Dexmedetomidine Versus Clonidine Adjuvants to Levobupivacaine for Transversus Abdominis Plane Block in Pediatric Laparoscopic Orcheopexy: Randomized Double-blind Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- modified CHEOPS
研究概览
简要总结
A laparoscopic approach offers several advantages over an open procedures; potentially reduces the surgical stress and fluid shifts that may accompany it; in addition there is less need for postoperative analgesia, reduction of postoperative respiratory and wound complications.
Despite the minimally invasive nature, pain can be moderate to severe in the immediate postoperative period that requires multimodal analgesia. Inadequate control of post-operative pain leads to several unwanted adverse events ranging from patients' discomfort and prolonged immobilization to thromboembolic phenomenon and pulmonary complications.
Transversus abdominis plane (TAP) block is a type of peripheral nerve block that involves innervation of the anterolateral abdominal wall. With the aid of ultrasound, local anesthetic (LA) is injected into the transversus abdominis fascial plane, where the nerves from T6 to L1 are located.
Ultrasound TAP block is accompanied by a good pain relief and reduced intraoperative and postoperative opioids requirements after laparoscopic surgery. In this case a bilateral TAP block is necessary because the abdominal skin incisions for the ports of laparoscopic procedure are performed on both sides.
Unfortunately, TAP block duration is limited to the effect of administered LA. Recently, adjuvant medications were added to LA to prolong the effect of TAP block. Dexmedetomidine is a selective alpha 2 (α2) adrenergic agonist with both analgesic and sedative properties. Its use with bupivacaine either epidurally or intrathecally is associated with prolongation of the LA effect. A major advantage of dexmedetomidine is its higher selectivity compared with clonidine for α2A receptors, responsible for the hypnotic and analgesic effects of such drugs.10 Clonidine action, similar to local anesthetic action, and its interaction with local anesthetics have been explained by three possible mechanisms. First, clonidine blocks Ad and C fibers. Secondly, clonidine may cause local vasoconstriction, thus decreasing local anesthetic spread and removal around neural structures. Thirdly, clonidine used in peripheral blocks intensifies and prolongs analgesia.
详细描述
Preoperative assessment:
The day prior to surgery, all children will undergo pre-anesthetic checkup including detailed history, thorough general, physical, systemic examination and weight of the patient. All children will be kept nil per mouth 8 hours for solids and 2 hours for clear liquids.
Preparation of the patient:
- Written consent, coagulation profile, emergency resuscitation equipments including airway devices, pediatric advanced life support drugs for LA toxicity will be available.
- All patients will be pre-medicated with oral midazolam of 0.5 mg/kg about 20 minutes before induction of anesthesia.
Intraoperative management:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 8 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •ASA I-II physical status patients.
- •Age between 3 and 8 years.
- •Children undergoing laparoscopic orcheopexy.
排除标准
- •Parent refusal
- •History of developmental delay or mental retardation, which will make observational pain intensity assessment difficult
- •Hypersensitivity to any local anesthetics
- •Bleeding diathesis
- •History of renal, hepatic, cardiac, upper or lower airway or neurological diseases
- •Any sign of infection at the puncture site of the proposed block
- •History of sleep apnea with which postoperative ventilation may be required
研究组 & 干预措施
DEXMEDETOMIDINE
patients will receive ultrasound-guided TAP block using 0.3 ml/kg levobupivacaine (0.125%) with a maximum volume of 20 ml each side + 0.5 ug/kg dexmedetomidine Hydrochloride dissolved in 2 ml normal saline (NaCl 0.9%).
干预措施: Dexmedetomidine (Drug)
CLONIDINE
patients will receive ultrasound-guided TAP block using 0.3 ml/kg levobupivacaine (0.125%) with a maximum volume of 20 ml + 0.5 ug/kg clonidine dissolved in 2 ml normal saline (NaCl 0.9%).
干预措施: Clonidine (Drug)
LEVOBUPIVACAINE
patients will receive ultrasound-guided TAP block using 0.3 ml/kg levobupivacaine (0.125%) with a maximum volume of 20 ml + 2 ml normal saline (NaCl 0.9%).
干预措施: Levobupivacaine (Drug)
结局指标
主要结局
modified CHEOPS
时间窗: 24 hours
postoperative pain assessment score in children
次要结局
- 5-point Likert scale(24 hours)
- complications(24 hours)
- sedation score(24 hours)
研究者
RAGAA AHMED HERDAN
Lecturer of Anesthesia and Intensive Care
Assiut University