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