UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A comparative study of analgesic effects between continuous epidural infusion (CEI) and programmed intermittent epidural bolus (PIEB) after video-assisted thoracoscopic surgery for lung tumors.
Title of the study (Brief title)	Comparison of CEI and PIEB after video-assisted thoracoscopic surgery.
Region	Japan

Condition
Condition	Lung tumors
Classification by specialty	Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of postoperative epidural analgesia between continuous epidural infusion and programmed intermittent epidural bolus delivered by the Computerized Ambulatory Drug Delivery pump (CADD pump).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Numerical Rating Scale of postoperative pain at rest and with coughing shortly, 1, 2, and 4 hours after admission to the ICU,
Key secondary outcomes	1) Extent of cold and pain sensory blockade on the first postoperative day. 2) Patient satisfaction 3) Occurrence of complications such as hypotension, bradycardia, hypopnea, nausea, and vomiting. 4) Frequency of patient controlled analgesia (PCA). 5) Total amount of rescue analgesic medication.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Continuous epidural infusion with ropivacaine 0.15% plus fentanyl 2.5 microgram/ml at a dose of 4 ml/h to patients till next morning after video-assisted thoracoscopic surgery for lung tumors.
Interventions/Control_2	Programmed intermittent epidural bolus delivered by the CADD pump with ropivacaine 0.15% plus fentanyl 2.5 microgram/ml at a dose of 3 ml every 45 minutes for a period of one minute to patients till next morning after video-assisted thoracoscopic surgery for lung tumors.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients undergoing video-assisted thoracoscopic surgery under general and epidural anesthesia, who are scheduled to be admitted to the ICU after surgery.
Key exclusion criteria	1) An American Society of Anesthesiologists Physical status of more than 3. 2) A patient who has a history of allergies or intolerance to local anesthetics or fentanyl. 3) A patient undergoing surgery without epidural anesthesia. 4) A patient undergoing another surgical procedure in combination with video-assisted thoracoscopic surgery. 5) A patient of less than height 150cm. 6) A patient who does not agree to participate this study.
Target sample size	90

Research contact person
Name of lead principal investigator	Arisa Hotta
Organization	Sumitomo Hospital
Division name	Department of Anesthesiology
Address	5-3-20 Nakanoshima, Kita-ku, Osaka city, Osaka
TEL	81-6-6443-1261
Email	hotta-arisa@sumitomo-hp.or.jp

Public contact
Name of contact person	Arisa Hotta
Organization	Sumitomo Hospital
Division name	Department of Anesthesiology
Address	5-3-20 Nakanoshima, Kita-ku, Osaka city, Osaka
TEL	81-6-6443-1261
Homepage URL
Email	hotta-arisa@sumitomo-hp.or.jp

Sponsor
Institute	Sumitomo Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2015 Year 12 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 21 Day
Anticipated trial start date	2015 Year 12 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 12 Month 21 Day
Last modified on	2017 Year 06 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023435