Lung CancerNCT03449563

Effects of Open Thoracic Paravertebral Block on Postoperative Analgesia

A study testing Open TPVB and Ultrasound-guided TPVB in people with Lung Cancer, run by Kunming Medical University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 35 to 75 years
Conditions the study is for: Lung Cancer
What is being tested?: Open TPVB and Ultrasound-guided TPVB
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 90 participants
Where: No sites listed yet
Study dates: 1 Sep 2016to 28 Dec 2017
Phase: Interventional
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 35 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

with American Society of Anesthesiologists physical status Ⅰor Ⅱ
aged 35 - 75 years old
with body mass index of 20 - 25 kg／m2,
scheduled for open pulmonary lobectomy under general anaesthesia at the First Affiliated Hospital of Kunming Medical University

Who cannot join

cardiovascular and/or cerebrovascular disease;
diabetes; pre-existing liver, lung or kidney dysfunction;
bilateral surgery; take operations again within 48 h after the surgery;
with serious pulmonary infection and coagulation dysfunction

About this study

Official title: Effects of Open Thoracic Paravertebral Block on Postoperative Analgesia in Patients Undergoing Open Pulmonary Lobectomy

The study was aimed to assess the effects of open thoracic paravertebral block on postoperative analgesia in patients undergoing open pulmonary lobectomy under general anesthesia. Then, A total of 90 patients with American Society of Anesthesiologists (ASA) scores of Ⅰ or Ⅱ, scheduled for open pulmonary lobectomy under propofol - remifentanil total intravenous anaesthesia, were randomly divided into PCIA group (group G), Ultrasound-guided TPVB combined with PCIA group (group U), and open TPVB combined with PCIA group (group E).Finally, the study find that Open TPVB can provided satisfactory analgesia for patients undergoing open pulmonary lobectomy under general anesthesia, and the analgesia efficacy was equivalent to the TPVB under ultrasound guidance,which should be popularized.

Read the detailed description

Purpose: The study was aimed to assess the effects of open thoracic paravertebral block on postoperative analgesia in patients undergoing open pulmonary lobectomy under general anesthesia.

Methods: A total of 90 patients with American Society of Anesthesiologists (ASA) scores of Ⅰ or Ⅱ, scheduled for open pulmonary lobectomy under propofol - remifentanil total intravenous anaesthesia, were randomly divided into 3 groups (n = 30 each) by using a random number table: PCIA group (group G), Ultrasound-guided TPVB combined with PCIA group (group U), and open TPVB combined with PCIA group (group E). In group G, patients were received PCIA after the surgery. In group U, TPVB was performed on the operated side under ultrasound guidance with 0.25% ropivacaine 30 ml combined with the PCIA after the surgery. In group E, the TPVB was performed under the direct vision with 0.25% ropivacaine 30 ml combined with the PCIA. The Visual Analogue Score (VAS) at rest and during coughing, the sensory nerve block segment, as well as the respiratory rate were measured and recorded at different time-points. Furthermore, the hemodynamic vital signs at different time - points, the number of successfully delivered doses 48 h after the surgery, as well as the incidence of postoperative complications were also recorded and analyzed.

Conditions: Lung Cancer
Being tested: Open TPVB, Ultrasound-guided TPVB, placebo
Keywords: thoracic paravertebral block, postoperative analgesia, pulmonary lobectomy
Medical subject headings: Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Open TPVBCombination product
In Group E,the thoracic paravertebral block was performed under the direct vision with 0.25% ropivacaine 30 ml,and the Patient-controlled intravenous analgesia was administer after the surgery.
Ultrasound-guided TPVBCombination product
In Group U, thoracic paravertebral block was performed on the operated side under ultrasound guidance with 0.25% ropivacaine 30 ml,and the Patient-controlled intravenous analgesia was administer after the surgery.
placeboOther
In Group G,patients were just received Patient-controlled intravenous analgesia after the surgery.

Study groups in NCT03449563
Study group	Role	What they receive
Placebo group (group G)	Placebo comparator	Not described Receives: Other: placebo
Ultrasound-guided TPVB group (group U)	Active comparator	Not described Receives: Combination Product: Ultrasound-guided TPVB
open TPVB group(group E)	Experimental	Not described Receives: Combination Product: Open TPVB

