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

NCT ID: NCT03570645

Last Updated: 2019-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-12
• Study Completion Date: 2019-11-18

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

dexmedetomidine group

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

Group Type: EXPERIMENTAL

Dexmedetomidine Group

Intervention Type: DRUG

combination of ropivacaine and dexmedetomidine 100 ug every time

dexamethasone Group

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

Group Type: EXPERIMENTAL

dexamethasone group

Intervention Type: DRUG

combination of ropivacaine and dexamethasone 10mg every time

control group

thoracic paravertebral blocks using only ropivacaine

Group Type: SHAM_COMPARATOR

control group

Intervention Type: DRUG

block with only ropivacaine

Interventions

Dexmedetomidine Group

combination of ropivacaine and dexmedetomidine 100 ug every time

Intervention Type: DRUG

dexamethasone group

combination of ropivacaine and dexamethasone 10mg every time

Intervention Type: DRUG

control group

block with only ropivacaine

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University, China

OTHER

Sponsor Role: lead

Responsible Party

Wen-fei Tan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Anesthesiology, the First Hospital of China Medical University

Shenyang, Liaoning, China

Countries

China

Other Identifiers

20180616

Identifier Type: -

Identifier Source: org_study_id