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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

NCT02046772 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2016-08-15

Study results available
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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.

Conditions

  • Surgical Remove of Hemorrhoids

Interventions

DRUG

Bupivacaine low dose

A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural

DRUG

Bupivacaine standard dose

Single intradural standard dose of bupivacaine

DRUG

Morphine Chloride

A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural

Sponsors & Collaborators

  • Spanish Agency of Medicines and Health Products

    collaborator OTHER_GOV

  • Spanish Health Ministry

    collaborator UNKNOWN

  • Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias

    lead OTHER

Principal Investigators

  • Manuel Ruiz Castro, MD, PhD · Hospital Universitario Principe de Asturias

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02046772 on ClinicalTrials.gov