UMIN-CTR Clinical Trial

Public title

Randomized study comparing epidural anesthesia and pregabalin for perioperative pain control after thoracotomy

Acronym

Randomized study comparing epidural anesthesia and pregabalin for perioperative pain control after thoracotomy

Scientific Title

Randomized study comparing epidural anesthesia and pregabalin for perioperative pain control after thoracotomy

Scientific Title:Acronym

Randomized study comparing epidural anesthesia and pregabalin for perioperative pain control after thoracotomy

Region

Japan

Condition

patients undergoing thoracotomy requiring manipulation intercostals and ribs

Classification by specialty

Surgery in general	Chest surgery	Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To investigate a novel method for perioperative pain control by conducting a comparative study to assess the efficacy and safety of epidural anesthesia and pregabalin after thoracotomy

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Pain score (NRS) on the first postoperative day (1 POD NRS)

Key secondary outcomes

Pain score (NRS) on the third and fifth postoperative day (3, 5 POD NRS)
Frequency of analgesic drug use for pain control
Sleep disorder score on the first, third, and fifth postoperative day
Occurrence rate and severity of adverse effects
Time periods of anesthesia in preparation for and during surgery

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Epidural anesthesia group
-Initial medication on the day of surgery:
Oral administration of 400mg of celecoxib
-Medication 6 hours after administering initial dose:
Oral administration of 200mg of celecoxib
-During surgery:
Pain control by epidural anesthesia with continuing administration of 0.2% ropivacaine hydrochloride and fentanyl for 48 hours after surgery
-Medication one day after surgery:
Oral administration of 200mg celecoxib 2T 2x (morning and evening)

Interventions/Control_2

Pregabalin group
-Initial medication on the day of surgery:
Oral administration of 400mg of celecoxib and 75mg of pregabalin
-Medication 6 hours after administering initial dose:
Oral administration of 200mg of celecoxib and 75mg of pregabalin
-Medication one day after surgery:
Oral administration of 200mg celecoxib 2T 2x (morning and evening) and 75mg of pregabalin 2T 2x (morning, evening)

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

patients with PS 0 or 1 (ECOG)
patients undergoing thoracotomy requiring manipulation intercostals and ribs
patients with normal kidney function with creatinine clearance (Ccr, hereafter)
>30ml/min
patients who have signed the consent form to participate in this study

Key exclusion criteria

patients who are taking antidepressants, anti-seizure drugs, and/or opioids prior to surgery
patients with serious complications (such as uncontrollable heart, lung, liver or kidney
disease, and diabetes)
patients with a history of angioedema
female patients who are pregnant, nursing, or might be pregnant (voluntary)
patients who are problematic in receiving epidural anesthesia (such as patients with spinal deformity and patients undergoing treatment with anticoagulants)
patients considered unsuitable for the study by a primary physician

Target sample size

96

Name of lead principal investigator

1st name
Middle name
Last name	Noriyuki Matsutani

Organization

Teikyo University School of Medicine

Division name

Surgery

Zip code

Address

2-11-1 Kaga, Itabashi-ku Tokyo Japan

TEL

+81-3-3964-1231

Email

matsutani1970@yahoo.co.jp

Name of contact person

1st name
Middle name
Last name	Noriyuki Matsutani

Organization

Teikyo University School of Medicine

Division name

Surgery

Zip code

Address

2-11-1 Kaga, Itabashi-ku Tokyo, Japan

TEL

+81-3-3964-1231

Homepage URL

http://teikyohaigeka.com/

Email

matsutan@med.teikyo-u.ac.jp

Institute

Teikyo University School of Medicine

Institute

Department

Personal name

Organization

Pfizer

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

帝京大学医学部外科

Date of disclosure of the study information

2017

Year

03

Month

01

Day

URL releasing protocol

Publication of results

Published

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

Recruitment status

Completed

Date of protocol fixation

2013

Year

10

Month

18

Day

Date of IRB

Anticipated trial start date

2014

Year

01

Month

06

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

02

Month

28

Day

Last modified on

2018

Year

03

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014902