UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022970
Receipt number 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 15:54:17

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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 or person

Institute

National Hospital Organization, Kanagawa Hospital

Institute

Department

Personal name



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

Value
https://center6.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