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Study of Analgesic Efficacy of Nerve Blocks on Otoplastic Surgery

Primary Purpose

Microtia, Microtia, Congenital

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
intercostal nerve block under direct vision
intercostal nerve block under ultrasound guidance
paravertebral block under ultrasound guidance
Sponsored by
Eye & ENT Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Microtia focused on measuring intercostal nerve blocks, ultrasound guidance, thoracic paravertebral block, pain management

Eligibility Criteria

8 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Eye,Ear,Nose and throat Hospital ,Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

DV-ICNB group

UG-ICNB group

PV group

Arm Description

intercostal nerve block under direct vision

intercostal nerve block under ultrasound guidance

thoracic paravertebral block under ultrasound guidance

Outcomes

Primary Outcome Measures

Chest pain at rest
Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
Chest pain at rest
Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
Chest pain at rest
Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
Chest pain at rest
Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
Chest pain at rest
Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
Chest pain during deep breath
Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
Chest pain during deep breath
Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
Chest pain during deep breath
Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
Chest pain during deep breath
Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
Chest pain during deep breath
Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
Ear pain at rest
Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
Ear pain at rest
Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
Ear pain at rest
Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
Ear pain at rest
Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
Ear pain at rest
Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
Ear pain during deep breath
Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
Ear pain during deep breath
Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
Ear pain during deep breath
Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
Ear pain during deep breath
Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
Ear pain during deep breath
Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
PCIA consumption
Assessed by consumption of patient-controlled intravenous analgesia
PCIA consumption
Assessed by consumption of patient-controlled intravenous analgesia
PCIA consumption
Assessed by consumption of patient-controlled intravenous analgesia
PCIA consumption
Assessed by consumption of patient-controlled intravenous analgesia
Nausea severity
Assessed by Verbal Rating Scale(VRS),(0,no pain;10,the worst pain)
Nausea severity
Assessed by Verbal Rating Scale(VRS),(0,no pain;10,the worst pain)
Nausea severity
Assessed by Verbal Rating Scale(VRS),(0,no pain;10,the worst pain)
Nausea severity
Assessed by Verbal Rating Scale(VRS),(0,no pain;10,the worst pain)
Number of vomiting
Assessed by vomiting times after surgery
Number of vomiting
Assessed by vomiting times after surgery
Number of vomiting
Assessed by vomiting times after surgery
Number of vomiting
Assessed by vomiting times after surgery
Intraoperative fentanyl requirement
Assessed by total requirement of fentanyl( µg/kg) during the surgery

Secondary Outcome Measures

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
Assessed by the blood loss(ml) ) when surgeons are harvesting rib cartilage for auricular reconstruction
Fentanyl requirement in PACU
Assessed by total additional requirement of fentanyl for keeping VAS scores less than '5'

Full Information

First Posted
November 25, 2019
Last Updated
July 25, 2020
Sponsor
Eye & ENT Hospital of Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT04192708
Brief Title
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

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 17, 2020 (Actual)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
November 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eye & ENT Hospital of Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microtia, Microtia, Congenital
Keywords
intercostal nerve blocks, ultrasound guidance, thoracic paravertebral block, pain management

