Oral Pregabalin as Preemptive Analgesia in Abdominal Hysterectomy

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.

Conditions

• Pain, Postoperative
• Analgesia
• Gabapentin Adverse Reaction
• Opioid Abuse

Interventions

DRUG

Pregabalin 300mg

Group P1 will receive a 300 mg tablet of pregabalin, 02h before the surgical procedure

OTHER

Placebo

Group P0 will receive a placebo tablet, 02h before the surgical procedure

Sponsors & Collaborators

• Universidade Federal de Alfenas

  lead OTHER

Principal Investigators

• Larissa H Torres, PhD · Universidade Federal de Alfenas

• Fabrício G Silva, BSc · Santa Casa de Alfenas

• Carlos M de Barros, BSc · Universidade Federal de Alfenas

• Marcia H Podestá, PhD · Universidade Federal de Alfenas

• Carla S Ceron, PhD · Universidade Federal de Alfenas

• Thayná C Silva, BSc · Santa Casa de Alfenas

• Denismar A Nogueira, PhD · Universidade Federal de Alfenas

• Tiago M Reis, PhD · Universidade Federal de Alfenas

• Milena C Espósito, PhD · Universidade Federal de Alfenas

• Danielle A Oliveira, BSc · Universidade Federal de Alfenas

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-09-02

Primary Completion

2020-09-09

Completion

2020-09-30

Countries

• Brazil

Study Locations