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
Condition: Surgical Remove of Hemorrhoids
MeSH terms: Hemorrhoids
Study type: Interventional
Phase: Phase 4

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.
    

Detailed 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:

      66 patients ( 33 patients in the experimental group and 33 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.
    

Intervention name(s): Bupivacaine low dose; Bupivacaine standard dose; Morphine Chloride
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural; Single intradural standard dose of bupivacaine; A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural
Intervention MeSH terms: Morphine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: hemorrhoidectomy; analgesia; anaesthetic; bupivacaine; morphine chloride