MicrotiaPhase 4NCT04192708
Study of Analgesic Efficacy of Nerve Blocks on Otoplastic Surgery
A Phase 4 study testing intercostal nerve block under direct vision, intercostal nerve block under ultrasound guidance and paravertebral block under ultrasound guidance in people with Microtia and Microtia, Congenital, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Microtia, Microtia, Congenital
- What is being tested?
- intercostal nerve block under direct vision, intercostal nerve block under ultrasound guidance and paravertebral block under ultrasound guidance
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 17 Feb 2020to Nov 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical diagnosis of microtia
- Scheduled for rib cartilage harvest from three ribs for auricular reconstruction.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Eye,Ear,Nose and throat Hospital ,Fudan University
Shanghai, 200031
Xiao Hu, Master, 8613816780317, fibrescope@hotmail.com
About this study
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.
Read the 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 .
- Conditions
- Microtia, Microtia, Congenital
- Being tested
- intercostal nerve block under direct vision, intercostal nerve block under ultrasound guidance, paravertebral block under ultrasound guidance
- Keywords
- intercostal nerve blocks, ultrasound guidance, thoracic paravertebral block, pain management
- Medical subject headings
- Congenital Microtia, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intercostal nerve block under direct visionProcedure or surgery
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.
intercostal nerve block under ultrasound guidanceProcedure or surgery
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.
paravertebral block under ultrasound guidanceProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| DV-ICNB group | Experimental | intercostal nerve block under direct vision Receives: Procedure: intercostal nerve block under direct vision |
| UG-ICNB group | Experimental | intercostal nerve block under ultrasound guidance Receives: Procedure: intercostal nerve block under ultrasound guidance |
| PV group | Experimental | thoracic paravertebral block under ultrasound guidance Receives: Procedure: paravertebral block under ultrasound guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest pain at rest
Assessed by Visual Analogue Scale（VAS）,(0,no pain；10，the worst pain)
Measured: 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)
Measured: Time2: 3 hours after surgery
Chest pain at rest
Assessed by Visual Analogue Scale（VAS）,(0,no pain；10，the worst pain)
Measured: Time3: 6 hours after surgery
Chest pain at rest
Assessed by Visual Analogue Scale（VAS）,(0,no pain；10，the worst pain)
Measured: Time4: 24 hours after surgery
Chest pain at rest
Assessed by Visual Analogue Scale（VAS）,(0,no pain；10，the worst pain)
Measured: Time5: 48 hours after surgery
Chest pain during deep breath
Assessed by Visual Analogue Scale（VAS）,(0,no pain；10，the worst pain)
Measured: 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)
Measured: Time2: 3 hours after surgery
Chest pain during deep breath
Assessed by Visual Analogue Scale（VAS）,(0,no pain；10，the worst pain)
Measured: Time3: 6 hours after surgery
Chest pain during deep breath
Assessed by Visual Analogue Scale（VAS）,(0,no pain；10，the worst pain)
Measured: Time4: 24 hours after surgery
Chest pain during deep breath
Assessed by Visual Analogue Scale（VAS）,(0,no pain；10，the worst pain)
Measured: Time5: 48 hours after surgery
Ear pain at rest
Assessed by Visual Analogue Scale（VAS）,(0,no pain；10，the worst pain)
Measured: 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)
Measured: Time2: 3 hours after surgery
Ear pain at rest
Assessed by Visual Analogue Scale（VAS）,(0,no pain；10，the worst pain)
Measured: Time3: 6 hours after surgery
Ear pain at rest
Assessed by Visual Analogue Scale（VAS）,(0,no pain；10，the worst pain)
Measured: Time4: 24 hours after surgery
Ear pain at rest
Assessed by Visual Analogue Scale（VAS）,(0,no pain；10，the worst pain)
Measured: Time5: 48 hours after surgery
Ear pain during deep breath
Assessed by Visual Analogue Scale（VAS）,(0,no pain；10，the worst pain)
Measured: 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)
Measured: Time2: 3 hours after surgery
Ear pain during deep breath
Assessed by Visual Analogue Scale（VAS）,(0,no pain；10，the worst pain)
Measured: Time3: 6 hours after surgery
Ear pain during deep breath
Assessed by Visual Analogue Scale（VAS）,(0,no pain；10，the worst pain)
Measured: Time4: 24 hours after surgery
Ear pain during deep breath
Assessed by Visual Analogue Scale（VAS）,(0,no pain；10，the worst pain)
Measured: Time5: 48 hours after surgery
PCIA consumption
Assessed by consumption of patient-controlled intravenous analgesia
Measured: Time1:3 hours after surgery
PCIA consumption
Assessed by consumption of patient-controlled intravenous analgesia
Measured: Time2:6 hours after surgery
PCIA consumption
Assessed by consumption of patient-controlled intravenous analgesia
Measured: Time3:24 hours after surgery
PCIA consumption
Assessed by consumption of patient-controlled intravenous analgesia
Measured: Time4:48 hours after surgery
Nausea severity
Assessed by Verbal Rating Scale（VRS）,(0,no pain；10，the worst pain)
Measured: Time1:3 hours after surgery
Nausea severity
