Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00625

2 Trial Registration Date

2018-10-03

i Registration Status

Prospective

3 Secondary IDs

CREC.2018.377

4 Source(s) of Funding

Department of Anaesthesia & Intensive Care, CUHK

5 Primary Sponsor

Department of Anaesthesia & Intensive Care, CUHK

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

Dept of Anaesthesia & Intensive Care
4/F Main Clinical Block & Trauma Centre
Prince of Wales Hospital
Shatin
Hong Kong

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

Prof Manoj Kumar Karmakar

ii Address

Dept of Anaesthesia & Intensive Care
4/F Main Clinical Block & Trauma Centre
Prince of Wales Hospital
Shatin
Hong Kong

iii Phone

35052735

iv Email

karmakar@cuhk.edu.hk

v Affiliation

Department of Anaesthesia & Intensive Care

vi Country

Hong Kong SAR, China

9 Official Scientific Title of the Study

Dry Tap During Real-time Ultrasound-guided Paramedian Spinal Injection with Patient in the Lateral Position: A Retrospective Review

10 Public Title

Dry Tap During Real-time Ultrasound-guided Paramedian Spinal Injection with Patient in the Lateral Position: A Retrospective Review

i Public Title in Chinese 研究名稱

not applicable, no active patient involvement, No Chinese title, Informed consent Waived

11 Short Title (Optional)

Dry Tap During Real-time Ultrasound-guided Paramedian Spinal Injection with Patient in the Lateral Position: A Retrospective Review

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?

2018-09-04

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2018.377

14 Medical Condition Being Studied

Spinal anaesthesia

15 Intervention

i Types of intervention

Other

Please specify

retrospective review

ii Description/ name of Intervention/article

Retrospective review of patients' anaesthesia records and database of real-time ultrasound guided paramedian spinal injections, performed from the non-dependent side and with the patient in lateral position over the last 10 years (2007-2017), to document the occurrence and incidence of dry tap after this technique.

iii Dosage form of the intervention

not a pharmaceutical study

iv Dosage of the intervention

not a pharmaceutical study

v Duration of the intervention

no active intervention will be done on patients.Data collection from patient records

vi Frequency of the intervention

Collect data from patients' records once

16 Comparative Treatments

i Description/ name of comparative treatments

N/A. Retrospective Review, no comparison will be done

ii Dosage form of the comparative treatments

not applicable

iii Dosage of the comparative treatments

not applicable

iv Duration of the comparative treatments

not applicable

v Frequency of the comparative treatments

not applicable

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Archived dataset of all adult patients who had undergone real-time ultrasound guided paramedian spinal anesthesia or Combined spinal epidural, from the non-dependent side and with the patient in lateral position, for surgical anesthesia during orthopaedics, lower abdominal, urogenital and gynaecological surgery will be retrieved for this retrospective review.

ii Exclusion Criteria

Patients with spinal deformity (Scoliosis), operated or instrumented backs

iii Age Minimum

18

iv Age Maximum

100

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

2018-10-15

21 Target Sample Size

estimate 150 cases

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

incidence of dry tap (retrieved from patient records)

ii The metric or method of measurement used

failure of cerebrospinal fluid (CSF) efflux from the hub of spinal needle

iii The timepoint(s) of primary interest

more than 3 minutes with the tip of spinal needle visualized sonographically within the subarachnoid space (this data will be collected from records once only)

24 Secondary Outcome

i The Name of the outcome

slow cerebrospinal fluid (CSF) efflux [retrieved from patient records]

ii The metric or method of measurement used

efflux of CSF within 1 to 3 minutes after the removal of spinal needle stylet with the needle tip visualized sonographically within the subarachnoid space.

iii The timepoint(s) of primary interest

within 1 to 3 minutes of the removal of spinal needle stylet (this data will be collected once only)

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2019-08-08

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

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Trial History Detail on 2018-10-03