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

Sleep Deprivation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02651519
• Other study ID #: 2015110302
• Status: Completed
• Phase: Phase 4
• First received: January 5, 2016
• Last updated: March 23, 2017
• Start date: January 2016
• Est. completion date: September 2016

Study information

• Verified date: January 2016
• Source: China Medical University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ganglion Cysts
• Sleep Deprivation

Intervention

Drug:
• 0.25% ropivacaine hydrochloride
stellate-ganglion block with 0.25% ropivacaine hydrochloride
• saline
stellate-ganglion block with saline

Locations

Country	Name	City	State
China	the First Hospital of China Medical University	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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