Comparison of analgesic efficacy of ultrasound guided modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) VS oblique subcostal transversus abdominis plane block(OSTAP) in laproscopic cholecystectomy -A randomized controlled trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare the 24 hour cumulative post-operative analgesic consumption [Tramadol] between the M-TAPA block, and the OSTAP block after laparascopic cholecystectomy .
研究概览
简要总结
Laparoscopic cholecystectomy leads to somatic pain from the supraumbilical abdominal area and also visceral pain due to pneumoperitoneum and surgical manipulation.Pain managment in these patients is very important for enhanced recovery after surgery.Ultrasoundguidance and anatomic studies have led to the description of many new interfascial plane blocks.One of the most commonly used blocks is oblique transverse abdominisplane block[OSTAP] to relief post operative pain relief in laparoscopic abdominal surgeries.The thoracoabdominalnerves block through perichondrial approach[M-TAPA] is one of the newer blocks that is used nowadays for postoperative analgesia in laparoscopic abdominal surgeries. Early studies seem to indicate that M-TAPA hasadvantage over OSTAP.
We will be conducting a double blinded, randomized control trial to compare the analgesic efficacy of ultrasound guided modified thoracoabdominal nerve block through perichondrial approach versus oblique subcostaltransversus abdominis plane block for laparoscopic cholecystectomy.
Total of 60 patients will be randomly allocated into two equal groups of 30 patients each.The M-TAPA or OSTAP Blocks will be administered following general anesthesia with endotracheal intubation by the standard institutional protocol.
We will note the 24 hour post-operative analgesic consumption [Tramadol ] ; the time of first rescue analgesic administration, and the NRS pain scale at 30 min ; 1 hour ; 2 hour ; 4 hour ; 8 hour and 24 hour will be noted .QoR-15 questionnaire scores both before and after the operation will recorded.Comparison of thoracoabdominal areas(T3-L1) with sensory block 2hours following surgery will be noted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged 18 -75 years old, with American Society of Anaesthesiologists Physical Status grades [ASA] 1-3, scheduled for elective laparascopic cholecystectomy.
排除标准
- •Known allergy or intolerance to injection Ropivacaine.Infection at the injection site of the block.Opioid consumption in last 24 hours.
- •Coagulopathy.Known case of Psychiatric illness.Body mass index (BMI) ≥ 40kg /m2.
结局指标
主要结局
To compare the 24 hour cumulative post-operative analgesic consumption [Tramadol] between the M-TAPA block, and the OSTAP block after laparascopic cholecystectomy .
时间窗: Comparison of total tramadol consumption in 24hours.
次要结局
- NRS pain score(30min 1 hour 2 hour 4 hour 8hour 24 hour)
- Time to first rescue analgesia(Time taken to give first rescue analgesia)
- Comparison of QoR - 15 scale between the two groups(24 hours post operative)
- Comparison of thoracoabdominal areas with sensory block(T3 -L1)
研究者
Rahul Katyal
Northern Railway Central Hospital