Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Stellate-ganglion block have been done safely for more than 60 years. It has proved to provide survivors of breast cancer with relief from hot flushes and sleep dysfunction with few or no side-effects. The aim of the present study is to evaluate postoperative sleep quality of patients undergoing breast cancer surgery with Stellate-ganglion block performed in the operation.
This study is a prospective, randomized, controlled (randomized, parallel group, concealed allocation), double-blinded trial. All patients undergoing breast cancer operation will be randomized 1:1 to the treatment intervention with general anesthesia as an adjunct to Stellate-ganglion block with 0.25% ropivacaine hydrochloride or saline. The objective of the trial is to evaluate the postoperative sleep quality of patients undergoing breast cancer operation with Stellate-ganglion block 0.25% ropivacaine hydrochloride or saline.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Sham Comparator | All patients undergoing breast cancer operation will be the treatment intervention with general anesthesia as an adjunct to stellate-ganglion block with saline. |
|
| stellate-ganglion block | Experimental | All patients undergoing breast cancer operation will be the treatment intervention with general anesthesia as an adjunct to stellate-ganglion block with 0.25% ropivacaine hydrochloride. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.25% ropivacaine hydrochloride | Drug | stellate-ganglion block with 0.25% ropivacaine hydrochloride |
|
| Measure | Description | Time Frame |
|---|---|---|
| sleep quality | The primary objective is to compare postoperative sleep quality, as measured using a bispectral index-Vista monitor during the first night after surgery. | first postoperative night |
| Measure | Description | Time Frame |
|---|---|---|
| regional cerebral oxygen saturation | physiological parameter of regional cerebral oxygen saturation of all patients during the operation will be recorded.Regional cerebral oxygen saturation measured by near-infrared spectroscopy in the frontal lobe has been used previously to evaluate overall cerebral blood flow. The normal range of cerebral oxygen saturation is 55-80%. | In the operation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Wen-fei Tan, PhD,MD | First Hospital of China Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Hospital of China Medical University | Shenyang | Liaoning | 110001 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29043600 | Derived | Jin F, Li XQ, Tan WF, Ma H, Fang B, Tian AY, Lu HW. Effects of ultrasound-guided stellate-ganglion block on sleep and regional cerebral oxygen saturation in patients undergoing breast cancer surgery: a randomized, controlled, double-blinded trial. J Clin Monit Comput. 2018 Oct;32(5):855-862. doi: 10.1007/s10877-017-0074-3. Epub 2017 Oct 17. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012892 | Sleep Deprivation |
| ID | Term |
|---|---|
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| saline | Drug | stellate-ganglion block with saline |
|
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D000588 |
| Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |