The Efficacy and Safety of Local Anesthetic Infusion With Ropivacaine for the Management of Pain After Surgical Correction of Ureteropelvic Junction Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Morphine
研究概览
简要总结
The investigators propose a prospective blinded randomized control trial (RCT) to assess the efficacy and safety of a simple method of continuous infusion of a local anesthetic, ropivacaine, via a surgical wound to control pain after ureteropelvic junction (UPJ) stenosis correction in children during the first 48 hrs after surgery. The investigators hypothesize that this technique will provide greater pain relief post-operatively and reduce the need for systemic opioid use along with a reduction in associated side effects of such analgesics.
详细描述
The investigators hypothesize that continuous infusion of local anesthetic via a wound catheter would improve postoperative pain control after UPJ correction and diminish the adverse effects associated with current use of opioids, administered via epidural or systemic route, for the management of postoperative pain. The expected benefits from wound catheter infusion are reduction in postoperative opioids requirement thereby diminishing the associated side effects of sedation, respiratory depression, nausea, vomiting, and ileus which occur at an average rate of 50% in children and adolescents based on recent meta-analysis. It may also facilitate early oral intake, ambulation and early discharge from the hospital.
The current use of epidural indwelling catheters for analgesia is associated with 20-25% technical failure rate from catheter misplacement, occlusion, disconnect or dislodgement, premature discontinuation of analgesia due to opioid-related side effects, requires bladder catheterization, and local anesthetic induced weakness in the lower extremities that usually delays ambulation. The dose of local anesthetics infused via the epidural route is much larger than proposed via wound catheters and carries greater risks of systemic toxicity compared to infusion doses anticipated via wound catheter infusion. In addition, the use of opioids such as morphine or hydromorphone via the epidural indwelling catheters produce adverse effects similar to that of systemic opioids and require electronic and close nursing monitoring.
Study Design
The study will include patients, male and female, between the ages of 3 months to 14 years of all ethnic and race groups. Patients with a history of clinically significant cardiovascular, pulmonary, hepatic, renal, neurologic, psychiatric or metabolic disease will be excluded. After obtaining consent from a legal guardian, patients will be randomly assigned to the placebo or treatment group. Both groups will receive rescue opioids for postoperative pain management via either patient-controlled analgesia (PCA) or nurse-controlled analgesia (NCA) administration for younger patients. The intraoperative anesthetic management will be standardized in all patients.
The wound catheter (Soaker multi-orifice catheter approved by the FDA) will be placed at the completion of the surgery in the subcutaneous space parallel and proximal to the surgical incision by the surgeon. The Pain Treatment Service will manage postoperative pain with standardized protocols including infusion of ropivacaine via the wound catheter and administration of rescue opioids via PCA/NCA. Patients will be randomly assigned to receive infusions of either ropivacaine or saline via the wound catheters.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 3 Months 至 14 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of UPJ stenosis requiring surgical repair
- •Ages 3 months to 14 years old
- •Guardians give consent and the child gives assent when appropriate
- •Both genders
- •All racial and ethnic groups
排除标准
- •A history of chronic pain and/or use of chronic opioids and other analgesic(s)
- •If parents/patients or attending urologist request epidural analgesia or refuse to participate in the study
- •Impairment of cognition/neurologic, hepatic, renal, cardiovascular, endocrine, metabolic, and/or coagulation function
- •A history of any diagnosis of psychiatric disorders, including bipolar disorders by self-report or by guardian
- •A recent history of illicit chemical abuse within one week prior to surgical date
- •Participants known to be taking prescribed medications or over-the-counter medications known to affect pain perception such as central nervous system stimulants, hypnotics, sedatives, etc within 24 hours of planned surgical procedure
结局指标
主要结局
Morphine
时间窗: 48 hours
Total amount of morphine used in the first 48hrs immediately after surgery
次要结局
- FLACC Pain Intensity [Faces Legs Activity Cry Consolability] 0-10 Points(48 hours post-operatively)
研究者
Navil Sethna
Senior Associate in Perioperative Anesthesia
Boston Children's Hospital
