Caudal Epidural Block Versus Topical Ketamine Application for Postoperative Pain Relief After Elective Inguinal Herniotomy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- time to first request for postoperative analgesia
研究概览
简要总结
To find alternatives to caudal analgesia that could be more safe and effective and to demonstrate the analgesic efficacy of topical ketamine.
详细描述
The most commonly performed inguinal surgeries in children include inguinal hernia repair with or without orchidopexy (orchiopexy). Eighty children aged 6 months to 6 yr of ASA physical status I or II, undergoing elective unilateral inguinal herniotomy will be included. In caudal group, patients will receive a mixture of 0.5 mg/ kg ketamine in 1 ml/kg bupivacaine 0.25% (maximum volume = 20 ml) by caudal route after anesthesia and before start of surgery. In topical group, at the end of the procedure, after identification and ligation of the hernial sac, a mixture of 0.5 mg/ kg ketamine in 0.3 ml/kg bupivacaine 0.25% will be sprayed around the spermatic cord and upon the ilioinguinal nerve in a fan shaped manner by the surgeon. The primary outcome measure will be the time to first request for analgesia. Secondary outcome measures will include the number of analgesic doses required in the first 24 h postoperative, pain scores, sensory and motor block, agitation scores, parent satisfaction and adverse effects in the first 48h postoperative.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 6 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •age (6 months to 6 years)
- •ASA physical status I or II.
- •Operation: elective unilateral inguinal herniotomy.
排除标准
- •A history of developmental delay or mental retardation,
- •Known or suspected coagulopathy,
- •Known allergy to any local anaesthetic,
- •Known congenital anomaly of the spine or signs of spinal anomaly,
- •Infection at the sacral region.
研究组 & 干预措施
Topical ketamine and topical bupivacaine
0.5 mg/ kg ketamine in 0.3 ml/kg bupivacaine 0.25% (maximum volume = 20 ml) administered directly around the spermatic cord in the wound after end of surgery and before closure of the wound.
干预措施: Ketamine (Drug)
Topical ketamine and topical bupivacaine
0.5 mg/ kg ketamine in 0.3 ml/kg bupivacaine 0.25% (maximum volume = 20 ml) administered directly around the spermatic cord in the wound after end of surgery and before closure of the wound.
干预措施: Bupivacaine (Drug)
Caudal ketamine and caudal bupivacaine
0.5 mg/ kg ketamine in 1 ml/kg bupivacaine 0.25% (maximum volume = 20 ml) administered by caudal epidural route after anesthesia and before the start of surgery.
干预措施: Ketamine (Drug)
Caudal ketamine and caudal bupivacaine
0.5 mg/ kg ketamine in 1 ml/kg bupivacaine 0.25% (maximum volume = 20 ml) administered by caudal epidural route after anesthesia and before the start of surgery.
干预措施: Bupivacaine (Drug)
结局指标
主要结局
time to first request for postoperative analgesia
时间窗: 48 hours postoperative
time in hours from admission to PACU till first request for analgesia
次要结局
- total consumption of postoperative analgesics(48 hours postoperative)
- The Children's Hospital of Eastern Ontario Pain Scale (CHEOPS, 0-10) pain score(180 minutes postoperative)
- Faces Legs Activity Cry Consolability tool (FLACC, 0-10).(180 minutes postoperative.)
- the agitation score (0= child is asleep, 1= awake/calm, 2= irritable/ consolable cry, 3=inconsolable cry, 4= the child is agitating and thrashing and restlessness).(60 minutes postoperative)
- parent's satisfaction on a four-point Likert scale (1, excellent; 2, good; 3, fair; 4, poor).(48 hours postoperative)
- noninvasive blood pressure(Intra-operative)
- heart rate(Intra-operative)
- Verbal Numeric Rating Scale (VNRS)(48 hours postoperative)
研究者
Hala Saad Abdel-Ghaffar
assistant professor anesthesia and intensive care department/ faculty of medicine/ Assiut university/ Egypt.
Assiut University