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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03570645
Other study ID # 20180616
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date July 12, 2019
Est. completion date November 18, 2019

Study information

Verified date November 2019
Source China Medical University, China
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study was a prospective, randomized, controlled, and double-blind trial. Major assessments were made during the operation and 48 h postoperatively.


Description:

The prime outcomes were the time in minutes from leave the postoperative care unit to the first patient-controlled intravenous analgesia press.The secondary outcomes were to compare the following: (1)blood concentrations of ropivacaine was measured at 0.5 h, 1 h, 2 h, 3 h, and 24 h after paravertebral nerve block; and (2) the patient's intraoperative opioid use, phenylephrine use, fluid intake, urine output, dry mouth score, and 24 h and 48 h visual analogue scale.


Recruitment information / eligibility

Status Completed
Enrollment 154
Est. completion date November 18, 2019
Est. primary completion date November 11, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- (1) age 18 to 65 years,

- (2) scheduled to undergo video-assisted thoracic surgery,

- (3) American Society of Anesthesiologists risk classification I-II.

Exclusion Criteria:

- (1) patient refusal;

- (2) known hypersensitivity to the study medication (ropivacaine);

- (3) long-term use of opioids;

- (4) liver or renal insufficiency;

- (5) a history of psychiatric or neurological disease;

- (6) deafness;

- (7) regular use of acetaminophen, nonsteroidal anti-inflammatory drugs, corticosteroids, or antiemetics; and

- (8) a preoperative Pittsburgh Sleep Quality Index (PSQI) global score higher than 6.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dexmedetomidine Group
combination of ropivacaine and dexmedetomidine 100 ug every time
dexamethasone group
combination of ropivacaine and dexamethasone 10mg every time
control group
block with only ropivacaine

Locations

Country Name City State
China Department of Anesthesiology, 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 Change of thoracic paravertebral block analgesia duration The prime outcomes were the time in minutes from leave the postoperative care unit to the first patient-controlled intravenous analgesia press Change from Baseline to 2 days after surgery
Secondary blood concentrations of ropivacaine (The secondary outcomes were to compare the following: (1)blood concentrations of ropivacaine was measured at 0.5 h, 1 h, 2 h, 3 h, and 24 h after paravertebral nerve block; and (2) the patient's intraoperative opioid use, phenylephrine use, fluid intake, urine output, dry mouth score, and 24 h and 48 h visual analogue scale. Change from Baseline to 2 days after surgery
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