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DV-ICNB group
Arm Type
Experimental
Arm Description
intercostal nerve block under direct vision
Arm Title
UG-ICNB group
Arm Type
Experimental
Arm Description
intercostal nerve block under ultrasound guidance
Arm Title
PV group
Arm Type
Experimental
Arm Description
thoracic paravertebral block under ultrasound guidance
Intervention Type
Procedure
Intervention Name(s)
intercostal nerve block under direct vision
Intervention Description
When the intercostal nerve is adequated exposed,a surgeon use a 5ml syringe to perform the block and the needle is tilted 15 degree cephalad and advanced towards the caudal rim of the lib,and penetration depth is about 5mm.Then 1% lidocaine and 1/200000 epinephrine 3ml will be injected when negative aspiration of gas or blood.Same procedure will be repeted in the other two exposed intercostal spaces.
Intervention Type
Procedure
Intervention Name(s)
intercostal nerve block under ultrasound guidance
Intervention Description
After induction ,an ultrasonographic probe (M-Turbo with the L25 transducer; SonoSite Inc.) is used to scan laterally from the midaxillary line to identify the required anatomic landmarks, while the patients are in a lateral decubitus position. The ribs are identified as hyperechoic streaks, while the pleura appeared as hyperechoic lines between and below the ribs.The needle was advanced towards the caudal rim of the rib until the distal tip is just between the innermost and inner intercostal muscle.1% lidocaine and 1/200000 epinephrine 3ml will be injected when negative aspiration of gas or blood.Same procedure will be repeted in the other two exposed intercostal spaces.
Intervention Type
Procedure
Intervention Name(s)
paravertebral block under ultrasound guidance
Intervention Description
Paravertebral block is performed between the thoracic segments T7-8,A linear ultrasound transducer (M-Turbo with the L25×transducer; SonoSite Inc.) is placed to parallel the T7 transverse process so as to identify the T7 spinous process,the T7 transverse process and 7th lib.Then move the probe caudally until the thoracic paravertebral space (TPVS) which is bounded by transverse process,pleura and internal intercostal membrane.Using in-plane technique, we advance the 20-gauge needle(Becton Dickinson Infusion Therapy Sysstems Inc.Sandy,Utah 84070,USA.1.88",1.1×48mm) until the needle tip penetrates the internal intercostal membrane,9ml mixture of 1% lidocaine and 1/200000 epinephrine after no blood or gas is aspirated.Both PVB and ultrasound-guided ICNB is performed by the same anesthesiologist
Primary Outcome Measure Information:
Title
Chest pain at rest
Description
Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
Time Frame
Time1:0 minute after the first pain score could be obtained from the patient
Title
Chest pain at rest
Description
Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
Time Frame
Time2: 3 hours after surgery
Title
Chest pain at rest
Description
Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
Time Frame
Time3: 6 hours after surgery
Title
Chest pain at rest
Description
Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
Time Frame
Time4: 24 hours after surgery
Title
Chest pain at rest
Description
Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
Time Frame
Time5: 48 hours after surgery
Title
Chest pain during deep breath
Description
Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
Time Frame
Time1:0 minute after the first pain score could be obtained from the patient
Title
Chest pain during deep breath
Description
Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
Time Frame
Time2: 3 hours after surgery
Title
Chest pain during deep breath
Description
Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
Time Frame
Time3: 6 hours after surgery
Title
Chest pain during deep breath
Description
Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
Time Frame
Time4: 24 hours after surgery
Title
Chest pain during deep breath
Description
Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
Time Frame
Time5: 48 hours after surgery
Title
Ear pain at rest
Description
Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
Time Frame
Time1:0 minute after the first pain score could be obtained from the patient
Title
Ear pain at rest
Description
Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
Time Frame
Time2: 3 hours after surgery
Title
Ear pain at rest
Description
Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
Time Frame
Time3: 6 hours after surgery
Title
Ear pain at rest
Description
Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
Time Frame
Time4: 24 hours after surgery
Title
Ear pain at rest
Description
Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
Time Frame
Time5: 48 hours after surgery
Title
Ear pain during deep breath
Description
Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
Time Frame
Time1:0 minute after the first pain score could be obtained from the patient
Title
Ear pain during deep breath
Description
Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
Time Frame
Time2: 3 hours after surgery
Title
Ear pain during deep breath
Description
Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
Time Frame
Time3: 6 hours after surgery
Title
Ear pain during deep breath
Description
Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
Time Frame
Time4: 24 hours after surgery
Title
Ear pain during deep breath
Description
Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
Time Frame
Time5: 48 hours after surgery
Title
PCIA consumption
Description
Assessed by consumption of patient-controlled intravenous analgesia
Time Frame
Time1:3 hours after surgery
Title
PCIA consumption
Description
Assessed by consumption of patient-controlled intravenous analgesia
Time Frame
Time2:6 hours after surgery
Title
PCIA consumption
Description
Assessed by consumption of patient-controlled intravenous analgesia
Time Frame
Time3:24 hours after surgery
Title
PCIA consumption
Description
Assessed by consumption of patient-controlled intravenous analgesia
Time Frame
Time4:48 hours after surgery
Title
Nausea severity
Description
Assessed by Verbal Rating Scale(VRS),(0,no pain;10,the worst pain)
Time Frame
Time1:3 hours after surgery
Title
Nausea severity
Description
Assessed by Verbal Rating Scale(VRS),(0,no pain;10,the worst pain)
Time Frame
Time2:6 hours after surgery
Title
Nausea severity
Description
Assessed by Verbal Rating Scale(VRS),(0,no pain;10,the worst pain)
Time Frame
Time3:24 hours after surgery
Title
Nausea severity
Description
Assessed by Verbal Rating Scale(VRS),(0,no pain;10,the worst pain)
Time Frame
Time4:48 hours after surgery
Title
Number of vomiting
Description
Assessed by vomiting times after surgery
Time Frame
Time1:3 hours after surgery
Title
Number of vomiting
Description
Assessed by vomiting times after surgery
Time Frame
Time2:6 hours after surgery
Title
Number of vomiting
Description
Assessed by vomiting times after surgery
Time Frame
Time3:24 hours after surgery
Title
Number of vomiting
Description
Assessed by vomiting times after surgery
Time Frame
Time4:48 hours after surgery
Title
Intraoperative fentanyl requirement
Description
Assessed by total requirement of fentanyl( µg/kg) during the surgery
Time Frame
Time1:0 minute after surgery
Secondary Outcome Measure Information:
Title
The first time of urination
Description
Assessed by the duration(hour) between end of surgery and the first time of urination
Time Frame
Time1:0 minute after the first time of urination
Title
Blood loss during harvesting rib cartilage
Description
Assessed by the blood loss(ml) ) when surgeons are harvesting rib cartilage for auricular reconstruction
Time Frame
Time1:0 minute after all three rib cartilage are harvested
Title
Fentanyl requirement in PACU
Description
Assessed by total additional requirement of fentanyl for keeping VAS scores less than '5'
Time Frame
Time1:0 minute after departure from the PACU

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of microtia Scheduled for rib cartilage harvest from three ribs for auricular reconstruction. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jie Jia, Master
Phone
8613641839213
Email
jiajie@eentanesthesia.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiao Hu, Master
Phone
8613816780317
Email
fibrescope@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiao Hu, Master
Organizational Affiliation
Eye and ENT Hospital of Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Eye,Ear,Nose and throat Hospital ,Fudan University
City
Shanghai
ZIP/Postal Code
200031
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiao Hu, Master
Phone
8613816780317
Email
fibrescope@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
8337267
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.
Results Reference
background
PubMed Identifier
24314181
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.
Results Reference
background
PubMed Identifier
25487477
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.
Results Reference
background
PubMed Identifier
15923270
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.
Results Reference
background
PubMed Identifier
23806943
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.
Results Reference
background

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Study of Analgesic Efficacy of Nerve Blocks on Otoplastic Surgery

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