Oral Pregabalin as Preemptive Analgesia in Abdominal Hysterectomy
Condition: Pain, Postoperative; Analgesia; Gabapentin Adverse Reaction; Opioid Abuse
MeSH terms: Agnosia; Pain, Postoperative; Opioid-Related Disorders
Intervention: Pregabalin 300mg; Placebo
Intervention description: Group P1 will receive a 300 mg tablet of pregabalin, 02h before the surgical procedure; Group P0 will receive a placebo tablet, 02h before the surgical procedure
Intervention MeSH terms: Pregabalin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 58.0
Sex: Female
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: postoperative pain; multimodal analgesia; pregabalin; preemptive analgesia; abdominal hysterectomy; gabapentins

Summary:

      Postoperative pain affects 80% of surgical patients and is one of the main negative symptoms
      resulting from surgery. It impairs the recovery of patient since it is related to chronic
      pain, nausea and vomiting and longer hospital stay, generating higher cost to the health
      system. Thus, the use of new methods to control postoperative pain is recommended and
      multimodal analgesia, an opioid-sparing strategies, has been widely used by several
      researchers. Studies show that gabapentins have beneficial effects on postoperative pain
      control when used as pre-anesthetic medication, also showing a reduction in opioid
      consumption, with few adverse effects. Among gynecological surgeries, abdominal hysterectomy
      is one of the procedures that generates the highest degree of acute postoperative pain. Thus,
      the aim of the present study is to investigate the effect of oral pregabalin (300 mg) two
      hours before abdominal hysterectomy procedures on postoperative pain. This study is a
      randomized, double-blind, placebo controlled clinical trial. Patients submitted to abdominal
      hysterectomy for benign pathologies will be selected and divided into two groups: the placebo
      controlled group (P0) and the pregabalin 300 mg group (P1). Group P0 will receive a placebo
      tablet one hour before the procedure, while group P1 will receive a 300 mg tablet of
      pregabalin identical to the placebo tablet. The reduction of postoperative pain and the best
      quality of patient recovery will be evaluated using the Visual Analogue Pain Scale (VAS) and
      the McGill Pain Questionnaire. Also, it will be evaluated the consumption of opioids as a
      rescue analgesic medication and the presence of adverse effects such as nausea and vomiting.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients who will undergo elective abdominal hysterectomy surgery due to benign
             pathologies;

          2. Be classified as physical status by the Society of Anesthesiologists (ASA) as ASA I
             (healthy individual) or ASA II (patient with mild and controlled systemic disease);

        Exclusion Criteria:

          1. Allergy or intolerance previously known to pregabalin or opioids;

          2. Patients with chronic pain or fibromyalgia;

          3. Patients on chronic opioid use;

          4. Carriers of malignant neoplasms;

          5. Pregnant women;

          6. People with active uncontrolled cardiovascular disease;

          7. Patients with kidney and / or liver disease;

          8. Patients who have spinal deformities that make spinal anesthesia impossible;

          9. Presence of coagulation disorders or anticoagulant therapy that cannot be suspended
             for surgery;

         10. Presence of active sepsis.