UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030464 |
|---|---|
| Receipt number | R000034787 |
| Scientific Title | Ispilateral shoulder pain after video-assisted thoracoscopy: a prospective, randomized, double-blind evaluation of the efficacy of infiltrationg the phrenic nerve at the vena azygos level. |
| Date of disclosure of the study information | 2018/01/01 |
| Last modified on | 2021/01/08 10:48:02 |
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Basic information
Public title
Ispilateral shoulder pain after video-assisted thoracoscopy: a prospective, randomized, double-blind evaluation of the efficacy of infiltrationg the phrenic nerve at the vena azygos level.
Acronym
Evaluation of the safety of infiltrationg the phrenic nerve at the vena azygos level.
Scientific Title
Ispilateral shoulder pain after video-assisted thoracoscopy: a prospective, randomized, double-blind evaluation of the efficacy of infiltrationg the phrenic nerve at the vena azygos level.
Scientific Title:Acronym
Evaluation of the safety of infiltrationg the phrenic nerve at the vena azygos level.
Region
| Japan |
Condition
Condition
Patients who are scheduled for elective lobectomy or pneumonectomy for non-small cell lung cancer, aged > 18 years
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To reduce the incidence of ipsilateral shoulder pain after video-assisted thoracoscopy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative pain was assessed using an 11-point numeric rating scale(NRS)
Key secondary outcomes
The excursion value of the shoulder
PONV
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Phrenic nerve block at the vena azygos level
Interventions/Control_2
Infiltrating the phrenic nerve with 0.375% ropivacaine before chest closure
Interventions/Control_3
Infiltrating the phrenic nerve, only once.
Interventions/Control_4
A post-operatively for 2 days observes total of 4 days from the way previous day.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients are scheduled for elective lobectomy or pneumonectomy for non-small cell lung cancer, aged > 18 years
Key exclusion criteria
Patients with contrateral palsy, allergy to ropivacaine, pre-operative history of ipsilateral shoulder pain
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kaori |
| Middle name | |
| Last name | Kuroiwa Kimura |
Organization
Nagano Red Cross Hospital
Division name
Departments of Anesthesia
Zip code
380-8582
Address
5-22-1, Wakasato, Nagano, Japan
TEL
026-226-4131
anesthesi0hanz13@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | Kuroiwa Kimura |
Organization
Nagano Red Cross Hospital
Division name
Departments of Anesthesia
Zip code
380-8582
Address
5-22-1, Wakasato, Nagano, Japan
TEL
026-226-4131
Homepage URL
anesthesi0hanz13@yahoo.co.jp
Sponsor or person
Institute
Nagano Red Cross Hospital
Departments of Anesthesia
Institute
Department
Personal name
Funding Source
Organization
Nagano Red Cross Hospital
Departments of Anesthesia
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagano Red Cross Hospital
Address
5-22-1, Wakasato, Nagano, Japan
Tel
0262264131
anesthesi0hanz13@yahoo.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
長野赤十字病院（長野県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
https://journals.lww.com/anesthesia-analgesia/Fulltext/9900/Phrenic_Nerve_Block_at_the_Azygos_Vein_L
Publication of results
Published
Result
URL related to results and publications
Anesth Analg . 2020 Dec 16. doi: 10.1213/ANE.0000000000005305. Online ahead of print.
Number of participants that the trial has enrolled
85
Results
Eighty-five patients were included, and their data were analyzed. These patients were randomly assigned to either phrenic nerve block group (n = 42) or control group (n = 43). There were no clinically relevant differences in demographic and surgical profiles between the groups. There was no significant difference in the incidence of ipsilateral shoulder pain (the control group 20/43 [46.5%] versus the PNB group 14/42 [33.3%]; P = .215).
Results date posted
| 2021 | Year | 01 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 12 | Month | 16 | Day |
Baseline Characteristics
Inclusion criteria were as follows: patients scheduled for VATS, age >18 years, American Society of Anesthesiologists physical status level <3, and planned use of epidural anesthesia. Exclusion criteria were as follows: patients with contralateral paralysis of the phrenic nerve, allergy to ropivacaine, preoperative history of ISP, chronic pain, contraindications to epidural anesthesia, and/or dementia.
VATS:video-assisted thoracoscopic surgery
ISP:Ipsilateral shoulder pain
Participant flow
The principal investigator and coinvestigators screened patients for eligibility to participate in the study. The investigators explained the rationale of the study to patients who were eligible for study participation. Written informed consent was obtained from all enrolled patients.
Adverse events
In the control group, one patient experienced postoperative pneumonia.
Outcome measures
Postoperative ipsilateral shoulder pain was assessed using a numerical rating scale at rest at 2,4,8,16, and 24 hours. The incidence of ISP was defined as the proportion of patients who reported an NRS score of>=1 at least once within 24 hours after surgery.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 19 | Day |
Last modified on
| 2021 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034787
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