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.
Status | Recruiting |
Enrollment | 144 |
Est. completion date | November 2020 |
Est. primary completion date | September 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years to 16 Years |
Eligibility |
Inclusion Criteria: 1. Clinical diagnosis of microtia 2. Scheduled for rib cartilage harvest from three ribs for auricular reconstruction. Exclusion Criteria: 1. Requirement for additional surgery 2. Rib cartilage harvest from more or less than three ribs 3. 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. |
Country | Name | City | State |
---|---|---|---|
China | The Eye,Ear,Nose and throat Hospital ,Fudan University | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Eye & ENT Hospital of Fudan University |
China,
Lukosiene L, Macas A, Trepenaitis D, Kalibatiene L, Malcius D, Barauskas V. Single shot intercostal block for pain management in pediatric patients undergoing the Nuss procedure: a double-blind, randomized, controlled study. J Pediatr Surg. 2014 Dec;49(12):1753-7. doi: 10.1016/j.jpedsurg.2014.09.014. Epub 2014 Oct 1. — View Citation
Lukosiene L, Rugyte DC, Macas A, Kalibatiene L, Malcius D, Barauskas V. Postoperative pain management in pediatric patients undergoing minimally invasive repair of pectus excavatum: the role of intercostal block. J Pediatr Surg. 2013 Dec;48(12):2425-30. doi: 10.1016/j.jpedsurg.2013.08.016. — View Citation
Nagata S. A new method of total reconstruction of the auricle for microtia. Plast Reconstr Surg. 1993 Aug;92(2):187-201. — View Citation
Vemula R, Kutzin M, Greco G, Kutzin T. The use of intercostal nerve blocks for implant-based breast surgery. Plast Reconstr Surg. 2013 Jul;132(1):178e-80e. doi: 10.1097/PRS.0b013e3182911018. — View Citation
Willschke H, Marhofer P, Bösenberg A, Johnston S, Wanzel O, Cox SG, Sitzwohl C, Kapral S. Ultrasonography for ilioinguinal/iliohypogastric nerve blocks in children. Br J Anaesth. 2005 Aug;95(2):226-30. Epub 2005 May 27. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Chest pain at rest | Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain) | Time1:0 minute after the first pain score could be obtained from the patient | |
Primary | Chest pain at rest | Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain) | Time2: 3 hours after surgery | |
Primary | Chest pain at rest | Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain) | Time3: 6 hours after surgery | |
Primary | Chest pain at rest | Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain) | Time4: 24 hours after surgery | |
Primary | Chest pain at rest | Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain) | Time5: 48 hours after surgery | |
Primary | Chest pain during deep breath | Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain) | Time1:0 minute after the first pain score could be obtained from the patient | |
Primary | Chest pain during deep breath | Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain) | Time2: 3 hours after surgery | |
Primary | Chest pain during deep breath | Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain) | Time3: 6 hours after surgery | |
Primary | Chest pain during deep breath | Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain) | Time4: 24 hours after surgery | |
Primary | Chest pain during deep breath | Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain) | Time5: 48 hours after surgery | |
Primary | Ear pain at rest | Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain) | Time1:0 minute after the first pain score could be obtained from the patient | |
Primary | Ear pain at rest | Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain) | Time2: 3 hours after surgery | |
Primary | Ear pain at rest | Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain) | Time3: 6 hours after surgery | |
Primary | Ear pain at rest | Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain) | Time4: 24 hours after surgery | |
Primary | Ear pain at rest | Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain) | Time5: 48 hours after surgery | |
Primary | Ear pain during deep breath | Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain) | Time1:0 minute after the first pain score could be obtained from the patient | |
Primary | Ear pain during deep breath | Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain) | Time2: 3 hours after surgery | |
Primary | Ear pain during deep breath | Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain) | Time3: 6 hours after surgery | |
Primary | Ear pain during deep breath | Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain) | Time4: 24 hours after surgery | |
Primary | Ear pain during deep breath | Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain) | Time5: 48 hours after surgery | |
Primary | PCIA consumption | Assessed by consumption of patient-controlled intravenous analgesia | Time1:3 hours after surgery | |
Primary | PCIA consumption | Assessed by consumption of patient-controlled intravenous analgesia | Time2:6 hours after surgery | |
Primary | PCIA consumption | Assessed by consumption of patient-controlled intravenous analgesia | Time3:24 hours after surgery | |
Primary | PCIA consumption | Assessed by consumption of patient-controlled intravenous analgesia | Time4:48 hours after surgery | |
Primary | Nausea severity | Assessed by Verbal Rating Scale(VRS),(0,no pain;10,the worst pain) | Time1:3 hours after surgery | |
Primary | Nausea severity | Assessed by Verbal Rating Scale(VRS),(0,no pain;10,the worst pain) | Time2:6 hours after surgery | |
Primary | Nausea severity | Assessed by Verbal Rating Scale(VRS),(0,no pain;10,the worst pain) | Time3:24 hours after surgery | |
Primary | Nausea severity | Assessed by Verbal Rating Scale(VRS),(0,no pain;10,the worst pain) | Time4:48 hours after surgery | |
Primary | Number of vomiting | Assessed by vomiting times after surgery | Time1:3 hours after surgery | |
Primary | Number of vomiting | Assessed by vomiting times after surgery | Time2:6 hours after surgery | |
Primary | Number of vomiting | Assessed by vomiting times after surgery | Time3:24 hours after surgery | |
Primary | Number of vomiting | Assessed by vomiting times after surgery | Time4:48 hours after surgery | |
Primary | Intraoperative fentanyl requirement | Assessed by total requirement of fentanyl( µg/kg) during the surgery | Time1:0 minute after surgery | |
Secondary | The first time of urination | Assessed by the duration(hour) between end of surgery and the first time of urination | Time1:0 minute after the first time of urination | |
Secondary | Blood loss during harvesting rib cartilage | Assessed by the blood loss(ml) ) when surgeons are harvesting rib cartilage for auricular reconstruction |
Time1:0 minute after all three rib cartilage are harvested | |
Secondary | Fentanyl requirement in PACU | Assessed by total additional requirement of fentanyl for keeping VAS scores less than '5' | Time1:0 minute after departure from the PACU |
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