NCT04192708

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
144

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2020

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 10, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

February 17, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

July 28, 2020

Status Verified

July 1, 2020

Enrollment Period

7 months

First QC Date

November 25, 2019

Last Update Submit

July 25, 2020

Conditions

MicrotiaMicrotia, Congenital

Keywords

intercostal nerve blocksultrasound guidancethoracic paravertebral blockpain management

Outcome Measures

Primary Outcomes (33)

  • 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

  • Chest pain at rest

    Assessed by Visual Analogue Scale（VAS）,(0,no pain；10，the worst pain)

    Time2: 3 hours after surgery

  • Chest pain at rest

    Assessed by Visual Analogue Scale（VAS）,(0,no pain；10，the worst pain)

    Time3: 6 hours after surgery

  • Chest pain at rest

    Assessed by Visual Analogue Scale（VAS）,(0,no pain；10，the worst pain)

    Time4: 24 hours after surgery

  • Chest pain at rest

    Assessed by Visual Analogue Scale（VAS）,(0,no pain；10，the worst pain)

    Time5: 48 hours after surgery

  • 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

  • Chest pain during deep breath

    Assessed by Visual Analogue Scale（VAS）,(0,no pain；10，the worst pain)

    Time2: 3 hours after surgery

  • Chest pain during deep breath

    Assessed by Visual Analogue Scale（VAS）,(0,no pain；10，the worst pain)

    Time3: 6 hours after surgery

  • Chest pain during deep breath

    Assessed by Visual Analogue Scale（VAS）,(0,no pain；10，the worst pain)

    Time4: 24 hours after surgery

  • Chest pain during deep breath

    Assessed by Visual Analogue Scale（VAS）,(0,no pain；10，the worst pain)

    Time5: 48 hours after surgery

  • 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

  • Ear pain at rest

    Assessed by Visual Analogue Scale（VAS）,(0,no pain；10，the worst pain)

    Time2: 3 hours after surgery

  • Ear pain at rest

    Assessed by Visual Analogue Scale（VAS）,(0,no pain；10，the worst pain)

    Time3: 6 hours after surgery

  • Ear pain at rest

    Assessed by Visual Analogue Scale（VAS）,(0,no pain；10，the worst pain)

    Time4: 24 hours after surgery

  • Ear pain at rest

    Assessed by Visual Analogue Scale（VAS）,(0,no pain；10，the worst pain)

    Time5: 48 hours after surgery

  • 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

  • Ear pain during deep breath

    Assessed by Visual Analogue Scale（VAS）,(0,no pain；10，the worst pain)

    Time2: 3 hours after surgery

  • Ear pain during deep breath

    Assessed by Visual Analogue Scale（VAS）,(0,no pain；10，the worst pain)

    Time3: 6 hours after surgery

  • Ear pain during deep breath

    Assessed by Visual Analogue Scale（VAS）,(0,no pain；10，the worst pain)

    Time4: 24 hours after surgery

  • Ear pain during deep breath

    Assessed by Visual Analogue Scale（VAS）,(0,no pain；10，the worst pain)

    Time5: 48 hours after surgery

  • PCIA consumption

    Assessed by consumption of patient-controlled intravenous analgesia

    Time1:3 hours after surgery

  • PCIA consumption

    Assessed by consumption of patient-controlled intravenous analgesia

    Time2:6 hours after surgery

  • PCIA consumption

    Assessed by consumption of patient-controlled intravenous analgesia

    Time3:24 hours after surgery

  • PCIA consumption

    Assessed by consumption of patient-controlled intravenous analgesia

    Time4:48 hours after surgery

  • Nausea severity

    Assessed by Verbal Rating Scale（VRS）,(0,no pain；10，the worst pain)

    Time1:3 hours after surgery

  • Nausea severity

    Assessed by Verbal Rating Scale（VRS）,(0,no pain；10，the worst pain)

    Time2:6 hours after surgery

  • Nausea severity

    Assessed by Verbal Rating Scale（VRS）,(0,no pain；10，the worst pain)

    Time3:24 hours after surgery

  • Nausea severity

    Assessed by Verbal Rating Scale（VRS）,(0,no pain；10，the worst pain)

    Time4:48 hours after surgery

  • Number of vomiting

    Assessed by vomiting times after surgery

    Time1:3 hours after surgery

  • Number of vomiting

    Assessed by vomiting times after surgery

    Time2:6 hours after surgery

  • Number of vomiting

    Assessed by vomiting times after surgery

    Time3:24 hours after surgery

  • Number of vomiting

    Assessed by vomiting times after surgery

    Time4:48 hours after surgery

  • Intraoperative fentanyl requirement

    Assessed by total requirement of fentanyl( µg/kg) during the surgery

    Time1:0 minute after surgery

Secondary Outcomes (3)

  • The first time of urination

    Time1:0 minute after the first time of urination

  • Blood loss during harvesting rib cartilage

    Time1:0 minute after all three rib cartilage are harvested

  • Fentanyl requirement in PACU

    Time1:0 minute after departure from the PACU

Study Arms (3)

DV-ICNB group

EXPERIMENTAL

intercostal nerve block under direct vision

Procedure: intercostal nerve block under direct vision

UG-ICNB group

EXPERIMENTAL

intercostal nerve block under ultrasound guidance

Procedure: intercostal nerve block under ultrasound guidance

PV group

EXPERIMENTAL

thoracic paravertebral block under ultrasound guidance

Procedure: paravertebral block under ultrasound guidance

Interventions

intercostal nerve block under direct visionPROCEDURE

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.

DV-ICNB group
intercostal nerve block under ultrasound guidancePROCEDURE

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.

UG-ICNB group
paravertebral block under ultrasound guidancePROCEDURE

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

PV group

Eligibility Criteria

Age8 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Clinical diagnosis of microtia
  • Scheduled for rib cartilage harvest from three ribs for auricular reconstruction.

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Eye,Ear,Nose and throat Hospital ,Fudan University

Shanghai, 200031, China

RECRUITING

Related Publications (5)

  • 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.

    PMID: 8337267BACKGROUND

  • 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.

    PMID: 24314181BACKGROUND

  • 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.

    PMID: 25487477BACKGROUND

  • 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.

    PMID: 15923270BACKGROUND

  • 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.

    PMID: 23806943BACKGROUND

MeSH Terms

Conditions

Congenital MicrotiaAgnosia

Condition Hierarchy (Ancestors)

Ear DiseasesOtorhinolaryngologic DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Xiao Hu, Master

    Eye and ENT Hospital of Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Jia, Master

CONTACT

8613641839213jiajie@eentanesthesia.com

Xiao Hu, Master

CONTACT

8613816780317fibrescope@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The attentding physician of Department of Anesthesiology

Study Record Dates

First Submitted

November 25, 2019

First Posted

December 10, 2019

Study Start

February 17, 2020

Primary Completion

September 1, 2020

Study Completion

November 1, 2020

Last Updated

July 28, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)