Assessed by Verbal Rating Scale（VRS）,(0,no pain；10，the worst pain)
Measured: Time2:6 hours after surgery
Nausea severity
Assessed by Verbal Rating Scale（VRS）,(0,no pain；10，the worst pain)
Measured: Time3:24 hours after surgery
Nausea severity
Assessed by Verbal Rating Scale（VRS）,(0,no pain；10，the worst pain)
Measured: Time4:48 hours after surgery
Number of vomiting
Assessed by vomiting times after surgery
Measured: Time1:3 hours after surgery
Number of vomiting
Assessed by vomiting times after surgery
Measured: Time2:6 hours after surgery
Number of vomiting
Assessed by vomiting times after surgery
Measured: Time3:24 hours after surgery
Number of vomiting
Assessed by vomiting times after surgery
Measured: Time4:48 hours after surgery
Intraoperative fentanyl requirement
Assessed by total requirement of fentanyl( µg/kg) during the surgery
Measured: Time1:0 minute after surgery
Secondary outcomes (3)
The first time of urination
Assessed by the duration(hour) between end of surgery and the first time of urination
Measured: Time1:0 minute after 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
Measured: Time1:0 minute after all three rib cartilage are harvested
Fentanyl requirement in PACU
Assessed by total additional requirement of fentanyl for keeping VAS scores less than '5'
Measured: Time1:0 minute after departure from the PACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start17 Feb 2020
- Primary completionSep 2020 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for MicrotiaStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao Hu, Eye & ENT Hospital of Fudan University
- Investigators
- Xiao Hu, Master, Principal investigator, Eye & ENT Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04192708
- Sponsor's protocol ID
- chevalier
- Status last verified
- Jul 2020
- First submitted
- 25 Nov 2019
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 8337267Lukosiene 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.
PubMed 24314181Lukosiene 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.
PubMed 25487477Willschke 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.
PubMed 15923270Vemula 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.
PubMed 23806943
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Analgesic Efficacy of Different Kinds of Nerve Blocks on Otoplastic Surgery
- ClinicalTrials.gov ID
- NCT04192708
- Acronym / sponsor ID
- chevalier
- Conditions
- Microtia, Microtia, Congenital
- Keywords
- intercostal nerve blocks, ultrasound guidance, thoracic paravertebral block, pain management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 10 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DV-ICNB group | Experimental | Procedure: intercostal nerve block under direct visionintercostal nerve block under direct vision |
| UG-ICNB group | Experimental | Procedure: intercostal nerve block under ultrasound guidanceintercostal nerve block under ultrasound guidance |
| PV group | Experimental | Procedure: paravertebral block under ultrasound guidancethoracic paravertebral block under ultrasound guidance |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Clinical diagnosis of microtia
- Scheduled for rib cartilage harvest from three ribs for auricular reconstruction.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intercostal nerve block under direct visionWhen 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 or surgery | DV-ICNB group |
| intercostal nerve block under ultrasound guidanceAfter 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 or surgery | UG-ICNB group |
| paravertebral block under ultrasound guidanceParavertebral 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 | Procedure or surgery | PV group |
Primary outcome
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
3 secondary outcomes
The first time of urination
Time frame: Time1:0 minute after the first time of urination
Blood loss during harvesting rib cartilage
Time frame: Time1:0 minute after all three rib cartilage are harvested
Fentanyl requirement in PACU
Time frame: Time1:0 minute after departure from the PACU
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Background: PubMed 8337267Nagata 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.
- Background: PubMed 24314181Lukosiene 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.
- Background: PubMed 25487477Lukosiene 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.
- Background: PubMed 15923270Willschke 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.
- Background: PubMed 23806943Vemula 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiao Hu, Master principal investigator
Eye & ENT Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing intercostal nerve block under direct vision, intercostal nerve block under ultrasound guidance and paravertebral block under ultrasound guidance in people with Microtia and Microtia, Congenital, run by Eye & ENT Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Jia, Master (8613641839213, jiajie@eentanesthesia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chest pain at rest (time frame: Time1:0 minute after the first pain score could be obtained from the patient). The study lists 33 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04192708, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2020.