Use of Oral Pregabalin as Preemptive Analgesia in Abdominal Hysterectomy: Evaluation of Postoperative Pain and Opioid Consumption
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Postoperative Pain in Rest Assessed 24 Hours After Abdominal Hysterectomy Surgery Using the Visual Analog Scale (VAS)
研究概览
简要总结
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.
详细描述
The sample population of this study is 102 female patients (50 already included in the study), who have undergone abdominal hysterectomy surgery for benign conditions, with or without joint oophorectomy / salpingectomy. The patients received spinal anesthesia, at hospital "Santa Casa de Alfenas" - Minas Gerais / Brazil ("Casa de Caridade Nossa Senhora do Perpétuo Socorro"). All surgeries were performed by the same team of surgeons.
All patients were evaluated and followed from the preoperative period, up to 24 hours postoperatively, passing through the intraoperative period. During all stages, patients were assisted by a properly trained multi-professional team, consisting of a doctor, nurse and nursing technician.
For the patient to be included in the study, she must have understood and agreed with the informed consent form that was explained in detail to all possible candidates in the preoperative period.
This is a double blind randomized study. The patients were randomly allocated to 02 groups, in which Group 1 received medication A (designated in the study as medication 1), whereas Group 2 received medication B (designated in the study as medication 2).
Study participants and researchers were blinded as to the use of drug / placebo to avoid measurement bias. To carry out the blinding process, an external researcher was assigned to randomize the groups and prepare the pills in opaque and closed envelopes characterized only by a control identification (A or B), which is known only to this researcher. Patients in both groups received identical sealed envelopes, 02h before the start of the anesthetic procedure, only identified as medication A or B, which contained two pills in each envelope. A second researcher is responsible for collecting data and monitoring the patient from the intraoperative period up to 24 hours after discharge from the post-anesthetic recovery room (PARR).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who will undergo elective abdominal hysterectomy surgery due to benign pathologies;
- •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);
排除标准
- •Allergy or intolerance previously known to pregabalin or opioids;
- •Patients with chronic pain or fibromyalgia;
- •Patients on chronic opioid use;
- •Carriers of malignant neoplasms;
- •Pregnant women;
- •People with active uncontrolled cardiovascular disease;
- •Patients with kidney and / or liver disease;
- •Patients who have spinal deformities that make spinal anesthesia impossible;
- •Presence of coagulation disorders or anticoagulant therapy that cannot be suspended for surgery;
- •Presence of active sepsis.
研究组 & 干预措施
Group P(0) - Placebo
Patients were randomly allocated to Group P(0) - Placebo by a double blind randomized study. Group P(0) received two placebo tablets as medication, 02h before the start of the anesthesic-surgical procedure in identical sealed envelops, only identified as medication A or B
干预措施: Placebo (Other)
Group P(1) - Pregabalin 300mg
Patients were randomly allocated to Group P(1) - Pregabalin 300mg by a double blind randomized study. Group P(1) received two tablets of pregabalin 150mg, 02h before the start of the anesthesic-surgical procedure in identical sealed envelops, only identified as medication A or B
干预措施: Pregabalin 300mg (Drug)
结局指标
主要结局
Postoperative Pain in Rest Assessed 24 Hours After Abdominal Hysterectomy Surgery Using the Visual Analog Scale (VAS)
时间窗: End of the first postoperative day of abdominal hysterectomy surgery (24 hours after the end of surgery)
Postoperative pain assessment, 24 hours after abdominal hysterectomy surgery, in patients who used a single dose of pregabalin 300mg or placebo as preemptive analgesia, using the visual analog scale (VAS) consisting of a 10 cm (cm) line ) graduated in natural number intervals, starting at 0 (zero) until reaching 10 (ten), associated with the numbers, drawings related to the pain presented by the patient at the moment, in which the absence of pain (0 ) there is a happy face, and as the numerical value increases, the drawn face will represent the intensity of pain, up to the value of 10, where a face with crying characteristics is found, indicating greater pain.
Postoperative Pain Assessed 24 Hours After Abdominal Hysterectomy Surgery, Using the McGill Pain Questionnaire
时间窗: End of the first postoperative day of abdominal hysterectomy surgery (24 hours after the end of surgery)
Postoperative pain assessment, 24 hours after abdominal hysterectomy surgery, in patients who used a single 300mg dose of pregabalin or placebo as preemptive analgesia, using the McGill pain questionnaire, which consists of 20 word groups , and each group can contain from 2 to 6 descriptive words, these descriptors are placed in an increasing order of magnitude in relation to the intensity. The left of each word has a numerical value in an attempt to represent the intensity of the descriptor. For the analysis of the answers, the total number of words chosen in each subgroup by the patient was used to qualify his pain, the minimum value being equal to 0 (zero), if the patient chose not to choose any descriptor, and the maximum value would be 20, as the patient can choose only one descriptor for each subgroup. The quantitative pain index was also evaluated, which represents the sum of the values of each descriptor chosen by the patient, with a minimum value of 0 and a maximum of 78.
Postoperative Pain in Active Movement Assessed 24 Hours After Abdominal Hysterectomy Surgery Using the Visual Analog Scale (VAS)
时间窗: End of the first postoperative day of abdominal hysterectomy surgery (24 hours after the end of surgery)
Postoperative pain assessment, 24 hours after abdominal hysterectomy surgery, in patients who used a single dose of pregabalin 300mg or placebo as preemptive analgesia, using the visual analog scale (VAS) consisting of a 10 cm (cm) line ) graduated in natural number intervals, starting at 0 (zero) until reaching 10 (ten), associated with the numbers, drawings related to the pain presented by the patient at the moment, in which the absence of pain (0 ) there is a happy face, and as the numerical value increases, the drawn face will represent the intensity of pain, up to the value of 10, where a face with crying characteristics is found, indicating greater pain.
次要结局
- Time Required for the Use of the First Dose of Opioid as an Analgesic Rescue in the Postoperative Period(End of the first postoperative day of abdominal hysterectomy surgery (24 hours after the end of surgery))
- Number of Participants With Dizziness Between the Intervention and Control Groups(End of the first postoperative day of abdominal hysterectomy surgery (24 hours after the end of surgery) and also immediately in the post-anesthetic recovery room)
- Number of Doses of Opioids Used as Analgesic Rescue in the Postoperative Period(End of the first postoperative day of abdominal hysterectomy surgery (24 hours after the end of surgery))
研究者
Larissa Helena Lobo Torres Pacheco
Principal Investigator
Universidade Federal de Alfenas