Comparison of Caudal Blockade and Dorsal Penile Nerve Block With and Without the Intravenous Administration of Dexamethasone for Analgesia After Paediatric Male Circumcision: a Single Centre Randomized-controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Postoperative analgesic effect
研究概览
简要总结
Male infant circumcision is a frequently performed, but painful procedure. A variety of methods, both systemic and locoregional, have been developed to overcome postoperative pain after circumcision. It has been shown that local anesthetic techniques are more effective than opioids. Especially caudal block and dorsal penile nerve block provide adequate early analgesia (up to 2 hours) after circumcision.
Although the postoperative analgesic effects of CB and DPNB have been evaluated in literature before, these two techniques that are commonly used in circumcision surgery in the paediatric population, have not yet been compared when using DXM as an adjuvant in both methods. On the other hand, to our knowledge there is no evidence that indicates any other advantage than a reduced incidence in PONV when it comes to circumcision patients having a DNPB with IV DXM.
Therefore, this study aims to evaluate the analgesic effect of CB using levobupivacain with IV DXM compared to DPNB using levobupivacain with IV DXM and DPNB without IV DXM. It is questioned whether the addition of IV DXM to the DPNB might shift our standard of care towards a locoregional technique avoiding the neuraxial route, without losing the analgesic quality of the combination of a CB with IV DXM.
详细描述
All male infant patients, between ≥ 1 and < 7 years of age, undergoing circumcision will be randomized in a 1:1:1 ratio to the
- Caudal blockade group with dexamethasone or;
- Dorsal penile nerve block group with dexamethasone or;
- Dorsal penile nerve block group withouth dexamethasone.
After induction of anaesthesia the allocated locoregional anaesthesia technique will be performed.
For the caudal blockade group levobupivacaine 0,25% 0,5ml/kg will be administered through the hiatus sacralis lege artis. After performing the caudal blocakde, IV administration of dexamethasone 0.5 mg/kg (max. 5 mg).
For the dorsal penile nerve block levobupivacaine 0,5% 0,1ml/kg will be administered on each side of the midline as described in Hadzic's textbook of regional anaesthesia. After performing of the dorsal penile nerve block, IV administration of dexamethasone 0.5 mg/kg (max. 5 mg) in patients in the dorsal penile nerve block group with dexamethasone .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
patient and parents, recovery nurses and study nurse will be blinded.
入排标准
- 年龄范围
- 1 Year 至 7 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male paediatric patients, between ≥ 1 and < 7 years of age
- •Patients scheduled for paediatric male circumcision (sleeve resection technique)
- •Signed written informed consent form
排除标准
- •Patients known with allergy to study medication (in this case levobupivacaine, dexamethasone, tramadol, diclofenac, paracetamol, sufentanil)
- •ASA score 3 or higher (ASA physical satus classification system)
- •Delayed motor development/inability to stand up
- •Patients who receive medication that could possibly interact with levobupivacaine (mexiletine, ketoconazole, theophylline)
- •Patients who simultaneous participate in another interventional clinical trial
- •Inability of parents to understand Dutch in a sufficient way
- •Soft tissue infection in the area of the procedure
- •Coagulation disorder
- •Spina bifida
- •Autism spectrum disorder
- •Ulcus ventriculi and duodeni
- •Systemic fungal, bacterial and parasitic infections
- •Administration of live or live-attenuated vaccins during the use of dexamethasone
研究组 & 干预措施
Caudal blockade (with levobupivacaine) and dexamethasone IV
Administration of levobupivacaine 0,25% 0,5 ml/kg through the hiatus sacralis lege artis. IV administration of dexamethasone 0,5mg/kg (max. 5mg) during standard anaesthetic management.
干预措施: Dexamethasone (Drug)
Caudal blockade (with levobupivacaine) and dexamethasone IV
Administration of levobupivacaine 0,25% 0,5 ml/kg through the hiatus sacralis lege artis. IV administration of dexamethasone 0,5mg/kg (max. 5mg) during standard anaesthetic management.
干预措施: Caudale Blockade with levobupivacaine (Procedure)
Dorsal penile nerve block (with levobupivacaine) and dexamethasone IV
Administration of levobupivacaine 0,5% 0,1ml/kg on each side of the midline as described in Hadzic's textbook of regional anaesthesia. IV administration of dexamethasone 0,5mg/kg (max. 5mg) during standard anaesthetic management.
干预措施: Dexamethasone (Drug)
Dorsal penile nerve block (with levobupivacaine) and dexamethasone IV
Administration of levobupivacaine 0,5% 0,1ml/kg on each side of the midline as described in Hadzic's textbook of regional anaesthesia. IV administration of dexamethasone 0,5mg/kg (max. 5mg) during standard anaesthetic management.
干预措施: Dorsal penile nerve block with levobupivacaine (Procedure)
Dorsal penile nerve block (with levobupivacaine)
Administration of levobupivacaine 0,5% 0,1ml/kg on each side of the midline as described in Hadzic's textbook of regional anaesthesia.
干预措施: Dorsal penile nerve block with levobupivacaine (Procedure)
结局指标
主要结局
Postoperative analgesic effect
时间窗: 24 hours postoperative
Analgesic effect of a caudal blockade after circumcision in paediatric patients compared to dorsal penile nerve block after circumcision in paediatric patients measured by the FLACC scale (= Face, Legs, Activity, Cry, Consolability) at 30 minutes, 1, 2, 6, 12 and 24 hours postoperative
次要结局
- Incidence of nausea and vomiting (PONV)(From PACU admission until 24 hours postoperative)
- Need for escape analgesia(From PACU admission until hospital discharge (up to 48 hours))
- Time to micturition(From PACU admission until hospital discharge (up to 48 hours) (measured every 30 minutes starting from PACU admission until hospital discharge))
- Total procedure time(perioperative)
- Length of hospital stay(From hospital admission until hospital discharge (up to 48 hours))
- Time to standing up(From PACU admission until hospital discharge (up to 48 hours) (measured every 30 minutes starting from PACU admission until hospital discharge))
- Need for supplemental sufentanil intraoperatively(perioperative)
研究者
Joris Goossens, MD
Principal Investigator
Algemeen Ziekenhuis Maria Middelares