Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00276

2 Trial Registration Date

2010-11-11

i Registration Status

Prospective

3 Secondary IDs

2010/11/11

4 Source(s) of Funding

Departmental and Australian and New Zealand College of Anaesthetists

5 Primary Sponsor

General Research Fund, Research Grant Council

6 Secondary Sponsor

NA

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Matthew Chan

ii Address

c/-Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong, Prince of Wales Hospital

iii Phone

2632 2736

iv Email

mtvchan@cuhk.edu.hk

v Affiliation

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Matthew Chan

ii Address

c/-Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong, Prince of Wales Hospital

iii Phone

2632 2736

iv Email

mtvchan@cuhk.edu.hk

v Affiliation

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

Persistent Pain After Surgery: Incidence, Impact and Risk Factors

10 Public Title

Persistent pain after surgery

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

NA

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2010-03-18

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Pain after surgery

15 Intervention

i Types of intervention

Other

Please specify

NA

ii Description/ name of Intervention/article

NA

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

NA

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

NA

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Adult male and female patients, aged ≥18 years, undergoing a surgical procedure that includes a skin incision

ii Exclusion Criteria

Patients will be excluded if they require a pure endoscopic or radiologic procedure. Patients previously enrolled in the study and patients who are not expected to be available for, or to cooperate with, interviews will also be excluded

iii Age Minimum

≥ 18 years

iv Age Maximum

NA

v Gender

Both Male and Female

18 Study Type

Observational

19 Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Uncontrolled

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2010-12-01

21 Target Sample Size

5,000

22 Recruitment Status

Recruiting

23 Primary Outcome

Presence of severe pain that has arisen and persisted for 12 months after the indexed surgery that is not due to disease recurrence or pre-existing pain syndrome

24 Secondary Outcome

1. Persistent pain lasting for 12 months after surgery.
2. The interference of chronic post-surgical pain with daily activities.
3. The impact of chronic post-surgical pain on general health status.
4. The proportion of patients seeking pain related treatment.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-01-13

27 Primary Registry and Trial Identifying Number

ChiCTR-ONC-10001099

28 Date of Registration in Primary Registry

2010-12-01

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

NA

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Trial History Detail on 2013-12-12