Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00388

2 Trial Registration Date

2014-01-21

i Registration Status

Prospective

3 Secondary IDs

CRE-2013.552

4 Source(s) of Funding

Department resources (The Department of Anesthesia and Intensive Care)

5 Primary Sponsor

Prof Karmakar at The Department of Anesthesia and Intensive Care

6 Secondary Sponsor

Nil

Function

Please specify

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

i Name

Winnie Samy

ii Address

Department of Anesthesia and Intensive Care

iii Phone

26323155

iv Email

wsamy@cuhk.edu.hk

v Affiliation

Department of Anesthesia and Intensive Care

vi Country

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

i Name

Manoj K Karmakar

ii Address

Department of Anesthesia and Intensive Care

iii Phone

26322737

iv Email

karmakar@cuhk.edu.hk

v Affiliation

Department of Anesthesia and Intensive Care

vi Country

9 Official Scientific Title of the Study

Does Circumferential Spread of Local Anaesthetic Shorten the Onset of Sensory-Motor Blockade after a Subparaneural Popliteal Sciatic Nerve Block ?

10 Public Title

Does Circumferential Spread of Local Anaesthetic Shorten the Onset of Sensory-Motor Blockade after a Subparaneural Popliteal Sciatic Nerve Block ?

i Public Title in Chinese 研究名稱

腘窩處坐骨神經旁膜下註射局部麻醉藥物後環形擴散是否可以加快感覺-運動神經阻滯？

11 Short Title (Optional)

Circumferential spread during the sciatic nerve block

12 Countries of Recruitment

China

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2013-12-27

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Musculoskeletal disorders in foot which require surgery

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Ultrasound guided sciatic nerve block at the popliteal fossa

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

60 minutes

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

This is a randomized study and there is a 50:50 chance of getting either single injection or two injections which is determined by the allocation. In the group of two injections, the local anesthetic will spread circumferentially surrounding the nerve. The difference between the two methods is the onset time of the block. Two injections are expected to produce quicker block than the single injection.

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

70 adult patients, ASA physical statusⅠ-Ⅲ, aged between 18 to 75 years and scheduled to undergo elective fore foot surgery, unrelated to trauma, under regional anesthesia will be enrolled.

ii Exclusion Criteria

Patient refusal, ASA physical status > Ⅲ, pregnancy, neuromuscular disorder, prior surgery in the popliteal fossa, coagulopathy, allergy to local anesthetic drugs, and skin infection at the site of needle insertion will be excluded.

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

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

2014-02-12

21 Target Sample Size

70

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

Onset time of sensory block in the tibial nerve and common peroneal nerve. The sensory and motor function in the ipsilateral foot will also be evaluated by an independent observer (research nurse) at regular intervals for 50 minutes (5 min, 10 min, 20 min, 30min, 40 min and 50 min) after the sciatic nerve block.

24 Secondary Outcome

The incidence of paresthesia, abnormal sensation and motor weakness will be followed up at 1 week and 1 month after the surgery

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2020-03-30

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-14004198

28 Date of Registration in Primary Registry

2014-01-25

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2014-01-28