Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00421

2 Trial Registration Date

2014-07-04

i Registration Status

Prospective

3 Secondary IDs

Protocol version 1

4 Source(s) of Funding

Department of Anaesthesia and Intensive Care, Tuen Mun Hospital; Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

5 Primary Sponsor

CUHK

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, Prince of Wales Hospital, The Chinese University of Hong Kong

iii Phone

26322736

iv Email

mtvchan@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

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

i Name

Dr Cramen Lam

ii Address

c/-Department of Anaesthesia and Intensive Care, Tuen Mun Hospital,

iii Phone

2468 5600

iv Email

carmenlam1013@gmail.com

v Affiliation

Tuen Mun Hospital

vi Country

9 Official Scientific Title of the Study

Prospective Randomized Double-blinded controlled study of Continuous Pre-peritoneal Infusion of Local Anaesthetic (PP LA) Ropivacaine, in addition to Intravenous Patient Control Analgesia (IV PCA) Morphine on patients undergoing Liver Resection in our local population

10 Public Title

Wound Catheter study

i Public Title in Chinese 研究名稱

比較切口”持續輸注局部麻醉藥”羅哌卡因 (LA Ropivavaine), 對肝藏切除術後使用嗎啡”病人自控止痛術”(IV PCA Morphine)之止痛成效及副作用之影響

11 Short Title (Optional)

N/A

12 Countries of Recruitment

Hong Kong SAR

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2010-12-14

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Liver resection

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Continuous Pre-peritoneal Infusion of Local Anaesthetic

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

48 hours after surgery

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Saline infusion

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

1. scheduled to undergo elective liver resection
2. given IV PCA Morphine as post-operative analgesia
3. aged 18 to 80 years

ii Exclusion Criteria

1. Drug allergy to morphine and ropivacaine
2. Chronic pain patients
3. Preoperative opioid consumption
4. Preoperative cognitive dysfunction
5. Psychiatric disorders
6. Inability to use the PCA device
7. Severe chronic obstructive airway disease
8. Perioperative massive bleeding with hemodynamic instability
9. Patients’ refusal

iii Age Minimum

18

iv Age Maximum

80

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

iii Degree of masking

Double-blind

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

2014-08-01

21 Target Sample Size

42

22 Recruitment Status

Unknown

23 Primary Outcome

Morphine consumption during the first 72 hours after surgery

24 Secondary Outcome

Pain score
Postoperative nausea and vomiting
Patient staisfaction

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-08-05

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-14004890

28 Date of Registration in Primary Registry

2014-07-04

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Trial Detail