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

Phase 4

Completed

• Conditions: Lung Cancer
• Interventions: Drug: Dexmedetomidine Group; Drug: dexamethasone group; Drug: control group

• Registration Number: NCT03570645
• Lead Sponsor: China Medical University, China

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.

Study Timeline

• Study First Submitted: 2018-06-16
• Study First Submitted QC: 2018-06-16
• Study First Posted: 2018-06-27
• Study Start: 2019-07-12
• Status Verified: 2019-11
• Primary Completion: 2019-11-11
• Study Completion: 2019-11-18
• Last Update Submitted: 2019-11-18
• Last Update Posted: 2019-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dexmedetomidine group	Dexmedetomidine Group	thoracic paravertebral blocks using a combination of ropivacaine and dexmedetomidine 100 ug every time
dexamethasone Group	dexamethasone group	thoracic paravertebral blocks using a combination of ropivacaine and dexamethasone 10 mg every time
control group	control group	thoracic paravertebral blocks using only ropivacaine

Primary Outcome Measures

Name	Time	Method
Change of thoracic paravertebral block analgesia duration	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 Outcome Measures

Name	Time	Method
blood concentrations of ropivacaine	Change from Baseline to 2 days after surgery	(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.

Trial Locations

Locations (1)

Department of Anesthesiology, the First Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China