Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00610

2 Trial Registration Date

2018-05-24

i Registration Status

Prospective

3 Secondary IDs

CREC.2018.195

4 Source(s) of Funding

Department of Anaesthesia & Intensive Care, PWH

5 Primary Sponsor

Department of Anaesthesia & Intensive Care, PWH

6 Secondary Sponsor

NA

Function

Not Applicable

Please specify

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

i Name

Winnie Samy

ii Address

04A49 Department of Anaesthesia & Intensive Care, 4/f Main Clinical Block & Trauma Centre, Prince of Wales Hospital, Shatin, NT

iii Phone

35052735

iv Email

wsamy@cuhk.edu.hk

v Affiliation

Department of Anaesthesia & Intensive Care

vi Country

Hong Kong SAR, China

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

i Name

Pik Yu Chen

ii Address

04A49 Department of Anaesthesia & Intensive Care, 4/f Main Clinical Block & Trauma Centre, Prince of Wales Hospital, Shatin, NT

iii Phone

3505 2735

iv Email

pro910@cuhk.edu.hk

v Affiliation

Department of Anaesthesia & Intensive Care, Prince of Wales Hospital

vi Country

Hong Kong SAR, China

9 Official Scientific Title of the Study

A Retrospective Study to compare Cost and Effectiveness of Intravenous Patient-Controlled Analgesia (IVPCA) Morphine protocol and Preemptive Multimodal Analgesia Oral Etoricoxib and Oxycontin Protocol for Post Total Knee Replacement Patients

10 Public Title

A Retrospective Study to compare Cost and Effectiveness of Intravenous Patient-Controlled Analgesia (IVPCA) Morphine protocol and Preemptive Multimodal Analgesia Oral Etoricoxib and Oxycontin Protocol for Post Total Knee Replacement Patients

i Public Title in Chinese 研究名稱

not applicable, no active patient involvement, No Chinese title

11 Short Title (Optional)

12 Countries of Recruitment

Hong Kong SAR, China

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2018-05-04

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2018.195

14 Medical Condition Being Studied

Total Knee Replacement

15 Intervention

i Types of intervention

Other

Please specify

Pain management treatment methods/ regimens (restrospective study)

ii Description/ name of Intervention/article

Retrospectively compare two pain management regimens (Preemptive Multimodal Analgesia [PMA] regmien and Intravenous Patient-Controlled Analgesia [IVPCA]) for patients undergone total knee replacement at different period in terms of cost effectiveness & benefits. Data including demographic data, comorbidity characteristics, pain score, rehabilitation progress and length of hospital stay will be collected from Clinical Management System, patient's hospital record and acute pain database. In addition, the total cost of each pain management regimen will be calculated and compared.
Since it is retrospective study, so informed consent has been exempted & approved by EC. There is no Chinese title for this study.

iii Dosage form of the intervention

not a pharmaceutical study; compare two treatment methods only

iv Dosage of the intervention

not a pharmaceutical study

v Duration of the intervention

5 days after surgery

vi Frequency of the intervention

not applicable; now retrospectively collect data once only

16 Comparative Treatments

i Description/ name of comparative treatments

The group of patients who had Preemptive multimodal analgesia (PMA) from September 2017 to February 2018 are considered as intervention group. The group who had Intravenous patient-controlled analgesia (IVPCA) from September 2016 to February 2017 are considered as conventional group. Both groups will be compared for the demographic data, comorbidity characteristics, pain score, rehabilitation progress, length of hosptial stay, the total expense, and overall patient satisfaction to treatment.

ii Dosage form of the comparative treatments

Not a pharmaceutical study

iii Dosage of the comparative treatments

Not a pharmaceutical study

iv Duration of the comparative treatments

5 days after surgery

v Frequency of the comparative treatments

not applicable; now retrospectively collect data once only

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Only patients with similar demographics including age, body weight ≥ 44kg,operation, anaesthesia type, medical condition, & postoperative treatment data of both groups who had attended pain management class or pre-operative anesthesia assessment clinic

ii Exclusion Criteria

Patients who had not attended pain management class or pre-operative anesthesia assessment clinic, non-schedule operation, underwent bilateral TKR, severe psychological illness, active or history of drug abuse, incompliance to either treatment group or contra-indicated to the analgesics used.

iii Age Minimum

18

iv Age Maximum

90

v Gender

Both Male and Female

18 Study Type

Observational

19 Study Design

i Randomization

Not Applicable

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Not Applicable

If Single-blind, who will be masked?

iv Group Assignment

Not Applicable

v Study Phase

4

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2018-06-04

21 Target Sample Size

102

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

pain score

ii The metric or method of measurement used

numeric rating scale (NRS 0-100, 0=no pain; 10=the worst imaginable pain)

iii The timepoint(s) of primary interest

post surgery day 1 and day 4 that can be retrieved from Clinical Management System, patients' hospital records and acute pain database

24 Secondary Outcome

i The Name of the outcome

cost of conventional and intervention treatments, the functional status, overall patient satisfaction to treatment, length of hospital stay, side effects from analgesics

ii The metric or method of measurement used

functional status are measured by days to mobilize such as sitting out, walking and standing

iii The timepoint(s) of primary interest

Except the functional status that obtained from day 1 & 4, the others were obtained on day 4. These data can be retrieved from CMS, patients' hospital records and acute pain database

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2019-06-18

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

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Trial History Detail on 2018-06-13