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

Surgical Remove of Hemorrhoids Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02046772
• Other study ID #: HUPA-EC-01-2012
• Secondary ID: 2012-000110-11
• Status: Completed
• Phase: Phase 4
• First received: January 22, 2014
• Last updated: August 21, 2014
• Start date: March 2012
• Est. completion date: March 2014

Study information

• Verified date: August 2014
• Source: Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics CommitteeSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Description:

DESIGN OF THE TRIAL:

A multicentre, randomized, single-blind, with masked evaluationby third parties clinical trial.

The Clinical Pharmacology Unit will perform a permuted blocks randomization scheme for each of the two hospitals participating in the trial. The result of this randomization will be kept in this unit and will not be accessible to investigators. Investigators will receive a series of opaque sealed envelopes with a number corresponding to the order of entry of the patients into the trial. When the patient is in the operating room, investigators must open the envelope which contains the group of treatment assigned to that patient. The patient will not know in which intervention group is included. Investigator who performs the spinal puncture and investigator who collects the data and performs the evaluation will no be the same person. This will allow a blind evaluation.

OBJECTIVES:

Main objective:

To evaluate whether the addition of morphine chloride to a low dose solution of local intradural anaesthetic in patients undergoing hemorrhoids surgery produces an anaesthetic efficacy comparable to that produced by a standard dose of local intradural anaesthetic and an improvement of postoperative analgesic efficacy.

Secondary objectives:

• Earlier mobilization of the patient.

• Minor adverse effects.

• A shorter hospital stay of the patient.

TREATMENTS:

Two groups of treatment will be formed, experimental and comparator. The experimental group will receive 3mg of Bupivacaine with addition of 50 micrograms of Morphine Chloride.

The comparator group will receive 5 mg of Bupivacaine.

RESCUE TREATMENTS

If necessary before surgery, midazolam will be administered from 0.02 to 0.05 mg / kg intravenous (IV) depending on clinical response and after the patient is set in the surgical position, if necessary, an intravenous infusion of propofol will be administered at 0.5 - 2mg / kg / h. Sedative drugs with analgesic effects as opioids, ketamine, etc, will be avoided to not interfere with the main analgesic study assessment.

After surgery and during the hospitalization stay the rescue analgesia treatment will be administered only on demand. The rescue treatment allowed by protocol will be an intravenous administration of dexketoprofen up to 50 mg / 8 h and if insufficient, a rescue of 3 mg of morphine chloride will be administered. If morphine chloride is received, these patients will be recorded in the case report forms as inefficacy of the treatment. At home, after discharge, patients will receive rescue analgesia with capsules of dexketoprofen 25 mg / 8 h. (up to 75 mg a day).

SAMPLE SIZE:

60 patients ( 30 patients in the experimental group and 30 patients in the control group)

EFFICACY ASSESSMENT

Pain will be assessed using a visual analog scale (VAS from 0 to 10) at the beginning and end of surgery, at the arrival of resuscitation unit, after 10 and 30 minutes after arrival, during hospitalization stay out of the resuscitation unit and daily at home after discharge.

Doses required of rescue analgesia and hospitalization time will be recorded.

SAFETY ASSESSMENT

Basic monitoring as usual will be perfomed in the surgery room. Motor blockage will be assessed using the modified Bromage scale as follows: 1 = complete motor blocking, 2 = able to move feet only, 3 = patient move the feet and bend the knee, 4 = straight leg raises <30 ° or > 30 ° but not against resistance, 5 = lifts leg> 30 ° against resistance. This measure will be made after surgery in the surgery room and at the arrival and at one hour after resuscitation unit admission.

All the Adverse events will be reported.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhoids
• Surgical Remove of Hemorrhoids

Intervention

Drug:
• Bupivacaine low dose
A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural
• Bupivacaine standard dose
Single intradural standard dose of bupivacaine
• Morphine Chloride
A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural

Locations

Country	Name	City	State
Spain	Hospital Universitario Principe de Asturias	Alcala de Henares	Madrid
Spain	Hospital del Henares	Coslada	Madrid

Sponsors (3)

Lead Sponsor	Collaborator
Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias	Spanish Agency of Medicines, Spanish Health Ministry

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Greater and Earlier Mobilization Measured by Bromage Scale.	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.; Total Score in the Bromage Scale goes from 1 to 5, where: 1: complete motor blocking - 2: capable to move the feet - 3: moves the feet and bends the knee - 4: raise the leg straight more or less than 30 degrees but no against resistance - 5: raise the leg straight more than 30 degrees against resistance (no motor blocking)	During the first 24 hours after surgery and at the entry and exit of the resuscitation unit	Yes
Secondary	Number of Adverse Events	To assess if the experimental treatment causes less, equal or more adverse events than the comparator treatment.	Up to 72 hours from the intervention and the hopitalary stay and during the next 7 days after discharge	Yes
Secondary	Time of Hospitalization	To see if the hospitalization time is shortened or not by the experimental treatment.	Up to 72 hours after the intervention	Yes