UMIN-CTR Clinical Trial

Public title

An observational cohort study to clarify the prevalence and severity of chronic postsurgical pain after mitral valve repair

Acronym

PAIN-MVP

Scientific Title

An observational cohort study to clarify the prevalence and severity of chronic postsurgical pain after mitral valve repair

Scientific Title:Acronym

PAIN-MVP

Region

Japan

Condition

patients who underwent mitral valve repair in conjunction with other cardiac surgery

Classification by specialty

Surgery in general

Anesthesiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

We hypothesized that the prevalence and severity of CPSP is higher among patients after mitral valve repair via thoracotomy versus sternotomy. To test this hypothesis, we conducted a prospective cohort study

Basic objectives2

Others

Basic objectives -Others

We hypothesized that the prevalence and severity of CPSP is higher among patients after mitral valve repair via thoracotomy versus sternotomy. To test this hypothesis, we conducted a prospective cohort study

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The main outcomes were the severity of CPSP evaluated using NRS and the prevalence of CPSP. CPSP was defined as pain > 0 that developed after a surgical procedure and persisted for at least 3 months after surgery. Between-group differences in severity were compared

Key secondary outcomes

Association between the severity and prevalence of CPSP evaluated using NRS and elapsed time after surgery

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

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

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

patients who underwent mitral valve repair after January 2014.

Key exclusion criteria

none

Target sample size

450

Name of lead principal investigator

1st name	Kimito
Middle name
Last name	Minami

Organization

National Cerebral and Cardiovascular Center

Division name

Department of Surgical Intensive Care

Zip code

564-8565

Address

6-1 Kishibeshinmachi, Suita, Osaka

TEL

06-6170-1070

Email

k.minami@ncvc.go.jp

Name of contact person

1st name	Kimito
Middle name
Last name	Minami

Organization

National Cerebral and Cardiovascular Center

Division name

Department of surgical intensive care

Zip code

564-8565

Address

6-1 Kishibeshinmachi, Suita, Osaka

TEL

06-6170-1070

Homepage URL

Email

k.minami@ncvc.go.jp

Institute

National Cerebral and Cardiovascular Center

Institute

Department

Personal name

Organization

National Cerebral and Cardiovascular Center

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

National Cerebral and Cardiovascular Center

Address

6-1 Kishibeshinmachi, Suita, Osaka

Tel

06-6170-1070

Email

k.minami@ncvc.go.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2020

Year

08

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

https://www.jcvaonline.com/article/S1053-0770(21)00073-2/fulltext

Number of participants that the trial has enrolled

428

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

Main results already published

Date of protocol fixation

2020

Year

07

Month

01

Day

Date of IRB

2020

Year

07

Month

01

Day

Anticipated trial start date

2020

Year

07

Month

01

Day

Last follow-up date

2021

Year

01

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This observational cohort study included surviving patients who underwent mitral valve repair via thoracotomy or sternotomy. A questionnaire about the severity of surgical wound pain evaluated with a numerical rating scale (NRS) was sent to patients who underwent mitral valve repair via sternotomy or thoracotomy. NRS responses for current pain, peak pain in the last 4 weeks, and average pain in the last 4 weeks were evaluated. The main outcomes were the severity of CPSP evaluated using NRS and the prevalence of CPSP. CPSP was defined as pain > 0 that developed after a surgical procedure and persisted for at least 3 months after surgery. Between-group differences in severity were compared using multivariable ordinal logistic regression. Between-group differences in prevalence were compared using multivariable logistic regression.

Registered date

2020

Year

07

Month

04

Day

Last modified on

2021

Year

07

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046820