Lung CancerPhase 4NCT03570645
Comparison of the Duration of Ropivacaine Combined With Dexmedetomidine or Dexamethasone on Paravertebral Block
A Phase 4 study testing Dexmedetomidine Group and dexamethasone group in people with Lung Cancer, run by China Medical University, China at 1 site in China.
Trial summary
This study was a prospective, randomized, controlled, and double-blind trial. Major assessments were made during the operation and 48 h postoperatively. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Dexmedetomidine Group and dexamethasone group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 1 siteChina
- Study dates
- 12 Jul 2019to 18 Nov 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) age 18 to 65 years,
- (2) scheduled to undergo video-assisted thoracic surgery,
- (3) American Society of Anesthesiologists risk classification I-II.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesiology, the First Hospital of China Medical University
Shenyang, Liaoning, 110001
About this study
Official title: Comparison of the Duration of Ropivacaine Combined With Dexmedetomidine or Dexamethasone on Paravertebral Block in Patients Undergoing Video-assisted Thoracic Surgery
This study was a prospective, randomized, controlled, and double-blind trial. Major assessments were made during the operation and 48 h postoperatively.
Read the 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
- Being tested
- Dexmedetomidine Group, dexamethasone group, control group
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine GroupDrug
combination of ropivacaine and dexmedetomidine 100 ug every time
dexamethasone groupDrug
combination of ropivacaine and dexamethasone 10mg every time
control groupDrug
block with only ropivacaine
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine group | Experimental | thoracic paravertebral blocks using a combination of ropivacaine and dexmedetomidine 100 ug every time Receives: Drug: Dexmedetomidine Group |
| dexamethasone Group | Experimental | thoracic paravertebral blocks using a combination of ropivacaine and dexamethasone 10 mg every time Receives: Drug: dexamethasone group |
| control group | Sham comparator | thoracic paravertebral blocks using only ropivacaine Receives: Drug: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from Baseline to 2 days after surgery
Secondary outcomes (1)
blood concentrations of ropivacaine
(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.
Measured: Change from Baseline to 2 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start12 Jul 2019
- Primary completion11 Nov 2019
- Study completion18 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- thoracic paravertebral blocks using a combination of ropivacaine and dexmedetomidine or dexamethasone
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-fei Tan, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03570645
- Sponsor's protocol ID
- 20180616
- Status last verified
- Nov 2019
- First submitted
- 16 Jun 2018
- Last updated
- 20 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Duration of Ropivacaine Combined With Dexmedetomidine or Dexamethasone on Paravertebral Block in Patients Undergoing Video-assisted Thoracic Surgery
- ClinicalTrials.gov ID
- NCT03570645
- Acronym / sponsor ID
- 20180616
- Conditions
- Lung Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Study start
- 12 Jul 2019 (actual)
- Primary completion
- 11 Nov 2019 (actual)
- Study completion
- 18 Nov 2019 (actual)
- First posted
- 27 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- thoracic paravertebral blocks using a combination of ropivacaine and dexmedetomidine or dexamethasone
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine group | Experimental | Drug: Dexmedetomidine Groupthoracic paravertebral blocks using a combination of ropivacaine and dexmedetomidine 100 ug every time |
| dexamethasone Group | Experimental | Drug: dexamethasone groupthoracic paravertebral blocks using a combination of ropivacaine and dexamethasone 10 mg every time |
| control group | Sham comparator | Drug: control groupthoracic paravertebral blocks using only ropivacaine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- (1) age 18 to 65 years,
- (2) scheduled to undergo video-assisted thoracic surgery,
- (3) American Society of Anesthesiologists risk classification I-II.
Key exclusion criteria (8 listed)
- (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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidine Groupcombination of ropivacaine and dexmedetomidine 100 ug every time | Drug | dexmedetomidine group |
| dexamethasone groupcombination of ropivacaine and dexamethasone 10mg every time | Drug | dexamethasone Group |
| control groupblock with only ropivacaine | Drug | control group |
Primary outcome
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
1 secondary outcome
blood concentrations of ropivacaine
Time frame: Change from Baseline to 2 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine Group and dexamethasone group in people with Lung Cancer, run by China Medical University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of thoracic paravertebral block analgesia duration (time frame: Change from Baseline to 2 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2019.