A clinical trial to compare the efficacy of two plane blocks,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.
- Conditions
- Acute pain, not elsewhere classified,
- Registration Number
- CTRI/2023/07/054892
- Lead Sponsor
- Department of Anaesthesia
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 70
- Age 6 months to 7 years.
- ASA grade I 3.
- Patients undergoing lower abdominal surgery.
- 1.Refusal of Consent from parents.
- Allergy to local anaesthesia 3.Infection at injection site.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Average CHEOPS score till first rescue analgesia. After the arrival of the patient in the recovery room at 15 minutes, 30 minutes, 1, 2, 4, 6, 9 & 12 hours.
- Secondary Outcome Measures
Name Time Method 1. Total rescue analgesia given in 12 hours. 2. Time taken for the first rescue analgesia.
Trial Locations
- Locations (1)
ABVIMS and Dr.RML Hospital
🇮🇳Delhi, DELHI, India
ABVIMS and Dr.RML Hospital🇮🇳Delhi, DELHI, IndiaDr S VigneshPrincipal investigator9543414570vickyshanmugavel@gmail.com