A prospective randomized controlled trial comparing caudal epidural block, ultrasound guided illioinguinal/ iliohypogastric nerve blocks and ultrasound guided transversus Abdominis plane block in paediatric patients undergoing elective inguinal region surgeries.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- The primary end point will be time to first rescue analgesia (paracetamol (PCM)).
研究概览
简要总结
Aim of study
We hypothesize that ultrasound guided nerve block (TAP and IL/IH) will provide better post operative analgesia as compared to CEB for inguinal region surgeries in children.
We would enroll American Society of Anesthesiologists physical status I–II patients aged between 6 months and 8 years scheduled for elective unilateral inguinal surgery (inguinal herniotomy, hydrocelectomy,orchidopexy). Written informed consent for study procedures will be obtained from all parents.
Group C = caudal block group (receive 0.75ml/kg of 0.2% ropivacaine)
Group T = usg guided TAP block group (receive 0.3ml/kg of 0.2% ropivacaine)
Group I = usg guided IL/IH nerve block (receive 0.1ml/kg of 0.2% ropivacaine)
All patients will receive standard general anaesthesia
Block procedure-
USG IL/IH nerve block-
Using 6-13 Hz ultrasound probe block will be performed keeping the probe cephalad to the anterior superior iliac (ASIS) crest parallel to the line joining umbilicus and ASIS. After visualisation of the IL/IH nerves between inferior oblique and transversus Abdominis muscles, using in plane technique, 22 G hypodermic needle will be introduced, tip of the needle would be followed and hydrodissection with saline would be done for confirmation and local anaesthetic (0.1ml/kg of 0.2% ropivacaine) will be injected such that it surrounds the nerves.
CEB
Patient would be placed in the left lateral position. The sacral hiatus between the sacral cornu would be palpated. With 23�’G short needle sacral puncture would be made with the bevel toward the abdomen at a 45�’degree angle. When the sacrococcygeal ligament seemed to have been punctured, the needle would be tilted more toward the skin surface and inserted 2�’3�’mm deeper. Negative aspiration would confirm any inadvertent blood vessel or dural puncture. Confirming, 0.75ml/kg of 0.2% ropivacaine would be injected in 2ml aliquots after intermittent careful negative aspirations.
USG TAP block
Ultrasound probe (6-13Hz) would be kept cephalad to the ASIS keeping the probe parallel to line joining umbilicus and ASIS, keeping the probe at the anterior axillary line level, using hypodermic needle 22G using in plane technique needle will be inserted till the tip of the needle reaches interface between inferior oblique and transversus Abdominis and hydrodissection will be done using saline after confirmation local anaesthetic (0.3ml/kg of 0.2% ropivacaine) will be injected.
The primary end point will be time to first rescue analgesia (paracetamol (PCM)). Secondary parameters would be total intra operative fentanyl consumption, time in image acquisition and drug injection, total post operative PCM consumption, pain and sedation scores, total number of patients requiring rescue analgesia (PCM), incidence of post op nausea vomiting, parental satisfaction scores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 6.00 Month(s) 至 8.00 Year(s)（—）
- 性别
- All
入选标准
- •We would enroll American Society of Anesthesiologists physical status I–II patients scheduled for elective unilateral inguinal surgery (inguinal herniotomy, hydrocelectomy,orchidopexy).
排除标准
- •Exclusion criteria will include regional block refusal, known amide local anesthetic drug allergy, history of seizures or neurological, neuromuscular, psychiatric or blood clotting disorders, a history of clinically important renal, hepatic, cardiac, or neurological conditions.
结局指标
主要结局
The primary end point will be time to first rescue analgesia (paracetamol (PCM)).
时间窗: In PACU pain scoring would be done every 15 minutes during the first hour in PACU and every 30 minutes for the next 3 hours in until discharge from the hospital. Pain will be assessed using FLACC Behavioural Pain Scale and Baker-Wong Faces Scale. If pain scores more than 6 they will be treated with injection fentanyl 0.5 microgram /kg and if pain scores more than 3 (FLACC)/more than 4(Baker Wong faces) injection paracetamol will be given
次要结局
- Secondary parameters would be total intra operative fentanyl consumption, time in image acquisition and drug injection, total post operative PCM consumption, pain and sedation scores, total number of patients requiring rescue analgesia (PCM), incidence of post op nausea vomiting, parental satisfaction scores.(During the intraoperative course Vital parameters including heart rate, blood pressure and saturation will be recorded every 1minute for first 5minutes after block placement, at the time of skin incision, 5, 10 and 15 mins later. In PACU pain scoring and sedation scoring would be done every 15 minutes during the first hour in PACU and every 30 minutes for the next 3 hours in until discharge from the hospital.Incidence of nausea vomiting in PACU and parental satisfaction scores after 24 hours.)