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 | Completed Phase 4 Results

• 2 other identifiers: HUPA-EC-01-20122012-000110-11
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

hemorrhoidectomy; analgesia; anaesthetic; bupivacaine; morphine chloride

Outcome Measures

Primary Outcomes (2)

• Measurement of Time to Start the Anaesthetic Effect

  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.

  First 20 minutes between administration and beginning of surgery

• Measurement of the Analgesic Effect After Surgery by VAS From 0 to 10, Where 0 is no Pain and 10 is the Worst Pain Imaginable.

  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.

  Up to 72 hours from the end of the surgery in the hospital stay and during the next 7 days at home, after discharge

Secondary Outcomes (3)

• Greater and Earlier Mobilization Measured by Bromage Scale.

  During the first 24 hours after surgery and at the entry and exit of the resuscitation unit

• Number of Adverse Events

  Up to 72 hours from the intervention and the hopitalary stay and during the next 7 days after discharge

• Time of Hospitalization

  Up to 72 hours after the intervention

Study Arms (2)

Bupivacaine + Morphine Chloride

EXPERIMENTAL

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; Drug: Morphine Chloride

Bupivacaine standard dose

ACTIVE COMPARATOR

People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine

Drug: Bupivacaine standard dose

Interventions

Bupivacaine low dose DRUG

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

Bupivacaine + Morphine Chloride

Bupivacaine standard dose DRUG

Single intradural standard dose of bupivacaine

Bupivacaine standard dose

Morphine Chloride DRUG

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

Bupivacaine + Morphine Chloride

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias: lead
• Spanish Agency of Medicines and Health Products: collaborator
• Spanish Health Ministry: collaborator

Study Sites (2)

Hospital Universitario Principe de Asturias

Alcalá de Henares, Madrid, 28805, Spain

Location

Hospital del Henares

Coslada, Madrid, 28822, Spain

Location

MeSH Terms

Conditions

Agnosia

Interventions

Bupivacaine; Morphine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Antonio Rodríguez Miguel
• Organization: Hospital Universitario Príncipe de Asturias

antonio.hupa@gmail.com

+34 91 887 81 00

Study Officials

• Manuel Ruiz Castro, MD, PhD

  Hospital Universitario Principe de Asturias

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2014
• First Posted: January 28, 2014
• Study Start: March 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: August 15, 2016
• Results First Posted: September 1, 2014

Record last verified: 2014-08

Locations

ES (2)