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

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

Sponsors

Lead Sponsor: China Medical University, China

Source China Medical University, China
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.

Overall Status Completed
Start Date January 2016
Completion Date September 2016
Primary Completion Date September 2016
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
sleep quality first postoperative night
Secondary Outcome
Measure Time Frame
regional cerebral oxygen saturation In the operation
Enrollment 105
Condition
Intervention

Intervention Type: Drug

Intervention Name: 0.25% ropivacaine hydrochloride

Description: stellate-ganglion block with 0.25% ropivacaine hydrochloride

Arm Group Label: stellate-ganglion block

Intervention Type: Drug

Intervention Name: saline

Description: stellate-ganglion block with saline

Arm Group Label: Control

Eligibility

Criteria:

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.

Gender: Female

Minimum Age: 18 Years

Maximum Age: 55 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Wen-fei Tan, PhD,MD Principal Investigator First Hospital of China Medical University
Location
Facility: the First Hospital of China Medical University
Location Countries

China

Verification Date

January 2016

Responsible Party

Type: Principal Investigator

Investigator Affiliation: China Medical University, China

Investigator Full Name: Wen-fei Tan

Investigator Title: associate proffessor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Control

Type: Sham Comparator

Description: All patients undergoing breast cancer operation will be the treatment intervention with general anesthesia as an adjunct to stellate-ganglion block with saline.

Label: stellate-ganglion block

Type: Experimental

Description: 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.

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

Source: ClinicalTrials.gov