跳至主要内容
临床试验/CTRI/2023/07/054892
CTRI/2023/07/054892尚未招募不适用

Comparison of ultrasound-guided erector spinae plane block and ultrasound-guided transversus abdominis plane block for post-operative analgesia in children undergoing lower abdominal surgery under general anaesthesia.

Department of Anaesthesia1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年7月16日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
70
试验地点
1
主要终点
Average CHEOPS score till first rescue analgesia.

研究概览

简要总结

AIM

To compare ultrasound-guided erector spinae plane block and ultrasound-guided transversus abdominis plane block for post-operative analgesia in children undergoing lower abdominal surgery under general anaesthesia.

OBJECTIVES

Primary Objective

To compare ultrasound-guided erector spinae plane block and ultrasound-guided transversus abdominis plane block for post-operative analgesia in children undergoing lower abdominal surgery under general anaesthesia.

Secondary Objectives

  1. Time taken for the first rescue analgesia.

  2. To find out total rescue analgesia requirement in 12 hours in each group.

METHODOLOGY

Pre anaesthetic evaluation will be done for all the patients one day before the day of surgery. They will be instructed to be nil per oral (NPO) at least 8 hours for solids, 6 hours for formula/non-human milk, 4 hours for breast milk and 2 hours for clear fluids. Written informed consent for study procedures will be obtained from the parents of the patients. On the day of surgery all patients will be re-assessed in the preoperative area. ASA standard monitors will be attached which includes Non-invasive blood pressure (NIBP), three lead electrocardiography (ECG) and Masimo Pulse oximetry (SpO2) will be placed on the index finger of the upper extremity. Baseline parameters will be noted. General anesthesia will be induced with incremental sevoflurane in 100% oxygen which will be followed by placement of intravenous cannula. After securing IV cannula, injection fentanyl 2μg/kg intravenously and injection vecuronium 0.1mg/kg intravenously will be given. Patients will be mask ventilated for 3 minutes using oxygen and inhalational sevoflurane to achieve MAC of 1 ± 0.2. Airway will be secured with appropriate size laryngeal mask airway.

Before proceeding to the surgery, under all aseptic precautions, ultrasound-guided transversus abdominis plane block will be performed in one group and ultrasound-guided erector spinae plane block will be done in the other group.

Ultrasound guided erector spinae plane block technique –

After all aseptic preparation, under ultrasound guidance erector spinae plane block will be performed. The linear transducer of 10-14 MHz will be used after sterile gel and sterile plastic cover application. The probe will be placed into a longitudinal, parasagittal orientation over the tip of the transverse processes of L2. A needle will be inserted in-plane, in a cranialâ€toâ€caudal direction until contacting the tip of the transverse process (L2) underneath the fascia of the erector spinae muscle. Local anaesthetic drug 0.25% bupivacaine will be injected at 0.5ml/kg, after careful aspiration. The spread of local anaesthetic will be observed using the ultrasound.

Ultrasound guided transversus abdominis plane (TAP) block

Ultrasound guided transversus abdominis will block will be performed under strict aseptic precautions using a linear transducer of 10-14 MHz after sterile gel and sterile plastic cover application ultrasound probe will be placed on the lateral abdominal wall cephalad to the iliac crest and caudal to the costal margin. The probe will be adjusted as necessary in cephalad or caudal direction until a clear optimized image of the three lateral abdominal muscles and TAP is obtained. The needle tip will be introduced into the TAP plane between internal oblique and transversus abdominis muscles using in plane technique and the drug 0.25% bupivacaine at 0.5ml/kg will be administered into the plane. The spread of local anaesthetic within the plane will be observed.

POST- OPERATIVE PAIN MANAGEMENT:

The following parameters will be assessed in the recovery room –

  1. The duration of analgesia will be assessed by the time period between the administration of the block and the time of the first rescue analgesia.

  2. The quality of the pain will be assessed by the CHEOPS score after the arrival of the patient in the recovery room at 15 minutes, 30 minutes, 1, 2, 4, 6, 9 and 12 hours.

Patients with CHEOPS score equal to or more than 6 will be given injection paracetamol 10 mg/kg intravenously as rescue analgesia for post-operative pain.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
6.00 Month(s) 至 7.00 Year(s)(—)
性别
All

入选标准

  • Age 6 months to 7 years.
  • ASA grade I
  • Patients undergoing lower abdominal surgery.

排除标准

  • 1.Refusal of Consent from parents.
  • Allergy to local anaesthesia 3.Infection at injection site.

结局指标

主要结局

Average CHEOPS score till first rescue analgesia.

时间窗: After the arrival of the patient in the recovery room at 15 minutes, 30 minutes, 1, 2, 4, 6, 9 & 12 hours.

次要结局

  • 1. Total rescue analgesia given in 12 hours.(2. Time taken for the first rescue analgesia.)

研究者

申办方类型
Government medical college

研究点 (1)

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