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Visual Analogue Score at rest
Visual Analogue Score at rest was recorded at 30 minutes after extubation,1 hour after extubation, 2 hour after extubation, 4 hour after extubation, 6 hour after extubation, 8 hour after extubation, 12 hour after extubation, 24 hour after extubation, 48 hour after extubation. And the Visual Analogue Score was ranged from 0 to 10 (0 = no pain and 10 = worst pain imaginable).
Measured: 30 minutes after extubation,1 hour after extubation, 2 hour after extubation, 4 hour after extubation, 6 hour after extubation, 8 hour after extubation, 12 hour after extubation, 24 hour after extubation, 48 hour after extubation
Change in Visual Analogue Score during coughing
Visual Analogue Score (VAS) during coughing was recorded 30 minutes after extubation,1 hour after extubation, 2 hour after extubation, 4 hour after extubation, 6 hour after extubation, 8 hour after extubation, 12 hour after extubation, 24 hour after extubation, 48 hour after extubation. And the Visual Analogue Score was ranged from 0 to 10 (0 = no pain and 10 = worst pain imaginable).
Measured: 30 minutes after extubation,1 hour after extubation, 2 hour after extubation, 4 hour after extubation, 6 hour after extubation, 8 hour after extubation, 12 hour after extubation, 24 hour after extubation, 48 hour after extubation
Change in the respiratory rate
The respiratory rate was recorded at 30 minutes after extubation,1 hour after extubation, 2 hour after extubation, 4 hour after extubation, 6 hour after extubation, 8 hour after extubation, 12 hour after extubation, 24 hour after extubation, 48 hour after extubation.
Measured: 30 minutes after extubation,1 hour after extubation, 2 hour after extubation, 4 hour after extubation, 6 hour after extubation, 8 hour after extubation, 12 hour after extubation, 24 hour after extubation, 48 hour after extubation.

Secondary outcomes (7)

Change in Blood pressure
The blood pressure was recorded at the time points of immediately after the nerve block, 5 minutes after the nerve block, 10 minutes after the nerve block, 15 minutes after the nerve block, 20 minutes after the nerve block, 30 minutes after the nerve block, 45 minutes after the nerve block, 1 hour after the nerve block, 2 hour after the nerve block.
Measured: immediately after the nerve block, 5 minutes after the nerve block, 10 minutes after the nerve block, 15 minutes after the nerve block, 20 minutes after the nerve block, 30 minutes after the nerve block, 45 minutes after the nerve block, 1 hour after the
Change in Heart Rate
The Heart Rate was recorded at the time points of immediately after the nerve block, 5 minutes after the nerve block, 10 minutes after the nerve block, 15 minutes after the nerve block, 20 minutes after the nerve block, 30 minutes after the nerve block, 45 minutes after the nerve block, 1 hour after the nerve block, 2 hour after the nerve block.
Measured: immediately after the nerve block, 5 minutes after the nerve block, 10 minutes after the nerve block, 15 minutes after the nerve block, 20 minutes after the nerve block, 30 minutes after the nerve block, 45 minutes after the nerve block, 1 hour after the
Change in pulse oximetry
The pulse oximetry was recorded at the time points of immediately after the nerve block, 5 minutes after the nerve block, 10 minutes after the nerve block, 15 minutes after the nerve block, 20 minutes after the nerve block, 30 minutes after the nerve block, 45 minutes after the nerve block, 1 hour after the nerve block, 2 hour after the nerve block.
Measured: immediately after the nerve block, 5 minutes after the nerve block, 10 minutes after the nerve block, 15 minutes after the nerve block, 20 minutes after the nerve block, 30 minutes after the nerve block, 45 minutes after the nerve block, 1 hour after the
The number of successfully delivered doses of the patient-controlled intravenous analgesia pump
The number of successfully delivered doses of the patient-controlled intravenous analgesia pump was recorded 48 hour after the surgery.
Measured: 48 hour after the surgery
The operating time of thoracic paravertebral block
Measured: From onset the thoracic paravertebral block to 24 hour after the surgery
The degree of parents'satisfaction with analgesia
The degree of parents'satisfaction with analgesia was recorded three days after the surgery.
Measured: up to three days after the surgery
The postoperative complications like agitation, respiratory depression, nausea, vomiting
The postoperative complications like agitation, respiratory depression, nausea, vomiting were recorded three days after the surgery.
Measured: up to three days after the surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 201628 Dec 2017

First posted28 Feb 2018
Study start1 Sep 2016
Primary completion9 Nov 2017
Study completion28 Dec 2017

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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03449563
Sponsor's protocol ID: Nerve block
Status last verified: Feb 2018
First submitted: 11 Feb 2018
Last updated: 28 Feb 2018
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Open Thoracic Paravertebral Block on Postoperative Analgesia in Patients Undergoing Open Pulmonary Lobectomy
ClinicalTrials.gov ID: NCT03449563
Acronym / sponsor ID: Nerve block
Conditions: Lung Cancer
Keywords: thoracic paravertebral block, postoperative analgesia, pulmonary lobectomy
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Kunming Medical UniversityUniversity, hospital or other
Study start: 1 Sep 2016 (actual)
Primary completion: 9 Nov 2017 (actual)
Study completion: 28 Dec 2017 (actual)
First posted: 28 Feb 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.

