Oral Pregabalin as Preemptive Analgesia in Abdominal Hysterectomy

• Status: Terminated
• Trial end date: 2020-09-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universidade Federal de Alfenas
• Treatments: Pregabalin

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.