The Analgesic Effect Of Sacral Erector Spinae, Penile And Caudal Block For Pain Relief After Hypospadius Surgery: Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Time to the first analgesic request
研究概览
简要总结
Caudal anaesthesia is recommended for most surgical procedures of the lower part of the body, mainly below the umbilicus, including inguinal hernia repair, urinary and digestive tract surgery and orthopaedic procedures on the pelvic girdle and lower extremities.
It has been well established that a dorsal penile nerve block immediately after surgery decreases postoperative pain in children undergoing hypospadias repair. For decades, penile block was widely and effectively used for various types of penile reconstructive surgery.
Recently, due to improved composition, dosage and concentration of local anaesthetics and low incidence of negative side effects, such as motor blockade and postoperative nausea and vomiting, caudal anaesthesia has become one of the most used and accepted regional blocks for children undergoing hypospadias repair.
However, postoperative patient comfort is a major issue after distal hypospadias repair and depends on adequate analgesia and unimpaired micturition, especially when no suprapubic catheter is in place. Micturition impairment and urinary retention is a known side effect of caudal block anaesthesia.
The comparison of penile block and caudal block has not been described in the literature to our knowledge.
Use of ESPB for different indications from different levels has become the new trend of regional anesthesia practice from the moment it was first defined . There have been many reports for its use in thoracic and lumbar levels.
This great interest probably depends on its effectiveness as well as the ease of the block technique: injecting the local anesthetic deep to the erector spinae muscle (ESM) above the transverse process. With this report, we would like to identify a modification to sacral ESPB with our longitudinal midline approach with the presentation of a case of an infant who was scheduled for hypospadias repair.
详细描述
Patients will be randomly divided into three groups by using a computer-generated randomization. Sealed opaque envelopes containing group allocation will be before the blocks will be performed. Then, each patient will be asked to choose one of the envelopes and give to an anesthesiologist who will compare it to the computer-generated list and hence assignee her to one of the three groups. Anesthesiologist (who will be blinded to the collected data until the end of the study) will perform the block techniques and administer the medication.
- Group C (Caudal group) n=44: after prep and drep, in left lateral position caudal block will be performed with bupivacaine 0.25%, 1 ml/kg (max 20 ml).
- Group P (Penile block) n=44: after prep and drep in supine position, the penis will be retracted downward and fixed with leucoplast. The markers for injection will be, symphysis pubis, 0.5 to 1 cm lateral to the midline, the needle will be inserted vertically (medially-caudally) until penetrating fascia scarpa and bupivacaine 0.5%, 0.1 ml/kg (max 2.5 ml), will be injected in each side. Blocks will be performed with 22-G needles and skin incision will be performed 20 minutes after block in each group.
- Group E (Erector spinea plain block group) n=44:
Before the start of surgery, patient will be turned to prone position for block application. Following cleansing of the block area, linear ultrasound probe (Esaote My Lab 6 US machine, Florence, Italy) will be placed longitudinally to midline just above the sacrum . Median sacral crests and erector spinae muscle will be identified.
A 22G, 50mm needle (B. Braun Melsungen, Germany) will be inserted from the edge of the probe using in-plane technique. Needle will be advanced with a cranial to caudal direction until its tip touched to the top of the 4th median sacral crest. Following negative aspiration, 8 mL of 0, 25% Bupivacaine (with a dose of 1 mL/kg) will be injected for the block application. Then the patient will be turned to supine position and surgery started.
Anesthesia Protocol All the patients will be adequately assessed preoperatively in the anesthesia clinic through history taking, general and local examination, and requesting investigation. Adequate explanation of the procedure, benefit, and potential hazards will be done to the parents with final reassurance of them. All children will receive sedation in the form of oral midazolam 0.05 mg/kg 15 minutes before admission to the operating room.
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, Investigator)
入排标准
- 年龄范围
- 1 Year 至 5 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria was patients with distal penile, subcoronal and coronal type of hypospadias, scheduled for repair with an intermittent non-dribbling urethral stent for 7 days or less.
排除标准
- •Bleeding diathesis
- •Known allergy to local anesthesia medications
- •Active infection at the injection area
- •History of developmental delay
- •Mental retardation (due to difficult pain assessment).
结局指标
主要结局
Time to the first analgesic request
时间窗: 24 hours postoperative
The time (in hours) from the beginning of the block to the first rescue analgesia request was recorded
次要结局
- Face, Legs, Activity, Cry, and Consolability (FLACC) Score(24 hours Postoperative)
- The incidence of perioperative complications.(24 hour postoperatively)
- The total amount of analgesia(24 hours Postoperative)
- Penile engorgement(Intraoperatively)
研究者
Amr Arafa Elbadry
Principle Investigator
Tanta University