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Clinical Trials/NCT03570645
NCT03570645
Completed
Phase 4

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

China Medical University, China1 site in 1 country154 target enrollmentJuly 12, 2019

Overview

Phase
Phase 4
Intervention
Dexmedetomidine Group
Conditions
Lung Cancer
Sponsor
China Medical University, China
Enrollment
154
Locations
1
Primary Endpoint
Change of thoracic paravertebral block analgesia duration
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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

Detailed 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.

Registry
clinicaltrials.gov
Start Date
July 12, 2019
End Date
November 18, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Wen-fei Tan

Professor

China Medical University, China

Eligibility Criteria

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.

Arms & Interventions

dexmedetomidine group

thoracic paravertebral blocks using a combination of ropivacaine and dexmedetomidine 100 ug every time

Intervention: Dexmedetomidine Group

dexamethasone Group

thoracic paravertebral blocks using a combination of ropivacaine and dexamethasone 10 mg every time

Intervention: dexamethasone group

control group

thoracic paravertebral blocks using only ropivacaine

Intervention: control group

Outcomes

Primary Outcomes

Change of thoracic paravertebral block analgesia duration

Time Frame: Change from Baseline to 2 days after surgery

The prime outcomes were the time in minutes from leave the postoperative care unit to the first patient-controlled intravenous analgesia press

Secondary Outcomes

  • blood concentrations of ropivacaine(Change from Baseline to 2 days after surgery)

Study Sites (1)

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