Safety and Efficacy of the Addition of Morphine Chloride to a Low Dose of Bupivacaine as Intradural Anaesthetic for the Removal Surgery of the Hemorrhoids

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

A single blind, randomized, with blinded evaluation by third parties clinical trial is carried out to assess the analgesic efficay of the addition of morphine chloride to a low dose solution of spinal local anaesthetic compared to a standard dose spinal anaesthetic in the haemorrhoid surgery.

The objective of this clinical trial is to assess if the experimental treatment is as efficacy as the standard treatment in the anesthetic and analgesic effects with less side effects, greater and earlier mobility after surgery and shortened the hospitalization.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias
• Collaborators: Spanish Agency of Medicines; Spanish Agency of Medicines and Health Products; Spanish Health Ministry
• Treatments: Anesthetics; Bupivacaine; Morphine; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Patients undergoing hemorrhoidectomy.

• Age between 18 and 64.

• Both gender

• ASA I to III.

• With indication for spinal block.

• People capable to grant the informed consent.

Exclusion Criteria:

• Patients with allergies to the study drugs.

• Patients with any contraindication for performing a spinal technique (coagulation disorders, fever, intracraneal hypertension, abscess in the puncture site, etc..).

• Patients with previous neurological disorders.

• Pregnant women.

• Women who may be pregnant and do not have a negative pregnancy test.

• Breastfeeding women.

• Patients with uncapable to give informed consent.