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Study of Analgesic Efficacy of Nerve Blocks on Otoplastic Surgery

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ClinicalTrials.gov Identifier: NCT04192708
Recruitment Status : Recruiting
First Posted : December 10, 2019
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
Xiao Hu, Eye & ENT Hospital of Fudan University

Tracking Information
First Submitted Date  ICMJE November 25, 2019
First Posted Date  ICMJE December 10, 2019
Last Update Posted Date July 28, 2020
Actual Study Start Date  ICMJE February 17, 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2019)
  • Chest pain at rest [ Time Frame: Time1:0 minute after the first pain score could be obtained from the patient ]
    Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
  • Chest pain at rest [ Time Frame: Time2: 3 hours after surgery ]
    Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
  • Chest pain at rest [ Time Frame: Time3: 6 hours after surgery ]
    Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
  • Chest pain at rest [ Time Frame: Time4: 24 hours after surgery ]
    Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
  • Chest pain at rest [ Time Frame: Time5: 48 hours after surgery ]
    Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
  • Chest pain during deep breath [ Time Frame: Time1:0 minute after the first pain score could be obtained from the patient ]
    Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
  • Chest pain during deep breath [ Time Frame: Time2: 3 hours after surgery ]
    Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
  • Chest pain during deep breath [ Time Frame: Time3: 6 hours after surgery ]
    Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
  • Chest pain during deep breath [ Time Frame: Time4: 24 hours after surgery ]
    Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
  • Chest pain during deep breath [ Time Frame: Time5: 48 hours after surgery ]
    Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
  • Ear pain at rest [ Time Frame: Time1:0 minute after the first pain score could be obtained from the patient ]
    Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
  • Ear pain at rest [ Time Frame: Time2: 3 hours after surgery ]
    Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
  • Ear pain at rest [ Time Frame: Time3: 6 hours after surgery ]
    Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
  • Ear pain at rest [ Time Frame: Time4: 24 hours after surgery ]
    Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
  • Ear pain at rest [ Time Frame: Time5: 48 hours after surgery ]
    Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
  • Ear pain during deep breath [ Time Frame: Time1:0 minute after the first pain score could be obtained from the patient ]
    Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
  • Ear pain during deep breath [ Time Frame: Time2: 3 hours after surgery ]
    Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
  • Ear pain during deep breath [ Time Frame: Time3: 6 hours after surgery ]
    Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
  • Ear pain during deep breath [ Time Frame: Time4: 24 hours after surgery ]
    Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
  • Ear pain during deep breath [ Time Frame: Time5: 48 hours after surgery ]
    Assessed by Visual Analogue Scale(VAS),(0,no pain;10,the worst pain)
  • PCIA consumption [ Time Frame: Time1:3 hours after surgery ]
    Assessed by consumption of patient-controlled intravenous analgesia
  • PCIA consumption [ Time Frame: Time2:6 hours after surgery ]
    Assessed by consumption of patient-controlled intravenous analgesia
  • PCIA consumption [ Time Frame: Time3:24 hours after surgery ]
    Assessed by consumption of patient-controlled intravenous analgesia
  • PCIA consumption [ Time Frame: Time4:48 hours after surgery ]
    Assessed by consumption of patient-controlled intravenous analgesia
  • Nausea severity [ Time Frame: Time1:3 hours after surgery ]
    Assessed by Verbal Rating Scale(VRS),(0,no pain;10,the worst pain)
  • Nausea severity [ Time Frame: Time2:6 hours after surgery ]
    Assessed by Verbal Rating Scale(VRS),(0,no pain;10,the worst pain)
  • Nausea severity [ Time Frame: Time3:24 hours after surgery ]
    Assessed by Verbal Rating Scale(VRS),(0,no pain;10,the worst pain)
  • Nausea severity [ Time Frame: Time4:48 hours after surgery ]
    Assessed by Verbal Rating Scale(VRS),(0,no pain;10,the worst pain)
  • Number of vomiting [ Time Frame: Time1:3 hours after surgery ]
    Assessed by vomiting times after surgery
  • Number of vomiting [ Time Frame: Time2:6 hours after surgery ]
    Assessed by vomiting times after surgery
  • Number of vomiting [ Time Frame: Time3:24 hours after surgery ]
    Assessed by vomiting times after surgery
  • Number of vomiting [ Time Frame: Time4:48 hours after surgery ]
    Assessed by vomiting times after surgery
  • Intraoperative fentanyl requirement [ Time Frame: Time1:0 minute after surgery ]
    Assessed by total requirement of fentanyl( µg/kg) during the surgery
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2019)
  • The first time of urination [ Time Frame: 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 [ Time Frame: Time1:0 minute after all three rib cartilage are harvested ]
    Assessed by the blood loss(ml) ) when surgeons are harvesting rib cartilage for auricular reconstruction
  • Fentanyl requirement in PACU [ Time Frame: Time1:0 minute after departure from the PACU ]
    Assessed by total additional requirement of fentanyl for keeping VAS scores less than '5'
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Analgesic Efficacy of Nerve Blocks on Otoplastic Surgery
Official Title  ICMJE Study of Analgesic Efficacy of Different Kinds of Nerve Blocks on Otoplastic Surgery
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 .

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Microtia
  • Microtia, Congenital
Intervention  ICMJE
  • Procedure: intercostal nerve block under direct vision
    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.
  • Procedure: intercostal nerve block under ultrasound guidance
    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.
  • Procedure: paravertebral block under ultrasound guidance
    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
Study Arms  ICMJE
  • Experimental: DV-ICNB group
    intercostal nerve block under direct vision
    Intervention: Procedure: intercostal nerve block under direct vision
  • Experimental: UG-ICNB group
    intercostal nerve block under ultrasound guidance
    Intervention: Procedure: intercostal nerve block under ultrasound guidance
  • Experimental: PV group
    thoracic paravertebral block under ultrasound guidance
    Intervention: Procedure: paravertebral block under ultrasound guidance
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 7, 2019)
144
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jie Jia, Master 8613641839213 jiajie@eentanesthesia.com
Contact: Xiao Hu, Master 8613816780317 fibrescope@hotmail.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04192708
Other Study ID Numbers  ICMJE chevalier
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Xiao Hu, Eye & ENT Hospital of Fudan University
Study Sponsor  ICMJE Eye & ENT Hospital of Fudan University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Xiao Hu, Master Eye and ENT Hospital of Fudan University
PRS Account Eye & ENT Hospital of Fudan University
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP