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Completed

NCT Number: NCT03570645

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

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

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Anesthesiology, the First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

dexmedetomidine group

Drug

combination of ropivacaine and dexmedetomidine 100 ug every time

Dexamethasone group

Drug

combination of ropivacaine and dexamethasone 10mg every time

Control group

Drug

block with only ropivacaine

Primary outcomes

  1. 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

  1. blood concentrations of ropivacaine

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

China Medical University, China

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 27, 2018
Registry last updated
Nov 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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