CCRB Logo

Trial History Detail on 2019-08-08

CUHK_CCT00391

2014-01-22

Prospective

CRE-2013.637-T

Department resources (The Department of Anesthesia and Intensive Care)

Prof Karmakar at the Department of Anesthesia and Intensive Care

Nil

Not Applicable

Winnie Samy

Department of Anesthesia and Intensive Care

26323155

wsamy@cuhk.edu.hk

Department of Anesthesia and Intensive Care

Hong Kong SAR, China

Manoj K Karmakar

Department of Anesthesia and Intensive Care

26322737

karmakar@cuhk.edu.hk

Department of Anesthesia and Intensive Care

HK SAR China

Multi-level Thoracic Paravertebral Block and Its Effects on Acute and Chronic Pain, and Health-Related Quality of Life after Major Breast Cancer Surgery. Changed to new title in 2018 as: Thoracic Paravertebral Block and the Risk of Developing Chronic Pain after Major Breast Cancer Surgery. A Prospective Randomized Study Comparing a Single-level versus Multi-level Thoracic Paravertebral Block

Thoracic Paravertebral Block and the Risk of Developing Chronic Pain after Major Breast Cancer Surgery. A Prospective Randomized Study Comparing a Single-level versus Multi-level Thoracic Paravertebral Block

前瞻性隨機對照單平面和多平面胸椎旁阻滯對乳腺癌術後慢性疼痛發生的風險研究

Multi-level Thoracic Paravertebral Block and quality of life

Hong Kong SAR, China

Yes

2014-01-20

Joint CUHK-NTEC Clinical Research Ethics Committee

2013.637-T

Breast cancer in females

Procedure

Ultrasound guided multi-level thoracic paravertebral nerve block

not pharmaceutical study

not pharmaceutical study

30 minutes

once

In this study, there are two study groups. In both groups three injections will be made in the back. In one group, local anesthetic will be injected in all the three levels; while in the other group, local anesthetic will be injected in one thoracic level and saline will be injected subcutaneously or intramuscularly in the other two levels. You will be assigned to one of the two groups randomly. There is 50:50 chance of each group 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 whole procedure will last approximately 20-30 minutes.

not pharmaceutical study

not pharmaceutical study

30 minutes

once

Consenting adult ASA 1-3 patients under the age of 70 years undergoing major breast cancer surgery (which includes axillary lymph node dissection) will be recruited for this study.

The following patients will be excluded from the study: history of chronic pain, history of regular analgesic usage, contraindication to the use of non-steroidal anti-inflammatory drugs (NSAID), known allergy to local anaesthetic drugs, infection at the site of block placement, bleeding tendency or with evidence of coagulopathy, pre-existing neurological or muscular disorders, history of psychiatric illness, pregnant patients, pre-existing nausea or vomiting, patients who received opioid or drugs with antiemetic properties in the 24 h before surgery, patients who received chemotherapy or radiotherapy before surgery and patients with breast pain before surgery.

30

70

Female

Interventional

Randomized

Double blinded

Active

Double-blind

Parallel

4

2014-06-27

220

Recruiting

The incidence of chronic pain at 3 months, 6 months, 1 year, 2 year, 3 year, 4 year, and 5 year after the surgery will be recorded.

Total Additional Dose of Morphine administered during the surgery will be recorded; The pain score in the recovery room and the total morphine used in the recovery room will be recorded.

No

2021-08-11

ChiCTR-TRC-14004201  

2014-01-25

Type Access Document Published On  
No documents yet.
  • Page 1 of 1.