Study of Analgesic Efficacy of Nerve Blocks on Otoplastic Surgery
- Conditions
- MicrotiaMicrotia, Congenital
- Interventions
- Procedure: intercostal nerve block under direct visionProcedure: intercostal nerve block under ultrasound guidanceProcedure: paravertebral block under ultrasound guidance
- Registration Number
- NCT04192708
- Lead Sponsor
- Eye & ENT Hospital of Fudan University
- Brief Summary
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.
- Detailed Description
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 .
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 144
- Clinical diagnosis of microtia
- Scheduled for rib cartilage harvest from three ribs for auricular reconstruction.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DV-ICNB group intercostal nerve block under direct vision intercostal nerve block under direct vision UG-ICNB group intercostal nerve block under ultrasound guidance intercostal nerve block under ultrasound guidance PV group paravertebral block under ultrasound guidance thoracic paravertebral block under ultrasound guidance
- Primary Outcome Measures
Name Time Method Chest pain at rest Time5: 48 hours after surgery Assessed by Visual Analogue Scale（VAS）,(0,no pain；10，the worst pain)
Ear pain during deep breath Time5: 48 hours after surgery Assessed by Visual Analogue Scale（VAS）,(0,no pain；10，the worst pain)
Nausea severity Time4:48 hours after surgery Assessed by Verbal Rating Scale（VRS）,(0,no pain；10，the worst pain)
Chest pain during deep breath Time5: 48 hours after surgery Assessed by Visual Analogue Scale（VAS）,(0,no pain；10，the worst pain)
Ear pain at rest Time5: 48 hours after surgery Assessed by Visual Analogue Scale（VAS）,(0,no pain；10，the worst pain)
PCIA consumption Time4:48 hours after surgery Assessed by consumption of patient-controlled intravenous analgesia
Number of vomiting Time4:48 hours after surgery Assessed by vomiting times after surgery
Intraoperative fentanyl requirement Time1:0 minute after surgery Assessed by total requirement of fentanyl( µg/kg) during the surgery
- Secondary Outcome Measures
Name Time Method The first time of urination Time1:0 minute after the first time of urination Assessed by the duration(hour) between end of surgery and the first time of urination
Blood loss during harvesting rib cartilage Time1:0 minute after all three rib cartilage are harvested Assessed by the blood loss(ml)
) when surgeons are harvesting rib cartilage for auricular reconstructionFentanyl requirement in PACU Time1:0 minute after departure from the PACU Assessed by total additional requirement of fentanyl for keeping VAS scores less than '5'
Trial Locations
- Locations (1)
The Eye,Ear,Nose and throat Hospital ,Fudan University
🇨🇳Shanghai, China