Sleep Quality After Stellate-ganglion Block of Patients Undergoing Breast Cancer Operation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Sleep Quality After Stellate-ganglion Block of Patients Undergoing Breast Cancer Operation

Conditions
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Sleep Deprivation

Intervention / Treatment
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* Drug: 0.25% ropivacaine hydrochloride
* Drug: saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least18 years and pre-menopausal; scheduled to undergo elective breast cancer operation; American Society of Anaesthesiologists (ASA) risk classification I-II. Exclusion Criteria: (1) patient refusal; (2) known hypersensitivity to the study medication (ropivacaine); (3) long-term use of opioids; (4) a history of psychiatric or neurological disease; (5) a preoperative Pittsburgh Sleep Quality Index (PSQI) global score higher than 6.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control<br>All patients undergoing breast cancer operation will be the treatment intervention with general anesthesia as an adjunct to stellate-ganglion block with saline. | Drug: saline<br>* stellate-ganglion block with saline<br>|
| Experimental: stellate-ganglion block<br>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. | Drug: 0.25% ropivacaine hydrochloride<br>* stellate-ganglion block with 0.25% ropivacaine hydrochloride<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bispectral index, regional cerebral oxygen saturation, Stellate-ganglion block