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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02651519

Enrollment

105

Registered

2016-01-11

Start date

2016-01-31

Completion date

2016-09-30

Last updated

2017-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Deprivation

Keywords

bispectral index, regional cerebral oxygen saturation, Stellate-ganglion block

Brief summary

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

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.

Interventions

DRUG0.25% ropivacaine hydrochloride

stellate-ganglion block with 0.25% ropivacaine hydrochloride

DRUGsaline

stellate-ganglion block with saline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 55 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
sleep quality	first postoperative night	The primary objective is to compare postoperative sleep quality, as measured using a bispectral index-Vista monitor during the first night after surgery.

Secondary

Measure	Time frame	Description
regional cerebral oxygen saturation	In the operation	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%.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026