Comparision of thoracic epidural analgesia and ultrasound guided erector spinae plane block for post-operative pain control following laparoscopic cholecystectomy :A RANDOMIZED CLINICAL TRIAL
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 1.Duration of analgesia(hours)
研究概览
简要总结
Postoperative pain control is a substantial problem with laparoscopic cholecystectomy, a common surgical procedure. Thoracic epidural analgesia was gold standard for reducing pain after thoracic and upper abdominal surgeries.
Erector spinae plane block(ESPB),a relatively a new block has been shown to have beneficial effects on post operative analgesia in neuropathic pain,thoracic surgical procedures and upper abdominal surgeries.
The aim of this prospective randomized single blinded study is to compare thoracic epidural analgesia and ultrasound guided erector spinae plane block for post operative management following laparoscopic cholecystectomy using local anaesthetic ropivacaine with dexmedetomidine.
A total of 80 patients ,aged 18-60 years belonging to American society of Anaesthesiologists(ASA) I and II scheduled to undergo laparoscopic cholecystectomy will be enrolled in the study and divided into two groups. According to compture generated table,patients in group A will receive Thoracic epidural analgesia with local anaesthetic 0.375% ropivacaine and 7.5 microgram dexmedetomidine and the group B will receive ESPB with local anaesthetic 0.187% ropivacaine with 7.5 microgram dexmedetomidine bilaterally. The data will be collected ,entered in master chart ,analysed using the student’s ’t’ test for continuous data and the chi-square test for categorical data as and where appropriate.The findings and observations made during the entire study will be tabulated,graphically depicted whenever possible,statistically analysed and inference drawn.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either sex b.
- •Age group- 18 to 60 yrs.
- •American society of anesthesiologists (ASA) Grade I or Grade II d.
- •BMI: 18 to 30 kg/m2 e.
- •Weight:40-70 kg.
排除标准
- •Patient refusal b.
- •An allergy to local anaesthetics c.
- •Contraindication to epidural anaesthesia (abnormal coagulation status, a local infection, preexisting neurological deficit of torso or lower limb, and spinal diseases) d.
- •Pregnancy e.
- •Cognitive impairment.
结局指标
主要结局
1.Duration of analgesia(hours)
时间窗: Outcomes will be recorded at 0,6,12,and 24 hours. Data collected will be assessed at the end of one year
2.Time to first rescue analgesic
时间窗: Outcomes will be recorded at 0,6,12,and 24 hours. Data collected will be assessed at the end of one year
3.Total dose of rescue analgesics consumed in first 24hours
时间窗: Outcomes will be recorded at 0,6,12,and 24 hours. Data collected will be assessed at the end of one year
4.Pain score using Visual analogue scale(VAS)at 0,6,12,24 hours(postoperative)
时间窗: Outcomes will be recorded at 0,6,12,and 24 hours. Data collected will be assessed at the end of one year
次要结局
- 1.Hemodynamic profile-pulse rate,systolic blood pressure(SBP),diastolic blood pressure(DBP),mean arterial pressure(MAP)(2.Complications(postoperative):)
研究者
LIPPI LOLLEN
Regional Institute of Medical Sciences,Imphal West