Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00420

2 Trial Registration Date

2014-07-04

i Registration Status

Prospective

3 Secondary IDs

NTWC/CREC/1126/13

4 Source(s) of Funding

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

5 Primary Sponsor

CUHK

6 Secondary Sponsor

N/A

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

2632 2736

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

Aries Tse

ii Address

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

iii Phone

2468 5472

iv Email

chuichui27@yahoo.com.hk

v Affiliation

Tuen Mun Hospital

vi Country

9 Official Scientific Title of the Study

A comparison between ultrasound guided and landmark technique in dorsal penile nerve block on improving the postoperative pain score in children undergoing elective circumcision. A randomized double-blinded controlled study

10 Public Title

Ultrasound guided dorsal penile nerve block

i Public Title in Chinese 研究名稱

比較超音波導引及體表標記陰莖背神經阻斷術用於小兒包皮環切術後隨機雙盲研究

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?

2013-07-02

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Pain after elective circumcision surgery

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Ultrasound guided dorsal penile nerve block

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

During surgery

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Traditional landmark guided dorsal penile nerve block

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

ASA 1or 2 and with age at least 5 years old who are able to self-report degree of pain, scheduled for day case circumcision

ii Exclusion Criteria

allergic to local anaesthetic, coagulopathy, and patients having an additional surgical procedure other than circumcision

iii Age Minimum

5

iv Age Maximum

18

v Gender

Male

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

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

50

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

Postoperative pain score in first 30 minutes in the recovery room using the visual analogue scale

24 Secondary Outcome

1) Total dose of fentanyl used intra and postoperatively;
2) Side effects from opioid use eg. nausea/ vomiting/ pruritus/ sedation/ urinary retention;
3) Duration of stay in the recovery room;
4) Time to perform the block;
5) Duration of theatre time (from anesthetic induction to emergence).
6) Number of failed nerve block (pain score>5 on arrival to recovery);
7) Complication rate (bruising, haematoma formation, skin sloughing, infection) associated with DPNB

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-14004889

28 Date of Registration in Primary Registry

2014-07-04

* Legacy Fields

i Recruitment Information Available?

No

ii Link to Recruitment Information

N/A

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Trial History Detail on 2014-07-07