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

Conditions: MedDRA version: 14.1Level: LLTClassification code 10036236Term: Postoperative pain reliefSystem Organ Class: 10042613 - Surgical and medical procedures
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.
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2012-000110-11-ES

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

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:<br>-Early mobility of patients <br>-Less adverse events<br>-Shortening the patient's hospital stay

Secondary Outcome Measures

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