Ultrasound guided bilateral retro laminar block for post operative analgesia in patients undergoing total laproscopic hysterectomy: A randomised controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To compare the post operative pain score using numerical rating scale ( NRS ) following ultrasound guided bilateral retro laminar block in patients undergoing total laparoscopic hysterectomy ( 0 = no pain , 10 = worst pain imaginable)
研究概览
简要总结
Total laparoscopic hysterectomy is widely performed for various benign gynaecological conditions, although minimally invasive, it can result in significant post operative pain. Current pain management practices often rely heavily on opioids, which are associated with adverse effects, regional anaesthesia techniques offer an effective, opioid sparing alternative. The ultrasound guided bilateral retro laminar block has demonstrated promising results in thoracic and upper abdominal surgeries, however, evidence on its efficacy in lower abdominal and pelvic surgeries is sparse. This study aims to address this lacuna in literature.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •ASA PS I-II, scheduled for total laparoscopic hysterectomy under general anaesthesia.
排除标准
- •Patient refusal, allergy to local anaesthetic, cardiac/hepatic/renal dysfunction, BMI more than 30 kg per meter square, infection at site of block, coagulopathy, chronic opioid use, altered mental status.
结局指标
主要结局
To compare the post operative pain score using numerical rating scale ( NRS ) following ultrasound guided bilateral retro laminar block in patients undergoing total laparoscopic hysterectomy ( 0 = no pain , 10 = worst pain imaginable)
时间窗: 1 hour, 2 hours, 4 hours, 8 hours, 12 hours and 24 hours postoperatively
次要结局
- Time to first rescue analgesia.(Whenever NRS score is greater than 4, postoperatively for the first 24 hours.)
- Total intra operative opioid requirement.(During the surgery, if heart rate and mean arterial pressure increases more than 20% of baseline values.)
- Total requirement of rescue analgesia.(First 24 hours postoperatively.)
- To compare post operative recovery using Quality of Recovery-15 ( QoR-15) questionnaire.(At first post operative day after 24 hours of anesthesia.)
- Time to ambulation.(0 to 48 hours.)
- Complications or side effects(0 to 48 hours)
研究者
Dr Akshat Chaturvedi
AIIMS, New Delhi