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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias
Sponsor:
Collaborators:
Spanish Agency of Medicines
Spanish Health Ministry
Information provided by (Responsible Party):
Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias
ClinicalTrials.gov Identifier:
NCT02046772
First received: January 22, 2014
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Surgical Remove of Hemorrhoids
Drug: Bupivacaine low dose
Drug: Bupivacaine standard dose
Drug: Morphine Chloride
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Assessment of the Analgesic Efficacy of Morphine Chloride in Addition to a Low Dose Solution of Spinal Anaesthetic in Hemorrhoidectomy Compared to a Standard Dose of Spinal Local Anaesthetic. Simple Blind, Randomized, With Blinded Evaluation by Third Parties Clinical Trial.

Resource links provided by NLM:


Further study details as provided by Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias:

Primary Outcome Measures:
  • Measurement of time to start the anaesthetic effect [ Time Frame: First 20 minutes between administration and beginning of surgery ] [ Designated as safety issue: No ]
    To compare whether the addition of morphine chloride to a low dose intradural solution of the local anaesthetic bupivacaine is as effective as an administration of a single dose of bupivacaine.

  • Measurement of the analgesic effect after surgery by VAS (from 0 to 10) [ Time Frame: Up to 72 hours from the end of the surgery in the hospital stay and during the next 7 days at home, after discharge ] [ Designated as safety issue: No ]
    To compare whether the addition of morphine chloride to a low dose solution of bupivacaine and improves the analgesic treatment than a single administration of bupivacaine.


Secondary Outcome Measures:
  • Greater and earlier mobilization measured by Bromage scale [ Time Frame: During the first 24 hours after surgery and at the entry and exit of the resuscitation unit ] [ Designated as safety issue: Yes ]
    To assess whether the administration of morphine chloride in addition to a low dose solution of local intradural anaesthetic (bupivacaine) improves the mobilization of the patients after surgery more than the single intradural administration of bupivacaine.

  • Number of adverse events [ Time Frame: Up to 72 hours from the intervention and the hopitalary stay and during the next 7 days after discharge ] [ Designated as safety issue: Yes ]
    To assess if the experimental treatment causes less, equal or more adverse events than the comparator treatment.

  • Time of hospitalization [ Time Frame: Up to 72 hours after the intervention ] [ Designated as safety issue: Yes ]
    To see if the hospitalization time is shortened or not by the experimental treatment.


Estimated Enrollment: 60
Study Start Date: March 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bupivacaine + Morphine Chloride
People in this arm will receive treatment with morphine chloride in addition to a low dose solution of the local intradural anaesthetic bupivacaine.
Drug: Bupivacaine low dose
A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural
Drug: Morphine Chloride
A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural
Active Comparator: Bupivacaine standard dose
People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine
Drug: Bupivacaine standard dose
Single intradural standard dose of bupivacaine

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02046772

Contacts
Contact: Manuel Ruiz Castro, MD, PhD +34 91 887 81 00 mruizc@hotmail.com
Contact: Antonio Rodriguez Miguel, PharmD +34 81 887 81 00 ext 2610 antonio.hupa@gmail.com

Locations
Spain
Hospital Universitario Principe de Asturias Recruiting
Alcala de Henares, Madrid, Spain, 28805
Contact: Manuel Ruiz Castro, MD, PhD    +34 91 887 81 00    mruizc@hotmail.com   
Contact: Antonio Rodriguez Miguel, PharmD    +34 91 887 81 00 ext 2610    antonio.hupa@gmail.com   
Principal Investigator: Manuel Ruiz Castro, MD, PhD         
Hospital del Henares Recruiting
Coslada, Madrid, Spain, 28822
Contact: Marta San Jose Santos, MD    +34 619 34 22 73    msanjosesantos@yahoo.es   
Contact: Antonio Rodriguez Miguel, PharmD    +34 91 887 81 00 ext 2610    antonio.hupa@gmail.com   
Principal Investigator: Marta San Jose Santos, MD         
Sponsors and Collaborators
Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias
Spanish Agency of Medicines
Spanish Health Ministry
Investigators
Principal Investigator: Manuel Ruiz Castro, MD, PhD Hospital Universitario Principe de Asturias
  More Information

No publications provided

Responsible Party: Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias
ClinicalTrials.gov Identifier: NCT02046772     History of Changes
Other Study ID Numbers: HUPA-EC-01-2012, 2012-000110-11
Study First Received: January 22, 2014
Last Updated: January 29, 2014
Health Authority: Spain: Ethics Committee
Spain: Spanish Agency of Medicines

Keywords provided by Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias:
hemorrhoidectomy
analgesia
anaesthetic
bupivacaine
morphine chloride

Additional relevant MeSH terms:
Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Anesthetics
Bupivacaine
Morphine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics

ClinicalTrials.gov processed this record on July 31, 2014