Detailed description

Purpose: The study was aimed to assess the effects of open thoracic paravertebral block on postoperative analgesia in patients undergoing open pulmonary lobectomy under general anesthesia.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
Placebo group (group G)	Placebo comparator	Other: placebo
Ultrasound-guided TPVB group (group U)	Active comparator	Combination Product: Ultrasound-guided TPVB
open TPVB group(group E)	Experimental	Combination Product: Open TPVB

Who may qualify

Ages: 35 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

with American Society of Anesthesiologists physical status Ⅰor Ⅱ
aged 35 - 75 years old
with body mass index of 20 - 25 kg／m2,
scheduled for open pulmonary lobectomy under general anaesthesia at the First Affiliated Hospital of Kunming Medical University

Key exclusion criteria (4 listed)

cardiovascular and/or cerebrovascular disease;
diabetes; pre-existing liver, lung or kidney dysfunction;
bilateral surgery; take operations again within 48 h after the surgery;
with serious pulmonary infection and coagulation dysfunction

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
Open TPVBIn Group E,the thoracic paravertebral block was performed under the direct vision with 0.25% ropivacaine 30 ml,and the Patient-controlled intravenous analgesia was administer after the surgery.	Combination product	open TPVB group(group E)
Ultrasound-guided TPVBIn Group U, thoracic paravertebral block was performed on the operated side under ultrasound guidance with 0.25% ropivacaine 30 ml,and the Patient-controlled intravenous analgesia was administer after the surgery.	Combination product	Ultrasound-guided TPVB group (group U)
placeboIn Group G,patients were just received Patient-controlled intravenous analgesia after the surgery.	Other	Placebo group (group G)

Primary outcome

Change in Visual Analogue Score at rest
Time frame: 30 minutes after extubation,1 hour after extubation, 2 hour after extubation, 4 hour after extubation, 6 hour after extubation, 8 hour after extubation, 12 hour after extubation, 24 hour after extubation, 48 hour after extubation
Visual Analogue Score at rest was recorded at 30 minutes after extubation,1 hour after extubation, 2 hour after extubation, 4 hour after extubation, 6 hour after extubation, 8 hour after extubation, 12 hour after extubation, 24 hour after extubation, 48 hour after extubation. And the Visual Analogue Score was ranged from 0 to 10 (0 = no pain and 10 = worst pain imaginable).
Change in Visual Analogue Score during coughing
Time frame: 30 minutes after extubation,1 hour after extubation, 2 hour after extubation, 4 hour after extubation, 6 hour after extubation, 8 hour after extubation, 12 hour after extubation, 24 hour after extubation, 48 hour after extubation
Visual Analogue Score (VAS) during coughing was recorded 30 minutes after extubation,1 hour after extubation, 2 hour after extubation, 4 hour after extubation, 6 hour after extubation, 8 hour after extubation, 12 hour after extubation, 24 hour after extubation, 48 hour after extubation. And the Visual Analogue Score was ranged from 0 to 10 (0 = no pain and 10 = worst pain imaginable).
Change in the respiratory rate
Time frame: 30 minutes after extubation,1 hour after extubation, 2 hour after extubation, 4 hour after extubation, 6 hour after extubation, 8 hour after extubation, 12 hour after extubation, 24 hour after extubation, 48 hour after extubation.
The respiratory rate was recorded at 30 minutes after extubation,1 hour after extubation, 2 hour after extubation, 4 hour after extubation, 6 hour after extubation, 8 hour after extubation, 12 hour after extubation, 24 hour after extubation, 48 hour after extubation.

7 secondary outcomes

Change in Blood pressure
Time frame: immediately after the nerve block, 5 minutes after the nerve block, 10 minutes after the nerve block, 15 minutes after the nerve block, 20 minutes after the nerve block, 30 minutes after the nerve block, 45 minutes after the nerve block, 1 hour after the
Change in Heart Rate
Time frame: immediately after the nerve block, 5 minutes after the nerve block, 10 minutes after the nerve block, 15 minutes after the nerve block, 20 minutes after the nerve block, 30 minutes after the nerve block, 45 minutes after the nerve block, 1 hour after the
Change in pulse oximetry
Time frame: immediately after the nerve block, 5 minutes after the nerve block, 10 minutes after the nerve block, 15 minutes after the nerve block, 20 minutes after the nerve block, 30 minutes after the nerve block, 45 minutes after the nerve block, 1 hour after the
The number of successfully delivered doses of the patient-controlled intravenous analgesia pump
Time frame: 48 hour after the surgery
The operating time of thoracic paravertebral block
Time frame: From onset the thoracic paravertebral block to 24 hour after the surgery
The degree of parents'satisfaction with analgesia
Time frame: up to three days after the surgery
The postoperative complications like agitation, respiratory depression, nausea, vomiting
Time frame: up to three days after the 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 28 Feb 2018.

Related trials for Lung Cancer

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer

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.

Guoliang Zhao principal investigator

First Affiliated Hospital of Kunming Medical University

Questions about this trial

What is this clinical trial studying?

A study testing Open TPVB and Ultrasound-guided TPVB in people with Lung Cancer, run by Kunming Medical University.

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 4 inclusion and 4 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 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

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.

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 in Visual Analogue Score at rest (time frame: 30 minutes after extubation,1 hour after extubation, 2 hour after extubation, 4 hour after extubation, 6 hour after extubation, 8 hour after extubation, 12 hour after extubation, 24 hour after extubation, 48 hour after extubation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03449563.

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 28 Feb 2018.