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Trial History Detail on 2014-01-28

CUHK_CCT00390

2014-01-22

Prospective

CRE-2013.497-T

Department resources (The Department of Anesthesia and Intensive Care)

Prof Karmakar at the Department of Anesthesia and Intensive Care

Nil

Winnie Samy

Department of Anesthesia and Intensive Care

26323155

wsamy@cuhk.edu.hk

Department of Anesthesia and Intensive Care

Manoj K Karmakar

Department of Anesthesia and Intensive Care

26322737

karmakar@cuhk.edu.hk

Department of Anesthesia and Intensive Care

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

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

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

Pectoral nerve block for multi-level thoracic paravertebral block

China

Yes

2014-01-17

Breast Cancer in females

Procedure

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

50 minutes

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.

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.

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.

30

80

Female

Interventional

Randomized

Placebo

Double-blind

Parallel

2014-02-28

60

Not Yet Recruiting

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

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.

No

2020-03-30

ChiCTR-TRC-14004200

2014-01-25


Yes

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