A Comparison Between Pregabalin and Gabapentin as Adjuvants to Opioids in Elective Lumber Micro Discectomy to Control Postoperative Pain. (A Prospective Randomized Controlled Study)
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- time to first rescue analgesia during the first postoperative 24 hours.
研究概览
简要总结
Pregabalin and gabapentin are both GABA analogue and their mechanism of action is not fully understood. Both drugs when given as a pre-emptive analgesia for spinal surgery were found to reduce intra-and postoperative opioid requirements.
Preoperative intramuscular injection of morphine could reduce the patients' pain during the percutaneous transformational endoscopic discectomy "PTED" surgery and improve the patients' satisfaction without affecting the surgical outcome. The efficacy of adding pregabalin or gabapentin to preoperative intramuscular morphine is not yet investigated.
The current study aims to compare the analgesic effect of both drugs when given preoperatively with intramuscular morphine.
详细描述
Preoperative assessment will be conducted on the patients that will be enrolled in this study including history taking, Physical examination, and laboratory investigations and radiological investigations; according to the medical condition of the patients. All patients must fulfill the inclusion criteria then the patients are consented to be included in the study & informed about the required fasting hours.
Informed consent will be obtained from the entire patient enrolled in this study on the day before surgery. VAS score will be explained to all the patients' Visual analogue scale to measure post-operative pain.
VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end.
The patient marks on the line the point that they feel represents their perception of their current state. On the day of surgery, study drug was given orally 1 hour before the time of induction of anesthesia.
In the operation theatre, baseline heart rate, oxygen saturation, and mean arterial blood pressure were recorded. After insertion of a wide bore cannula, and premeditations will be given including anxiolytics e.g. midazolam (70-80mcg/kg) not to exceed >5mg and Ondansteron (4mg)
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA I and ASA II
- •Elective Lumber micro discectomy.
- •Time of operation not exceeding 2hours.
排除标准
- •Patients' refusal
- •Age < 20 years or > 60 years
- •ASA III to ASA IV
- •Contraindications to Opioids e.g., Allergy, Bronchial asthma.
- •Contraindication to Pregabalin or Gabapentin e.g. Allergy
- •Psychological or mental disorders.
- •Disturbance of Conscious level.
- •Uncooperative patients.
- •Patients with impaired renal function or creatinine clearance less than 50ml/min
研究组 & 干预措施
Group P
The patients in this group will receive 150 mg pregabalin tablets P.O 1 hours before surgery then after half hour morphine 0.1 mg/kg will be administered intramuscularly.
干预措施: Pregabalin 150mg gabapentin 400mg (Drug)
Group G
The patients in this group will receive 400 mg Gababentin4 tablets P.O 1 hours before surgery then after half hour morphine 0.1 mg/kg will be administered intramuscularly.
干预措施: Pregabalin 150mg gabapentin 400mg (Drug)
Group C
The patients in this group will receive vitamin B12 (100µg) as placebo tablets P.O hours before surgery then after half hour morphine 0.1 mg/kg will be administered intramuscularly.
干预措施: Pregabalin 150mg gabapentin 400mg (Drug)
结局指标
主要结局
time to first rescue analgesia during the first postoperative 24 hours.
时间窗: 24 hours
call for analgesia
次要结局
- pain score(24 hours post operative)