A comparative study between transdermal buprenorphine patch versus intravenous fentanyl for postoperative analgesia in patients undergoing major abdominal surgeries under general anaesthesia
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- visual analogue scale
研究概览
简要总结
Post operative pain is very common in major abdominal surgeries, and one of the major concerns for the patient undergoing major surgery. Pain in the first few days after surgery can lead to delayed ambulation, increase in cardiopulmonary and thrombotic morbidity as well the development of chronic pain.
Appropriate pain relief leads to shortened hospital stays, reduced hospital costs, increased patient satisfaction. Opioid is generally regarded as an important part of multimodal, perioperative analgesia, especially for moderate to severe pain. •Buprenorphine is a semisynthetic opioid derivative of thebaine, being a potent and safe analgesic (75-100 times greater than that of morphine) at 5-10% receptors occupancy, causing less respiratory depression. Time to attain minimum therapeutic concentration after transdermal patch is 21 hours. Fentanyl is a potent synthetic opioid similar to morphine, but produces analgesia to great extent. IV Fentanyl has an appropriate effectiveness in acute pain relief and suitable doses have comparable effects to morphine, with shorter onset of action being 30-60 mins, onset of action being 60 seconds.
Traditional and most common approach of post operative analgesia includes usage of opioid drug like morphine or fentanyl taken intravenously.
Transdermal opioids are newer modality in use for the control of postoperative pain, because of its non invasiveness, longer duration of action, sustained blood levels and with minimal side effects
There fore, the need of this study is to compare between traditional and standard approach- Intravenous fentanyl versus newer modality transdermal buprenorphine in the management of post operative pain, as there are very few studies quoted about them.
our study is randomized study conducted in bangalore medical college and research institute
conducted in 30 patients, 15 patients receiving transdermal buprenorphine as post operative analgesia and other 15 receiving intravenous fentanyl as postoperative analgesia.
postoperatively pain will be asssessed by visual analogue scale, ramsay sedation score, hemodynamic parameters.
adverse effects caused by both the groups noted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with weight 40-80kgs.
- •Patients scheduled for open elective intraperitoneal abdominal surgeries under general anaesthesia Patients giving informed written consent.
- •Patients belonging to ASA I, II.
排除标准
- •1.Patients who refused to give informed written consent.
- •2.Patients with ASA physical status III or more.
- •3.Patients with known cardiac and pulmonary complications.
- •4.Patients with known allergy to opioids.
- •5.Patients with mental illness.
- •6.Pregnants and breastfeeding females.
- •Surgeries of duration > 3 hours.
- •Surgeries including surgical incision extended 5 cm above the umbilicus.
结局指标
主要结局
visual analogue scale
时间窗: Post operative day 1 to day 3
次要结局
- ramsay sedation scale(hemodynamic parameters)