Microtia Clinical Trial
Official title:
Study of Analgesic Efficacy of Different Kinds of Nerve Blocks on Otoplastic Surgery
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.
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 .
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