief | Visual Analogue Scale score | 30 seconds |
| Measure | Description | Time Frame |
|---|---|---|
| Beta-endorphins levels. | Beta-endorphin immunoreactivity levels | 1 minute |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nursing and Physiotherapy Department | Madrid | Alcalá de Henares | 28805 | Spain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Outcome assessors and data analysts will be kept blinded to the allocation.
| 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"). |
|
| 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. |
|
| Placebo administration | Other | Placebo in 50 mL of 0.9% saline solution as an intravenous infusion over 10 min. |
|
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided