Comparison of the Duration of Ropivacaine Combined With Dexmedetomidine or Dexamethasone on Paravertebral Block

Lung Cancer Clinical Trial

Official title:

Comparison of the Duration of Ropivacaine Combined With Dexmedetomidine or Dexamethasone on Paravertebral Block in Patients Undergoing Video-assisted Thoracic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03570645
• Other study ID #: 20180616
• Status: Completed
• Phase: Phase 4
• 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
• 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.

Related Conditions & MeSH terms

• Lung Cancer

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