Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00390

2 Trial Registration Date

2014-01-22

i Registration Status

Prospective

3 Secondary IDs

CRE-2013.497-T

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

Pectoral nerve block to supplement a multi-level thoracic paravertebral block for surgical anesthesia during major breast cancer surgery: A prospective randomized double blind study

10 Public Title

Pectoral nerve block to supplement a multi-level thoracic paravertebral block for surgical anesthesia during major breast cancer surgery: A prospective randomized double blind study

i Public Title in Chinese 研究名稱

胸肌神經輔助多平面胸椎旁阻滯對乳腺癌手術麻醉的前瞻性隨機雙盲研究

11 Short Title (Optional)

Pectoral nerve block for multi-level thoracic paravertebral 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?

2014-01-17

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Breast Cancer in females

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Ultrasound guided multi-level thoracic paravertebral nerve block and pectoral nerve block

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

50 minutes

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

There will be two kinds of fluid injected for pectoral nerve, A & B, A = saline (group of without pectoral nerve block), B = local anesthetic (group of with pectoral nerve block). There is 50:50 chance of getting either drug which is determined by the allocation. No matter which drug is used, it will not affect your surgery because rescue analgesia will be administered whenever necessary during the surgery. The group of local anesthetic injection is expected to provide better analgesia in combination with multi-level thoracic paravertebral nerve block for breast cancer surgery.

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

60 adult patients, ASA physical status Ⅰ-Ⅲ, aged between 30 to 80 years and scheduled to undergo modified radical mastectomy (MRM) or mastectomy with sentinel lymph node biopsy will be recruited for this study.

ii Exclusion Criteria

Patient refusal, ASA physical status > Ⅲ, BMI > 35kg/m2, spinal deformity, previous spine surgery, pregnancy, coagulopathy, allergy to local anesthetic drugs, and skin infection at the site of needle insertion will be excluded.

iii Age Minimum

30

iv Age Maximum

80

v Gender

Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

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

2014-02-28

21 Target Sample Size

60

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

The midazolam, dexmedetomidine, ketamine, and other rescue analgesic used during the surgery will be recorded.

24 Secondary Outcome

Pain at rest and on movement on the surgery site will be assessed in the recovery room. Before discharge from the recovery room, the motor power grade of the pectoral major and minor muscles supplied by pectoral nerve and 4 nerves of the brachial plexus as injection is close to the brachial plexus will be assessed. In the ward, the pain score, nausea score, supplementary paracetemol, morphine and ondestron used will be recorded at regular intervals in the ward for 48 hours.

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

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2014-01-22