Bilateral Paravertebral Blockade (T7-10) vs. Incisional Local Anesthetic Administration for Laparoscopic Cholecystectomy: a Prospective, Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Opioids Consumption Via PCA
研究概览
简要总结
The objective of this study is to assess the efficacy of paravertebral nerve blocks, single shot, with ropivacaine 0.5% for postoperative pain control after elective laparoscopic cholecystectomy as compared with incisional administration of same local anesthetic at laparoscopic insufflation ports by the surgeon.
详细描述
Pain after laparoscopic cholecystectomy is a result of many mechanisms such as tissue injury, local trauma to gallbladder removal, chemical irritation of the peritoneum, pneumoperitoneum. Effective analgesia in the immediate post-operative period following laparoscopic cholecystectomy is necessary for optimal recovery. Many methods for pain control after laparoscopic cholecystectomy have been evaluated, but none of them provided optimal postoperative analgesia. When used as a complement to general anesthesia, bilateral paravertebral blockade T5-T6 for adult laparoscopic cholecystectomy has been found to improve postoperative pain control. Whether this is also the case with pediatric patients is not certain. Analgesia from administration of local anesthetic by surgeon at insufflations ports is of short duration and may not provide sufficient pain relief. cholecystectomy.
84 pediatric patients (8-17 yrs old) will be randomly assigned to two groups: Group 1 (treatment group): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5%, and incisional administration of placebo / normal saline at all four laparoscopic ports.
Group 2 (control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all for insufflation ports with ropivacaine 0.5%.
Both the anesthesiologist and the surgeon will be blinded to patient randomization.
Additional postoperative pain control will be provided via patient administered dilaudid PCA, for 12 hours after paravertebral block. After PCA is discontinued, the patient will receive oxycodone po and dilaudid iv for breakthrough pain.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •pediatric patients scheduled for elective laparoscopic cholecystectomy under general anesthesia
- •8-17 yrs, female and male
- •ASA 1, 2, 3
- •more than 30 Kg
- •BMI less than 36 (to calculate will use http://www.globalrph.com/bmi.htm )
- •the patient must be able to self administer opioids via patient control analgesia (PCA)
- •the patient must be able to complete postoperative questionnaires for pain score, pain type, location, patient satisfaction
- •the patient will to be admitted for 24 hrs after surgery
排除标准
- •patient refusal
- •parental/guardian refusal
- •history of coagulopathy, INR more than 1.5, platelets less than 100 000, PT , PTT more than normal value, patient on Coumadin, heparin or low molecular weight heparin ( LMWH)
- •local infection at the planned block site
- •vertebral anomalies, (e.g. scoliosis)
- •BMI more or equal 36
- •patient unable to self administer medications via PCA
- •allergy to dilaudid, oxycodone, acetaminophen, ropivacaine
- •chronic opioid use
- •current weight less than 30 kg
- •acute pain (pain on day of surgery that requires pain medication)
- •pregnancy test positive
研究组 & 干预措施
treatment group
Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.
干预措施: treatment group (Drug)
Placebo group
Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.
干预措施: control group (Drug)
结局指标
主要结局
Opioids Consumption Via PCA
时间窗: 12 hrs after the blocks were done
The primary end-point of this research is the amount of dilaudid (ng/kg/min) administered via Patient Controlled Analgesia (PCA), 12 hours after administration of ropivacaine 0.5% /normal saline in paravertebral space and administration of normal saline/ropivacaine 0.5% at all four laparoscopic ports.
次要结局
- Postoperative Pain Scores Assessed Using Visual Analog Scale (VAS).(24 hrs after blocks were done or until the patient is discharged)
- Opioid Consumption(24 hrs after blocks were done or until the patient is discharged)
研究者
Mihaela Visoiu
Clinical Assistant Professor
University of Pittsburgh