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

NCT03570645 | Completed Phase 4 DMC

• 1 other identifier: 20180616
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• blood concentrations of ropivacaine

  Change from Baseline to 2 days after surgery

Study Arms (3)

dexmedetomidine group

EXPERIMENTAL

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

Drug: Dexmedetomidine Group

dexamethasone Group

EXPERIMENTAL

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

Drug: dexamethasone group

control group

SHAM COMPARATOR

thoracic paravertebral blocks using only ropivacaine

Drug: control group

Interventions

Dexmedetomidine Group DRUG

combination of ropivacaine and dexmedetomidine 100 ug every time

dexmedetomidine group

dexamethasone group DRUG

combination of ropivacaine and dexamethasone 10mg every time

dexamethasone Group

control group DRUG

block with only ropivacaine

control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) age 18 to 65 years,
• (2) scheduled to undergo video-assisted thoracic surgery,
• (3) American Society of Anesthesiologists risk classification I-II.

You may not qualify if:

• (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.

Sponsors & Collaborators

• China Medical University, China: lead

Study Sites (1)

Department of Anesthesiology, the First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: thoracic paravertebral blocks using a combination of ropivacaine and dexmedetomidine or dexamethasone

Study Record Dates

• First Submitted: June 16, 2018
• First Posted: June 27, 2018
• Study Start: July 12, 2019
• Primary Completion: November 11, 2019
• Study Completion: November 18, 2019
• Last Updated: November 20, 2019

Record last verified: 2019-11

Locations

CN (1)