Pudendal vs Caudal Block for Pediatric Penile Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Analgesic Consumption
研究概览
简要总结
The study will compare recovery profile in children receiving pudendal blocks vs caudal analgesia for ambulatory circumcision or hypospadias repair in children between 6 months and 2 years. The subjects of the study will be randomized to receive either a caudal or a pudendal block.
详细描述
The study participation will begin on the day of surgery and end at the time of last surgical follow-up visit, approximately two weeks later. All procedure related, follow-up clinic visit and PACU data will be collected by the research team from the patient's EPIC record (demographic data, pain scores in the PACU, analgesic consumption, time to perform block, time to discharge, etc). Data pertaining to the recovery of patient at home will be collected via phone call or email to the caregiver of the child. Late complications will be identified by reviewing the follow-up surgical note.
Questionnaire Administration The physical Pain journal/questionnaires
The physical Pain journal/questionnaires will be handed out to the caregiver before discharge from the Post-Anesthesia Care Unit.
The caregiver will fill out pain scores at home in the Pain Journal. The pain scores used (FLACC and PPPM) have been extensively validated. In addition, written instructions for using the pain scores to guide pain management interventions at home will be provided. Prior to discharge, caregivers will also be educated by a member of the research team on pain evaluation using the pain score and pain management algorithm.
The caregiver will be asked to answer a short questionnaire (Postoperative Parent Survey) about their child pain in the first 24 hours after discharge from the hospital. The caregiver will receive a phone call from the research team 24-48 hours after discharge to retrieve the results of the Pain Journal and Postoperative Pain Survey.
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 (Participant, Outcomes Assessor)
盲法说明
The study will be an observer-blinded RCT. The surgeon, regional pediatric anesthesiologist, and operating room staff (anesthesiologists and nurses) will not be blinded to the treatment group. However, the patient and family, recovery room nurses, and study coordinator who collects the data from families will be blinded
入排标准
- 年龄范围
- 6 Months 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Children Aged 6 months -3 years
- •Scheduled for elective outpatient circumcision or hypospadias repair
排除标准
- •ASA classification ≥ 3
- •emergency surgery
- •history of a complex regional pain syndrome
- •sacral dimple
- •known vertebral spinal abnormalities, spinal dysraphism
- •history of long-term analgesic use
- •use of any analgesic (e.g., an opioid medication, acetaminophen, or a nonsteroidal anti-inflammatory agent) within 24 hours before surgery
- •history of renal insufficiency or a bleeding disorder
- •concurrent additional surgery at another anatomic site
- •being a ward of the state
- •a non-English speaking patient or primary caregiver
- •inability of the primary caregiver to comply with home instructions
结局指标
主要结局
Analgesic Consumption
时间窗: 24 Hours
Number of doses of analgesics in the recovery room and in the first 24 hours at home
次要结局
- Postoperative Pain Scores(2 Weeks)
- Intraoperative opioid consumption(During Surgery)
- Time to place the block(During Surgery)
- Time to first analgesic request at home(2 Weeks)
- Block failure(2 Weeks)