Randomized, Controlled, Double Blind, to Evaluate the Postpartum Analgesia With Epidural Morphine: Analgesic Effect of Two Different Doses Compared to Placebo
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      This study aims to assess the analgesic effect of two different doses of epidural morphine
      for postpartum analgesia management. Previous studies have shown that conventional management
      of postpartum pain (acetaminophen, NSAIDs) is insufficient, in the investigators country is
      wasted using the epidural catheter is placed as part of the analgesic management of pregnant
      women in labor.
    

Detailed description: 
      The intervention is the epidural administration of morphine in two doses 2mg and 3mg
      different vs placebo 1 hour after delivery care maternal vaginal in patients who received
      epidural analgesia in labor, in order to evaluate the analgesic effectiveness post operations
      of the different doses vs placebo.

      In the analysis to determine whether the proposed levels are effective for postpartum pain
      control was carried out by determining the differences between experimental groups and
      control group, and in examining the statistical significance of the differences found by
      applying the relevant tests according to whether the variable is normally distributed or not.

      The main variables analyzed were:

      rating of pain intensity, number of analgesics required required dose of analgesics used to
      achieve adequate control pain, number of pain episodes and percentage of patients free of
      these episodes, duration of action of the dose used.

      Similar analysis was determined by the incidence of side effects, in particular those
      described in classic form, pruritus, nausea and vomiting, urinary retention, and respiratory
      depression

      Were classified into three groups: two experimental and one control group.

      Experimental Group 1 will receive 10 ml of solution prepared as follows:

      2 mg of morphine diluted in 0.9% normal saline

      Experimental Group 2 will receive 10 ml of solution prepared as follows:

      3 mg of morphine diluted in 0.9% normal saline

      The control group will receive 10 ml of normal saline (SSN).

      The randomization codes were kept in a sealed envelope so individual, and the envelopes were
      guarded and uncovered after a eligible to participate in the study agreed to be included and
      signed the informed consent.

      Anesthesia Technique for the Study

      In ASA II patients in labor who were initiates of labor analgesia with epidural catheter has
      been placed ideally at the level of L3-L4 (Tuohy catheter conventional number 18, introduced
      by loss of resistance technique) .

      The patients were started a conventional dose of analgesia with bupivacaine 0.5% + fentanyl
      100mcg 10mg 10cc carried in a bolus. Administered bupivacaine + 10 mg bolus of fentanyl
      100mcg as needed to strengthen the epidural analgesia

      or Infusion Bupivacaine 0.125% + Fentanyl 100mcg%

      In a 10cc bolus then 8-16CC hours

      In patients 1 hour after having her expulsive morphine were previously applied in laboratory
      and packaged in disregard of the anesthesiologist applied morphine 2mg - 3mg or saline
      placebo.

      The dose will be applied 1 hour after birth in search of having no residual analgesic effect
      of local anesthetic and opioid epidural analgesia initially applied.

      All patients will be managed with conventional analgesia performed in the institution
      acetaminophen 1 g every 6 hours VO

      If additional merit the first choice analgesic diclofenac 75mg IM is, if no answer will apply
      a dose of 100mg tramadol or morphine IV in titrated only if warranted more analgesia.

      For all patients will have availability of naloxone in case of respiratory depression.

      Patients will be observed for 24 hours with monitoring the consumption of other analgesics,
      pain visual analog scale, which is evaluated at the time of the application of morphine, 2h,
      4h, 6h 12h and 24h after application of morphine. Also evaluated variables such as
      development of pruritus, nausea, vomiting, urinary retention and assessment of respiratory
      rate.
    

Intervention name(s): Morphine; saline solution; Morphine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): morphine 3 mg; 4 cc of saline solution in epidural cateter in postpartum; morphine 2 mg for epidural cateter in postpartum
Other intervention name(s): Random code numbers; Random code numbers; Random code numbers
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Epidural opioid; Morphine; Postpartum pain; Analgesia; Perineorraphy