Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00565

2 Trial Registration Date

2017-09-07

i Registration Status

Prospective

3 Secondary IDs

CREC. 2014.314-T

4 Source(s) of Funding

Department of Anaesthesia & Intensive Care, PWH, CUHK

5 Primary Sponsor

Department of Anaesthesia & Intensive Care, CUHK

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Winnie Samy

ii Address

Department of Anaesthesia & Intensive Care,
4/F, Main Clinical Block & Trauma Centre
Prince of Wales Hospital
Shatin
New Territories

iii Phone

35052735

iv Email

wsamy@cuhk.edu.hk

v Affiliation

Department of Anaesthesia & Intensive Care

vi Country

Hong Kong

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

i Name

Prof Manoj Kumar Karmakar

ii Address

4/F, Main Clinical Block & Trauma Centre
Prince of Wales Hospital
Shatin
New Territories

iii Phone

852 3505 2735

iv Email

karmakar@cuhk.edu.hk

v Affiliation

Department of Anaesthesia & Intensive Care

vi Country

Hong Kong

9 Official Scientific Title of the Study

Subparaneural Sciatic Nerve Blocks Above and Below Its Bifurcation at the Popliteal Fossa: A Prospective Randomized Study

10 Public Title

Subparaneural Sciatic Nerve Blocks Above and Below Its Bifurcation at the Popliteal Fossa: A Prospective Randomized Study

i Public Title in Chinese 研究名稱

膕窩處坐骨神經分叉前和分叉下神經阻滯效果對比的前瞻隨機性研究

11 Short Title (Optional)

12 Countries of Recruitment

Hong Kong

Thailand

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2014-07-11

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2014.314-T

14 Medical Condition Being Studied

musculoskeletal disorders in the foot that require surgery

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Ultrasound guided Popliteal sciatic nerve block - subparaneural injection above or below the bifurcation

iii Dosage form of the intervention

Not a pharmaceutical study

iv Dosage of the intervention

Not a pharmaceutical study

v Duration of the intervention

1 hour

vi Frequency of the intervention

once before operation

16 Comparative Treatments

i Description/ name of comparative treatments

This is a randomized study that will recruit subjects in Hong Kong and Thailand. There is a 50:50 chance of getting either subparaneural injection above the bifurcation or below the bifurcation, which is determined by the allocation. The difference between the two methods is the onset time of the block. Injection below the bifurcation of the sciatic nerve at the popliteal fossa are expected to produce quicker block than the one above the bifurcation.

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

1 hour

v Frequency of the comparative treatments

once before operation

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Adult patients, ASA physical status I-III, aged between 18 to 75 years and scheduled to undergo elective fore foot surgery, unrelated to trauma, under regional anesthesia will be recruited

ii Exclusion Criteria

Refusal, ASA physical status > III, pregnancy, neuromuscular disorder, prior surgery int he popliteal fossa, coagulopathy, allergy to local anesthetic drugs, and skin infection at the site of needle insertion

iii Age Minimum

18

iv Age Maximum

75

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Prospective, randomized controlled trial

ii Nature of control

Active

iii Degree of masking

Not Applicable

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

4

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2017-09-11

21 Target Sample Size

70 - as per randomization sequence at the two centers

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

The sensory and motor function in the ipsilateral foot

ii The metric or method of measurement used

Sensory blockade (0-100), 100=normal sensation to cold, 0=no sensation to cold. Motor blockade (3-point scale): 2=normal, 1=paresis, 0=paralysis. Success of the block will be a complete abolition of sensation to cold & paralysis of the muscles in the calf and foot

iii The timepoint(s) of primary interest

At regular intervals for 50 minutes (5 min, 10min, 15min, 20min, 30min, 40min and 50min) after the block

24 Secondary Outcome

i The Name of the outcome

number of needle passes; any complication related to local anesthetic toxicity; any discomfort experienced by patient during injection; Local anesthetic spread after injection; size of sciatic nerve.

ii The metric or method of measurement used

Paresthesia (yes or no), & degree of discomfort (NRS: 0-100) experience by the patient during the injection. Distance (in cm) the local anesthetic has spread proximal, distal and in total; Diameter & area of sciatic nerve will be measured by using ultrasound

iii The timepoint(s) of primary interest

After the block

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2020-08-10

27 Primary Registry and Trial Identifying Number

ChiCTR-IIC-17012634

28 Date of Registration in Primary Registry

2017-09-07

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Trial History Detail on 2018-06-13