Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00609

2 Trial Registration Date

2018-05-24

i Registration Status

Prospective

3 Secondary IDs

CREC.2018.216-T

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

Rm 04A49, 4/F Main Clinical Block & Trauma Centre, Prince of Wales Hospital, Shatin, NT

iii Phone

3505 2735

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

Rm 04A49, 4/F Main Clinical Block & Trauma Centre, Prince of Wales Hospital, Shatin, NT

iii Phone

3505 2735

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

Real-time Ultrasound-guided Spinal Anaesthesia: Evaluation of a novel Transverse In-plane Technique

10 Public Title

Real-time Ultrasound-guided Spinal Anaesthesia: Evaluation of a novel Transverse In-plane Technique

i Public Title in Chinese 研究名稱

實時超聲波引導脊椎麻醉：評估使用橫向平面超聲波檢查的新技術

11 Short Title (Optional)

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?

2018-05-03

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

CREC.2018.216-T

14 Medical Condition Being Studied

Spinal anaesthesia, lower limb surgery, lower abdominal surgery, gynaecological surgery, urogenital surgery

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Spinal anaesthsia (SA) is usually performed using surface anatomical landmarks, fascial clicks and visualizing the free flow of cerebrospinal fluid (CSF). Real time ultrasound guided SA has been most frequently reported using Paramedian sagittal oblique acoustic window. However, paramedian sagittal oblique in-plane approach has limitations such as slower CSF efflux, and dry tap in the elderly possibly due to the technique being performed from non-dependent side and lower CSF pressure in the elderly. To date there are no data describing the use of transverse interspinous acoustic windows for real time ultrasound guided in-plane approach for SA from dependent side. This study will evaluate the feasibility and the technical ease of performing SA by observing the time taken for the performance of SA and the CSF efflux time using the technique of single operator, in-plane apporach from dependent side under real time ultrasound guidance in a transverse interspinous view.

iii Dosage form of the intervention

not a pharmaceutical study

iv Dosage of the intervention

not a pharmaceutical study

v Duration of the intervention

within 60 minutes

vi Frequency of the intervention

once before operation

16 Comparative Treatments

i Description/ name of comparative treatments

Not applicable. This is an observational study, so no control group to compare.

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

Patients who are between 20 to 85 years old, of American Society of Anaesthesiology (ASA) physical status classification I-III, and scheduled to undergo elective groin, lower limb, lower abdominal surgical, gynaecological and urogenital procedures under spinal anaesthesia

ii Exclusion Criteria

Patient refusal or unwilling to participate, ASA physical status >III, spinal deformity, previous spine surgery, pregnancy, coagulopathy, allergy to local anaesthetic drugs, skin infection at the site of needle insertion, severe cardiac disease such as atrial stenosis, atrial fibrillation, autonomica dysfunction, and sepsis

iii Age Minimum

20

iv Age Maximum

85

v Gender

Both Male and Female

18 Study Type

Observational

19 Study Design

i Randomization

Non-randomized

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

2018-06-01

21 Target Sample Size

30

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

Feasibility & technical ease of doing spinal anaesthesia under real time ultrasound guided transverse in-plane approach from the dependent side

ii The metric or method of measurement used

Observing the time taken for the performance of spinal anaesthesia (in minute)

iii The timepoint(s) of primary interest

once during spinal anaesthesia

Primary Outcome

i The Name of the outcome

Cerebrospinal fluid (CSF) efflux time

ii The metric or method of measurement used

The time taken for the first drop of CSF to efflux from the spinal needle hub after removal of the stylet from the spinal needle (in seconds).

iii The timepoint(s) of primary interest

once during spinal anesthesia

24 Secondary Outcome

i The Name of the outcome

Rate of successful attempt, number of spinal needle pass, patient satisfaction score, any intraoperative or postoperative complications in the next 24 hours

ii The metric or method of measurement used

successful SA defined as achieving sensor & motor blockade after SA & able to complete the surgery. Patient satisfaction score evaluated on the scale of Verbal Rating scale: 0(not satisfied) to 100 (very satisfied)

iii The timepoint(s) of primary interest

within 24 hours after Spinal Anaesthesia

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

ChiCTR1800016580

28 Date of Registration in Primary Registry

2018-05-24

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Trial History Detail on 2018-08-07