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Clinical trial to assess the efficacy and safety of different analgesic strategies in the treatment of pain in surgery of piles.

Evaluation of the analgesic efficacy of morphine chloride added to a solution of spinal low dose of local anesthetic as compared to standard doses of spinal local anesthetic alone in patients undergoing haemorrhoidectomy: single blind controlled clinical trial with masked evaluation by third parties.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-000110-11-ES
Enrollment
Unknown
Registered
2012-03-05
Start date
2012-05-07
Completion date
Unknown
Last updated
2012-05-23

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

Conditions

The combined use with local anesthetics may allow for a reduction in the dose of the latter, without impairment of intraoperatory anesthesia, improving the early mobility of patients and minimizing the adverse effects. MedDRA version: 14.1 Level: LLT Classification code 10036236 Term: Postoperative pain relief System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Product Name: Bupivacaine hydrochloride Pharmaceutical Form: Solution for injection INN or Proposed INN: BUPIVACAINE HYDROCHLORIDE CAS Number: 18010-40-7 Concentration unit: mg milligram(s) Concentrat

Sponsors

Fundación para la Investigación Biomédica del Hospital Universitario Príncipe de Asturias
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -Patients undergoing haemorrhoidectomy -Age: 18-65 years old -Males and females. -ASA (American Society of Anesthesiology Classification) I to III. -Spinal bolck indication -Signed Informed Consent 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 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -Patients with allergy to study drugs. -Patients with any contraindication to performing a spinal technique. -Patients with previous neurological disorders.

Design outcomes

Primary

MeasureTime frame
Timepoint(s) of evaluation of this end point: In the resuscitation unit, 10 and 30 minutes after the surgery, 24 hours after the surgery and daily until 7 days from surgery.;Primary end point(s): Analgesic effect measured by a visual analgesic scale;Main Objective: To assess the analgesic efficacy of morphine chloride added to intradural local anesthetics at low doses in patients undergoing haemorrhoidectomy as compared to standard doses of intradural local anesthetics.;Secondary Objective: Evaluate if the morphine chloride added to intradural local anesthetic at low doses in patients undergoing haemorrhoidectomy can produce: -Early mobility of patients -Less adverse events -Shortening the patient's hospital stay—

Secondary

MeasureTime frame
Secondary end point(s): a) Total of analgesic doses taken b) Degree of motor impairment c) Adverse events;Timepoint(s) of evaluation of this end point: a) 7 days from surgery b)At the arrival to the resuscitation unit c)Anytime over the study period—

Countries

Spain

Contacts

Public ContactClinical Trials Information

Fundación para la Investigación Biomédica del Hospital Universitario Príncipe de Asturias

fundacion.hupa@gmail.com00349188781002605

Outcome results

None listed

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