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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022970
Receipt No. R000026426
Scientific Title Effect of pregabalin combined with NSAIDs and thoracic epidural analgesia on pain after thoracotomy in lung cancer
Date of disclosure of the study information 2016/07/01
Last modified on 2016/07/01

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Basic information
Public title Effect of pregabalin combined with NSAIDs and thoracic epidural analgesia on pain after thoracotomy in lung cancer
Acronym Effect of pregabalin after thoracotomy
Scientific Title Effect of pregabalin combined with NSAIDs and thoracic epidural analgesia on pain after thoracotomy in lung cancer
Scientific Title:Acronym Effect of pregabalin after thoracotomy
Region
Japan

Condition
Condition lung cancer
Classification by specialty
Surgery in general Chest surgery Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this prospective and randomized study was to assess the analgesic efficacy, adverse effects and clinical value of pregabalin with NSAIDs and thoracic epidural analgesia (TEA), comparing to the pain management without pregabalin in post-operative thoracotomy-relating pain.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Pain score (NRS) after removing the thoracic epidural analgesia (TEA)
Key secondary outcomes Daily pain score
Times of oatient Controlled analgesia (PCA) injection of thoracic epidural analgesia
Pain scale in the morning, evening and sleeping
Occurrence rate and severity of adverse effects

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 An epidural catheter was inserted at the T4-T5 interspace in the operating room just before starting the general anesthesia. An epidural test dose of 3mL lidocaine 10mg/mL, 5 mL ropivacaine 7.5 mg/mL was administered epidurally before the induction of general anaesthesia, followed by a continuous infusion of 5 mL/hr during surgery. An additional bolus of 5 mL ropivacaine 7.5 mg/mL was injected during chest closure. General anaesthesia was induced and maintained with an i.v. infusion of 0.2 microgram/kg/min remifentanil and a target-controlled infusion of propofol. Postoperative analgesia was provided to all patients with a patient-controlled epidural analgesia (PCEA) pump using a combination of ropivacaine 2 mg/mL and fentanyl 10 microgram/mL by continuous infusion at 4 mL/hr, bolus 3 mL, and lockout interval 20min. PCEA was maintained until the moning of the third post-operative day. Patients in the both groups were given 60 mg three times a day oral loxoprofen (Loxonin, Daiichi Sankyo Inc., Tokyo, Japan) from the lung on the first post-operative day. In the cases of inadequate analgesia (pain score at rest >5 on the numerical rating scale: NRS), 60 mg oral loxoprofen or 25mg suppository diclofenac was administered as rescue medication.
Interventions/Control_2 An epidural catheter was inserted at the T4-T5 interspace in the operating room just before starting the general anesthesia. An epidural test dose of 3mL lidocaine 10mg/mL, 5 mL ropivacaine 7.5 mg/mL was administered epidurally before the induction of general anaesthesia, followed by a continuous infusion of 5 mL/hr during surgery. An additional bolus of 5 mL ropivacaine 7.5 mg/mL was injected during chest closure. General anaesthesia was induced and maintained with an i.v. infusion of 0.2 microgram/kg/min remifentanil and a target-controlled infusion of propofol. Postoperative analgesia was provided to all patients with a patient-controlled epidural analgesia (PCEA) pump using a combination of ropivacaine 2 mg/mL and fentanyl 10 microgram/mL by continuous infusion at 4 mL/hr, bolus 3 mL, and lockout interval 20min. PCEA was maintained until the moning of the third post-operative day. Patients in the both groups were given 60 mg three times a day oral loxoprofen (Loxonin, Daiichi Sankyo Inc., Tokyo, Japan) from the lung on the first post-operative day. In the cases of inadequate analgesia (pain score at rest >5 on the numerical rating scale: NRS), 60 mg oral loxoprofen or 25mg suppository diclofenac was administered as rescue medication.
The patients in pregabalin, NSAIDs and TEA group were given 75 mg pregabalin at the noon and the evening on the first post-operative day, and 150 mg pregabalin three times a day after meals since the second post-operative day.The patients in pregabalin, NSAIDs and TEA group were given 75 mg pregabalin at the noon and the evening on the first post-operative day, and 150 mg pregabalin three times a day after meals since the second post-operative day.
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 lung cancer patients who can undergo lobectomy and pneumonectomy, and who epidural catheter is inserted at the T4-T5 interspace in the operating room.
patients who have signed the consent form to participate in this study.
patients over 20 years old when participate in this study.
Key exclusion criteria patients with serious complications (such as asthma, renal disease, gastric ulcer), which are contraindication of NSAIDs.
patients over P 3 (ECOG)
patients considered unsuitable for the study by a primary physician
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasoo Sugiura
Organization National Hospital Organization, Kanagawa National Hospital
Division name General Thoracic Surgery
Zip code
Address 666-1 Ochiai, Hadano City, Kanagawa Japan
TEL 0463-81-1771
Email yasoos@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yasoo Sugiura
Organization National Hospital Organization, Kanagawa National Hospital
Division name General Thoracic Surgery
Zip code
Address 666-1 Ochiai, Hadano City, Kanagawa Japan
TEL 0463-81-1771
Homepage URL
Email yasoos@hotmail.com

Sponsor
Institute National Hospital Organization, Kanagawa Hospital
Institute
Department

Funding Source
Organization Not applicable
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
Address
Tel
Email

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
2016 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 09 Month 01 Day
Last follow-up date
2014 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 07 Month 01 Day
Last modified on
2016 Year 07 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026426

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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