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Trial History Detail on 2016-04-01

CUHK_CCRB00493

2015-12-04

Prospective

CREC. 2015.209-T

Dept of Anaethesia & Intensive Care, CUHK

Dept of Anaethesia & Intensive Care, CUHK

nil

Not Applicable

Winnie Samy

Dept of Anaethesia & Intensive Care
Prince of Wales Hospital
CUHK

26322735

wsamy@cuhk.edu.hk

research nurse

Hong Kong

Prof. Manoj Kumar Karmakar

Dept of Anaethesia & Intensive Care
Prince of Wales Hospital
CUHK

2632 2735

karmakar@cuhk.edu.hk

Professor

Hong Kong

The minimum effective volume of 0.5% Ropivacaine for ultrasound-guided Infraclavicular Brachial Plexus Block (USG ICBPB)using the costoclavicular Approach

The minimum effective volume of 0.5% Ropivacaine for ultrasound-guided Infraclavicular Brachial Plexus Block (USG ICBPB)using the costoclavicular Approach

超聲波引導從肋鎖間的鎖骨下窩臂叢神經阻滯中0.5%羅呱卡因的最小有效麻醉容量

nil

Hong Kong

Yes

2015-07-20

Joint CUHK-NTEC Clinical Research Ethics Committee

CREC.2015.209-T

musculoskeletal system and connective tissue

Drug

This study will determine what the minimum effective volume (MEV) of 0.5% ropivacaine is for 90% patients receiving the costoclavicular approach (CC) of Infraclavicular brachial plexus block (ICBPB). Study subjects will be randomized based on ‘biased coin design’ method. Since the MEAV90 of 0.5% Ropivacaine for the CC approach of ICBPB is not known, the initial volume that will be used will be 25 mL based on our clinical experience. Depending on the success or failure of brachial plexus blockade to the previous volume, the volume for the next patient will be adjusted up or down by 2mL. For example, if the block is successful in the previous patient, the next subject will be randomized to a lower volume (89% chances) or to an identical volume (11% chances). In the case of failure, the next patient receives a higher volume.

10-30 ml of 0.5% ropivacaine

0.5% ropivacaine

3 hours

once

Not applicable

not applicable

not applicable

not applicable

not applicable

Patients of American Society of Anesthesiologists (ASA) physical status I-II, who are aged between 20 to 70 years and scheduled to undergo elective forearm or hand surgery, unrelated to trauma, under brachial plexus block will be prospectively enrolled

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

20

70

Both Male and Female

Interventional

Randomized

Prospective, randomized and dose-ranging study

Dose comparison

Single-blind

Trial subjects

Not Applicable

Other

drug is widely used clinically

To estimate the minimum effective anaesthetic volume (MEAV) of 0.5% Ropivacaine required to produce surgical anaesthesia during an USG ICBPB using teh costoclavicular approach in 90% of patients

2016-03-01

45

Not Yet Recruiting

Volume of 0.5% ropivacaine, sensory and motor function, rescue volume of 0.5% ropivacaine, rescue analgesia

3 point scale: 0=no block, 1=analgesia; 2=anesthesia for senory & motor function assessment

from ICBPB to the end of surgery (approximately 3 hours)

duration of performing the block, incidence of paresthesia, degree of discomfort, duration of surgery

verbal rating scale 0-100 for discomfort/pain,

from ICBPB to the end of surgery (approximately 3 hours)

No

2019-02-11

ChiCTR-IOR-15007515

2015-12-04

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