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Trial History Detail on 2018-06-13

CUHK_CCRB00565

2017-09-07

Prospective

CREC. 2014.314-T

Department of Anaesthesia & Intensive Care, PWH, CUHK

Department of Anaesthesia & Intensive Care, CUHK

N/A

Not Applicable

Winnie Samy

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

35052735

wsamy@cuhk.edu.hk

Department of Anaesthesia & Intensive Care

Hong Kong

Prof Manoj Kumar Karmakar

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

852 3505 2735

karmakar@cuhk.edu.hk

Department of Anaesthesia & Intensive Care

Hong Kong

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

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

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

Hong Kong

Thailand

Yes

2014-07-11

Joint CUHK-NTEC Clinical Research Ethics Committee

2014.314-T

musculoskeletal disorders in the foot that require surgery

Procedure

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

Not a pharmaceutical study

Not a pharmaceutical study

1 hour

once before operation

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.

Not a pharmaceutical study

Not a pharmaceutical study

1 hour

once before operation

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

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

18

75

Both Male and Female

Interventional

Randomized

Prospective, randomized controlled trial

Active

Not Applicable

Parallel

4

2017-09-11

70 - as per randomization sequence at the two centers

Recruiting

The sensory and motor function in the ipsilateral foot

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

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

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.

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

After the block

No

2020-08-10

ChiCTR-IIC-17012634

2017-09-07

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