The Effect of Preoperative Oral Pregabalin and Intraoperative Fentanyl on Postoperative Analgesia in Diagnostic Laparoscopic Gynecologic Surgery: a Comparative Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Changes in post-operative pain score at rest over time
研究概览
简要总结
Pregabalin is a structural analogue of gamma amino butyric acid (GABA). It binds to presynaptic alpha-2-delta subunit of voltage gated calcium channels in the brain and the spinal cord. Thus, it modulates the release of excitatory neurotransmitters, such as glutamate, norepinephrine, substance-P, and calcitonin gene related peptide. Also, it causes inhibitory modulation of overexcited neurons and restores them to a normal state.
Pre-emptive analgesia aims to reduce postoperative opioid consumption especially in ambulatory surgeries. Pregabalin (PGB) is an emerging drug in this field. Different doses of preoperative oral pregabalin (75, 150 and 300 mg) are described in the literature with a dose-response analgesic relationship and reduction of opioid use; however increasing the dose results in increasing the incidence of side effects mainly sedation and dizziness.
Perioperative use of opioids for analgesia may result in side effects; like nausea, vomiting, excessive sedation, respiratory depression, pruritus, and urinary retention.The concomitant use of opioids with pregabalin may result in excess sedation and somnolence, so, the use of opioids with pregabalin should be limited to patients with inadequate alternative options.
详细描述
Our study aims to compare the postoperative analgesic effect of pre-operative oral pregabalin (Study group), to the intraoperative intravenous fentanyl (Control group) in diagnostic laparoscopic gynecologic surgery.
Patienrs will be selected by simple randomization by computer generated system. Pregabalin 150 mg oral capsule and a placebo capsule will be available on the morning of operation.
Also, 2 syringes of 10 ml volumes will be prepared; the first contains normal saline and the second contains the fentanyl dose of 1 µg /kg calculated according to the patient's body weight and diluted to a 10 ml volume.
Patients will then be divided into 2 equal groups of 40 patients each:
Group P: Patients will receive oral pregabalin capsule (150 mg) 90 min before induction of anesthesia, and will receive a bolus injection of 10 ml saline at induction of anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •ASA physical status I
排除标准
- •Patients' refusal
- •use of sedatives, hypnotics, anti-psychotic or antidepressant drugs
- •history of drug/alcohol abuse
- •history of chronic pain
- •daily intake of analgesics
- •history of epilepsy
研究组 & 干预措施
Group Pregabalin
Patients will receive oral pregabalin capsule (150 mg) 90 min before induction of anesthesia, and will receive a bolus injection of 10 ml saline at induction of anesthesia
干预措施: Pregabalin 150mg (Drug)
Group Fentanyl
Patients will receive oral placebo capsule identical to the trial drug in size, shape and color, 90 min before induction of anesthesia and will receive a bolus injection of 10 ml of 1µg /kg fentanyl at induction of anesthesia
干预措施: Fentanyl 100 micrograms ampoule (Drug)
结局指标
主要结局
Changes in post-operative pain score at rest over time
时间窗: 1 hour
Intensity of pain will be monitored at 15 and 30min after arrival to the PACU, then 1h before discharge from the PACU. For analysis, pain severity will be categorized as absent (VAS=0), mild (VAS=1-3), moderate (VAS=4-7), severe (VAS=7-9), and very severe (VAS=10).
Changes in post-operative pain score on coughing over time
时间窗: 1 hour
Intensity of pain will be monitored at 15 and 30min after arrival to the PACU, then 1h before discharge from the PACU. For analysis, pain severity will be categorized as absent (VAS=0), mild (VAS=1-3), moderate (VAS=4-7), severe (VAS=7-9), and very severe (VAS=10).
次要结局
- Pre-operative level of patient sedation assessed by the sedation score(1 hour)
- Duration of surgery(2 hours)
- Duration of anesthesia(3 hours)
- mean values of systolic blood pressure (SBP)(4 hours)
- Intra-operative additional doses of fentanyl given(3 hours)
- Postoperative level of patient sedation(1 hour)
- Post-operative pain score(12 hours)
- Pethidine requirements(1 hour)
- sPO2(4 hours)
- changes in mean values of diastolic blood pressure (DBP)(4 hours)
- changes in mean values of mean blood pressure (MBP)(4 hours)
- mean values of heart rate (HR)(4 hours)
- total dose of pethidine given to the patient(12 hours)
研究者
Ghada M.Samir
Assistant Professor of Anesthesia, Intensive care and Pain Management
Ain Shams University