Clinical trial NCT04192708: Study of Analgesic Efficacy of Nerve Blocks on Otoplastic Surgery
Official title: Study of Analgesic Efficacy of Different Kinds of Nerve Blocks on Otoplastic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Microtia
Microtia, Congenital
Keywords: intercostal nerve blocks
ultrasound guidance
thoracic paravertebral block
pain management
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 144
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 .

Eligibility criteria: 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.

Primary outcomes:
measure: Chest pain at rest
timeFrame: Time1:0 minute after the first pain score could be obtained from the patient
measure: Chest pain at rest
timeFrame: Time2: 3 hours after surgery
measure: Chest pain at rest
timeFrame: Time3: 6 hours after surgery
measure: Chest pain at rest
timeFrame: Time4: 24 hours after surgery
measure: Chest pain at rest
timeFrame: Time5: 48 hours after surgery
measure: Chest pain during deep breath
timeFrame: Time1:0 minute after the first pain score could be obtained from the patient
measure: Chest pain during deep breath
timeFrame: Time2: 3 hours after surgery
measure: Chest pain during deep breath
timeFrame: Time3: 6 hours after surgery
measure: Chest pain during deep breath
timeFrame: Time4: 24 hours after surgery
measure: Chest pain during deep breath
timeFrame: Time5: 48 hours after surgery
measure: Ear pain at rest
timeFrame: Time1:0 minute after the first pain score could be obtained from the patient
measure: Ear pain at rest
timeFrame: Time2: 3 hours after surgery
measure: Ear pain at rest
timeFrame: Time3: 6 hours after surgery
measure: Ear pain at rest
timeFrame: Time4: 24 hours after surgery
measure: Ear pain at rest
timeFrame: Time5: 48 hours after surgery
measure: Ear pain during deep breath
timeFrame: Time1:0 minute after the first pain score could be obtained from the patient
measure: Ear pain during deep breath
timeFrame: Time2: 3 hours after surgery
measure: Ear pain during deep breath
timeFrame: Time3: 6 hours after surgery
measure: Ear pain during deep breath
timeFrame: Time4: 24 hours after surgery
measure: Ear pain during deep breath
timeFrame: Time5: 48 hours after surgery
measure: PCIA consumption
timeFrame: Time1:3 hours after surgery
measure: PCIA consumption
timeFrame: Time2:6 hours after surgery
measure: PCIA consumption
timeFrame: Time3:24 hours after surgery
measure: PCIA consumption
timeFrame: Time4:48 hours after surgery
measure: Nausea severity
timeFrame: Time1:3 hours after surgery
measure: Nausea severity
timeFrame: Time2:6 hours after surgery
measure: Nausea severity
timeFrame: Time3:24 hours after surgery
measure: Nausea severity
timeFrame: Time4:48 hours after surgery
measure: Number of vomiting
timeFrame: Time1:3 hours after surgery
measure: Number of vomiting
timeFrame: Time2:6 hours after surgery
measure: Number of vomiting
timeFrame: Time3:24 hours after surgery
measure: Number of vomiting
timeFrame: Time4:48 hours after surgery
measure: Intraoperative fentanyl requirement
timeFrame: Time1:0 minute after surgery
Secondary outcomes:
measure: The first time of urination
timeFrame: Time1:0 minute after the first time of urination
measure: Blood loss during harvesting rib cartilage
timeFrame: Time1:0 minute after all three rib cartilage are harvested
measure: Fentanyl requirement in PACU
timeFrame: Time1:0 minute after departure from the PACU
Other outcomes:
Locations:
city: Shanghai
country: China
facility: The Eye,Ear,Nose and throat Hospital ,Fudan University
Study officials:
affiliation: Eye and ENT Hospital of Fudan University
name: Xiao Hu, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nagata S. A new method of total reconstruction of the auricle for microtia. Plast Reconstr Surg. 1993 Aug;92(2):187-201. doi: 10.1097/00006534-199308000-00001.
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.
citation: 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.
citation: Willschke H, Marhofer P, Bosenberg 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. doi: 10.1093/bja/aei157. Epub 2005 May 27.
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-180e. doi: 10.1097/PRS.0b013e3182911018. No abstract available.