UMIN-CTR Clinical Trial

Basic information
Public title	A randomized prospective comparison of programmed intermittent bolus with continuous infusion for ultrasound-guided erector spinae plane block in video-assisted thoracic surgery
Acronym	A randomized prospective study of two different infusion protocol of ultrasound-guided erector spinae plane block
Scientific Title	A randomized prospective comparison of programmed intermittent bolus with continuous infusion for ultrasound-guided erector spinae plane block in video-assisted thoracic surgery
Scientific Title:Acronym	A randomized prospective study of two different infusion protocol of ultrasound-guided erector spinae plane block
Region	Japan

Condition
Condition	Lung tumor
Classification by specialty	Chest surgery Anesthesiology Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Verifying the difference of anesthetized dermatomes between two different drug infusion protocol for ultrasound-guided erecor spinae plane block in video-assisted thoracic surgery
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The number of anesthetized dermatomes
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Device,equipment
Interventions/Control_1	Using programmed intermittent bolus infusion postoperatively
Interventions/Control_2	Using continuous infusion postoperatively
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Provided written informed consent 2.American Society of Anesthesiologists physical status 1-3 3.Scheduled to undergo complete video-assisted thoracoscopic surgery for lung cancer.
Key exclusion criteria	allergy to local anesthetics BMI>30 age< 20 or >80 Liver function disorder Renal function disorder (eGFR<50) History of past ipsilateral thoracotomy Normally using opioid analgesics Treated mental or neurological disorders Allergy to acetaminophen, NSAIDs, and fentanyl. Difficulty in adequate verbal communication Thoracotomy with rib cutting or pleurectomy
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Taro Middle name Last name Fujitani
Organization	Ehime Prefectural Central Hospital
Division name	Department of Anesthesiology and Critical Care
Zip code	790-0024
Address	83 Kasuga-machi Matsuyama Ehime Japan 790-0024
TEL	089-947-1111
Email	suko1231@yahoo.co.jp

Public contact
Name of contact person	1st name Yasuko Middle name Last name Taketa
Organization	Ehime Prefectural Cenral Hospital
Division name	Department of Anesthesia and Critical Care
Zip code	790-0024
Address	83 Kasuga-machi Matsuyama Ehime Japan 790-0024
TEL	089-947-1111
Homepage URL
Email	suko1231@yahoo.co.jp

Sponsor
Institute	Ehime Prefectural Central Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional review board of Ehime Prefectural Central Hospital
Address	83 Kasuga-machi Matsuyama Ehime Japan 790-0024
Tel	089-947-1111
Email	suko1231@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

Other administrative information
Date of disclosure of the study information	2019 Year 05 Month 01 Day

Related information
URL releasing protocol	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041671
Publication of results	Unpublished

Result
URL related to results and publications	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041671
Number of participants that the trial has enrolled	50
Results	The number of dermatomes desensitized in the midclavicular line was significantly higher in group P than in group C (p<0.001). The amount of rescue morphine consumed in the early postoperative period (0-24h) was significantly lower in group P (p=0.035). No significant difference in postoperative numerical rating scale score was found between the groups.
Results date posted	2021 Year 05 Month 08 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	we enrolled those with American Society of Anesthesiologists physical status 1-3 who were scheduled to undergo video-assisted lobectomy for lung cancer between June 2019 and March 2020. Patients who met the following criteria were excluded: inability to provide consent, aged <20 or >80 years, body mass index >30 kg/m2, coagulopathy, history of thoracotomy or breast surgery, use of opioid analgesics, mental or neurological disorders, allergy to perioperative medications, bronchial asthma, impaired renal function with estimated glomerular filtration rate <50 mL/min, and scheduled thoracotomy with rib cutting or pleurectomy.
Participant flow	After obtaining written informed consent from the patients, we enrolled the participants.
Adverse events	No adverse events, such as allergy to local anesthetics, pneumothorax, hematoma, or nerve injury during the study period, were observed.
Outcome measures	The primary outcome was the number of desensitized dermatomes in the midclavicular line. The secondary outcomes were the number of desensitized dermatomes in the paraspinal, anterior axillary, and parasternal regions; numerical rating scale (NRS) score at rest and during movement; total rescue morphine consumption at 0-24 and 24-48 h postoperatively; and postoperative nausea and vomiting (PONV) frequency.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2019 Year 04 Month 24 Day
Date of IRB	2019 Year 06 Month 13 Day
Anticipated trial start date	2019 Year 06 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

At the time of protocol registration, the primary endpoint of this study was "the number of anesthetized dermatomes at 20 hours after the initial administration," but because this time point would be affected by the bolus timing in the PIB group, the measurement time was changed to 21 hours after the initial administration before starting the study. In addition, the description of the endpoints was changed because it was necessary to include data 5 hours after the first dose for statistical analysis.

Management information
Registered date	2019 Year 04 Month 22 Day
Last modified on	2022 Year 04 Month 24 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041671