A study to compare effectiveness of erector spinae plane block and transverses abdominis plane block in inguinal hernia repair for post operative analgesia
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Is to compare the post operative analesia of ultrasound
研究概览
简要总结
Inguinal hernia surgery is one of the commonly performed surgical procedures worldwide, which is associated with substantial postoperative pain and distress requiring effective analgesia. Multimodal analgesia is used to control postoperative pain in inguinal hernia repair. Transversus abdominis plane (TAP) block is one of the approaches to provide effective postoperative analgesia in patients undergoing hernia surgeries. The erector spinae plane(ESP) block is a recently described regional anaesthesia technique, when applied to low thoracic region was reported to provide extensive, potent unilateral analgesia in these surgeries by acting on both dorsal and ventral branches of thoracic spinal nerves. In this study, we aimed to determine and compare the effect of transversus abdominis plane block and erector spinae plane block on postoperative pain in patients undergoing inguinal hernia repairs under subarachnoid block.
PRIMARY OBJECTIVE: Is to compare the post operative analgesia of ultrasound guided Erectorspinae plane block with Transverse abdominis plane block in inguinal hernia repair.
SECONDARY OBJECTIVE; is to compare
1.Haemo dynamic stability
2.Number of failure of block with both techniques
3.Complications following blocks
METHODOLOGY:
A brief history and detailed general examination will be performed in all participants. Consent will be duly signed. All the patients will be kept overnight fasting of 8 hours prior to the scheduled day of surgery. Once the patient is received in the preoperative area, vital parameters such as respiratory rate, heart rate, saturation of oxygen (SpO2), blood pressure and ECG changes will be monitored and noted. Intravenous line will be secured with either 20G or 18G IV cannula. The selected patients will be randomly assigned to two subsequent groups, n=30 each, based on a computer randomization.
Active Comparator: ESP Block Ultrasound-guided Erector spinae plane (ESP) block will be performed at the finishing of the surgery with 30 ml of a bupivacaine/lidocaine mixture. The postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patientcontrolled analgesia) with no additional intervention (block) Standard Pain Followup and Monitorization will be performed Procedure: ESP Block ESP block will be performed at the finishing of surgery under spinal anesthesia. A convex ultrasound transducer will be placed in a longitudinal parasagittal orientation 2-3 cm lateral to T10 spinous process. The erector spinae muscles will be identified superficial to the tip of T10 transverse process. The patient’s skin will be anesthetized with 2% lidocaine. A 22-gauge 10- cm needle will be inserted using an out-plane superior-to-inferior approach to place the tip into the fascial plane on the deep (anterior) aspect of erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting erector spinae muscle off the bony shadow of the transverse process. A total of 30 mL of bupivacaine/lidocaine mixture will be injected. Other: Standard Pain Followup and Monitorization Numeric Rating Scale (NRS) pain score will be recorded and followed by 0., 1.-3.-6.-12.-18.- 24.hours. it is planned that the patient will continue to follow the hourly NRS score in ward. Intramuscular diclofenac will be administered in this period if NRS 4 and if it is over, intravenous 0.5 mg / kg meperidine will be administered if NRS score is 4 or more after 2 hours. Salvage analgesic needs and times will be noted in detail, and the use of rescue analgesics, as well as NRS scores at designated hours, will be kept in a statistical evaluation. TAP Block Ultrasound-guided Transversus abdominis plane (TAP) block will be performed at the finishing of the surgery with 30 ml of a bupivacaine/lidocaine mixture. The postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block) Standard Pain Followup and Monitorization will be performed Procedure: TAP Block TAP block will be performed at the finishing of surgery under spinal anesthesia. A linear ultrasound transducer will be placed to lateral aspect of abdomen. A 22-gauge 10-cm needle will be inserted using an out-plane superior-to-inferior approach to place the tip into the fascial plane between transversus abdominis and internal oblique muscles..A total of 30 mL of bupivacaine/lidocaine mixture will be injected Sham Comparator: Control The postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block) Standard Pain Followup and Monitorization will be performed. Other: Standard Pain Followup and Monitorization Numeric Rating Scale (NRS) pain score will be recorded and followed by 0., 1.-3.-6.-12.-18.- 24.hours. it is planned that the patient will continue to follow the hourly NRS score in ward. Intramuscular diclofenac will be administered in this period if NRS 4 and if it is over, intravenous 0.5 mg / kg meperidine will be administered if NRS score is 4 or more after 2 hours. Salvage analgesic needs and times will be noted in detail, and the use of rescue analgesics, as well as NRS scores at designated hours, will be kept in a statistical evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •• Patients of either sex, aged between 18-70 years belonging to American Society of Anaesthesiologists (ASA) physical status I and II posted for hernioplasty were included in the study.
排除标准
- •• Patient refusal .
- •• Contraindications to regional anesthesia • Known allergy to local anesthetics • Bleeding diathesis • Use of any anti-coagulants • Inability to provide informed consent • Severe kidney or liver disease • Inability to operate PCA system • Patient with psychiatric disorders • Patients with ASA grade IV.
结局指标
主要结局
Is to compare the post operative analesia of ultrasound
时间窗: 24 HOURS
guided Erectorspinae plane block with Transverse abdominis plane block in inguinal
时间窗: 24 HOURS
hernia repair.
时间窗: 24 HOURS
次要结局
- is to compare(1.Haemodynamic stability)
研究者
Sweta Gajapure
Acharya Vinobha Bhave Rural Hospital,JNMC
