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A double-blind, randomized trial of ARNICA comp.-Heel treatment in patients undergoing hemorrhoidectomy in day surgery: evaluation of postoperative pain - AREM07

A double-blind, randomized trial of ARNICA comp.-Heel treatment in patients undergoing hemorrhoidectomy in day surgery: evaluation of postoperative pain - AREM07

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-003666-26-IT
Enrollment
Unknown
Registered
2010-03-01
Start date
2010-01-12
Completion date
Unknown
Last updated
2012-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients undergoing hemorrhoidectomy in day surgery MedDRA version: 9.1 Level: SOC Classification code 10042613

Interventions

Trade Name: TRAUMEEL s Pharmaceutical Form: Tablet Other descriptive name: ARNICA Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 294- Pharmaceutical form of the pl

Sponsors

AZIENDA OSPEDALIERA OSPEDALE NIGUARDA CA` GRANDA (A.O. DI RILIEVO NAZIONALE)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Male and female adult (age 18-70 years); - patients scheduled for Milligan-Morgan hemorrhoidectomy, without anal divulsion, , for symptomatic second, third, or fourth degree hemorrhoids (according to the A.S.C.R.S. Classification) - in elective surgery; - in spinal anesthesia; - in day surgery; - written informed consent obtained. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Hemorrhoids associated with other local diseases (i.e. abscess, neoplasm, anal fistula or fissure) - Stapled haemorrhoidopexy (sec. Longo) - controindications to spinal anesthesia - hypersensitivity to one of drugs in protocol - severe cardiac failure and ischemic heart disease - severe respiratory disease - severe hepatic disease - creatininemia > 2 mg/dl - pregnant and/or lacting females - no written informed consent obtained

Design outcomes

Primary

MeasureTime frame
Main Objective: Primary: to evaluate the efficacy of prolonged Arnica comp.-Heel tablets treatment in reducing postoperative pain intensity in outpatients undergoing Milligan Morgan hemorrhoidectomy;Secondary Objective: Secondary: to evaluate the influence of treatment in reducing pain intensity after evacuation, on proctology examination after surgery,on the comsumption of additional ``Rescue medication``(acetaminophen) from the 3rd to 14th day after the surgery and on time of return to work.;Primary end point(s): comparison between treatment group and placebo group in the percentage Responders and non-responders in relation to ``PAIN Daily`` reported on 4th day post-intervention. RESPONDER: patients with post operative pain intensity ≤ 30 mm (VAS value) and no consumption of rescue medication.—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026