Study of Analgesic Efficacy of Different Kinds of Nerve Blocks on Otoplastic Surgery
试验速览
- 阶段
- 4 期
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Chest pain at rest
研究概览
简要总结
Background: Children with microtia complain of severe postoperative pain during early postoperative days after rib cartilage harvest for auricular reconstruction. The purpose of this study was to compare the analgesic efficacy of intercostal nerve block (ICNB) and paravertebral block(PV) for preventing postoperative pain after rib cartilage graft for auricular reconstruction in children with microtia.
Methods: In this prospective randomized study, 144 children will be enrolled in this study and randomized into 3 groups:48 patients will received ultrasound-guided ICNB(UG-ICNB group);48 patients will receive ICNB under direct vision (DV-ICNB group) and 48 patients will receive paravertebral block(PV group) undergoing postoperative pain control using either preventive ICNB followed by catheter-based infusion (33 patients, study group) or intravenous (IV) analgesia alone (33 patients, control group). ICNB will be performed by injecting 1% lidocaine plus 1/200000 epinephrine 3ml into each of three intercostal spaces before perichondrial dissection. PV will be carried out by injecting 1% lidocaine plus 1/200000 epinephrine 9ml into T7 paravertebral space just after induction of anesthesia.before wound closure.Each patient receive patient-controlled intravenous analgesia(PCIA) after surgery.Severity of pain,nausea,vomiting and other side effects would be assessed for the postoperative period of 48 hours.
详细描述
Patients are randomly allocated to one of three groups: receiving intercostal nerve block under direct vision (DV-ICNB group) or receiving intercostal nerve block under ultrasound guidance (UG-ICNB group) or receiving thoracic paravertebral block (PV group) with a block of 6 and 1:1 allocation ratio. . Enrolment and data collection are performed by trained research staff who are not involved in the care of the patients. The treating clinicians are not blinded to the assignment group, but all other staff involved in both the collection and assessment of data are blinded to group allocation.
The primary outcomes is the pain severity,intraoperative fentanyl consumption ,patient-controlled intravenous analgesia(PCIA) requirement and severity of nausea and vomiting during the period of postoperative 48 hours. The secondary outcomes are blood loss during harvesting rib cartilage,fentanyl consumption in post-anaesthesia care unit (PACU),time from PACU arrival to first obtainable pain score,first time of urination,duration of PACU stay and postoperative adverse events such as respiratory depression(defined as respiratory rate <8bpm, requirement of naloxone, and/or peripheral oxygen saturation <90%),pneumothorax and pruritus.
Based on our previous clinical observation, 2.7(SD 0.5)μg/kg of fentanyl is required in DV-ICNB group.We suppose that the requirement could be reduce by 0.3μg/kg in UG-ICNB and PV group .Thus,42 patients are required to detect a significant difference among the groups at a significance level of 95% and a power of 80%. 20 patients were finally enrolled in the study due to possible dropouts (20%).
The continuous variables were expressed as means ± standard deviation (SD) whereas categorical variables were expressed as frequency and percentage for data description. Continous data with a normal distribution is manifested as mean±SD and assessed by Unpaired sample t-test ;continous data with skewed distribution is presented as median(interquartile range,IQR) and assessed by Man-Whitney U test ;categorical data are presented as number and assessed by Chi-square/Fisher exact test. The VAS scores,PCIA consumption and severity of nausea and vomiting of the three groups at multiple time points were analyzed via two-way repeated-measures Anova .
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 16 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of microtia
- •Scheduled for rib cartilage harvest from three ribs for auricular reconstruction.
排除标准
- •Requirement for additional surgery
- •Rib cartilage harvest from more or less than three ribs
- •History of analgesic administration (eg, opioids, acetaminophen, or 4.Nonsteroidal anti-inflammatory drugs) 24 hours before premedication
- •5.History of coagulation disorders or allergy to local anesthetics 6.History of renal insufficiency or an American Society of Anesthesiologists (ASA) physical status that was higher than II 7.Inability to express pain scores or severity of nausea 8.Inability to understand PCIA device use 9.Parental objection to ICNBs or paravertebral block.
结局指标
主要结局
Chest pain at rest
时间窗: Time5: 48 hours after surgery
Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
Ear pain during deep breath
时间窗: Time5: 48 hours after surgery
Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
Nausea severity
时间窗: Time4:48 hours after surgery
Assessed by Verbal Rating Scale(VRS),(0,no pain;10,the worst pain)
Chest pain during deep breath
时间窗: Time5: 48 hours after surgery
Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
Ear pain at rest
时间窗: Time5: 48 hours after surgery
Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
PCIA consumption
时间窗: Time4:48 hours after surgery
Assessed by consumption of patient-controlled intravenous analgesia
Number of vomiting
时间窗: Time4:48 hours after surgery
Assessed by vomiting times after surgery
Intraoperative fentanyl requirement
时间窗: Time1:0 minute after surgery
Assessed by total requirement of fentanyl( µg/kg) during the surgery
次要结局
- Fentanyl requirement in PACU(Time1:0 minute after departure from the PACU)
- The first time of urination(Time1:0 minute after the first time of urination)
- Blood loss during harvesting rib cartilage(Time1:0 minute after all three rib cartilage are harvested)
研究者
Xiao Hu
The attentding physician of Department of Anesthesiology
Eye & ENT Hospital of Fudan University
