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

C

China Medical University, China

Status and phase

Completed
Phase 4

Conditions

Sleep Deprivation

Treatments

Drug: saline
Drug: 0.25% ropivacaine hydrochloride

Study type

Interventional

Funder types

Other

Identifiers

NCT02651519
2015110302

Details and patient eligibility

About

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.

Full 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.

Enrollment

105 patients

Sex

Female

Ages

18 to 55 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

105 participants in 2 patient groups

Control
Sham Comparator group
Description:
All patients undergoing breast cancer operation will be the treatment intervention with general anesthesia as an adjunct to stellate-ganglion block with saline.
Treatment:
Drug: saline
stellate-ganglion block
Experimental group
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.
Treatment:
Drug: 0.25% ropivacaine hydrochloride

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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