Peripheral Solitary Pulmonary Nodule or TuberculomaNCT03086213
Comparative Study of Nonintubated Uniport Thoracoscopic Surgery Using Thoracic Paravertebral Nerve Block Versus Intercostal Nerve Block for Peripheral Solitary Pulmonary Nodule Patients
A study testing Propofol, Sulfentanyl and Dexmedetomidine in people with Peripheral Solitary Pulmonary Nodule or Tuberculoma, run by Shenzhen Third People's Hospital at 1 site in China.
Trial summary
The aim of this study is to study the safety and effectiveness of the effects on the perioperative pain control comparing between the thoracic paravertebral nerve block using the camera guided and the intrathoracic intercostals nerve block for the management of nonintubated local regional analgesia in uniport… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Peripheral Solitary Pulmonary Nodule or Tuberculoma
- What is being tested?
- Propofol, Sulfentanyl and Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2017to 5 Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- written informed consent
- the undetermined peripheral solitary pulmonary nodule or tuberculoma was enrolled
- the well cardiopulmonary function
- age between 18 and 65 years old
- less airway secretion
- body mass index less than 25
- I to II grade of the American Society of Anesthesiologists
- no metabolic diseases
Who cannot join
- refusal or inability to comply with the informed consent
- the nodule of the nature of the non small cell lung caner is excluded
- hypovolemia, blood disorders or abnormal clotting mechanism
- the abnormal cardiopulmonary function(the American Society of Anesthesiologists greater than 3)
- lower airway infection,more than airway secretion
- abnormal anatomy of the spine,the history of thoracic back surgery
Show all 13Show fewer
- impaired lung function(forced expiratory volume in second 1 less than predicted), or asthma uncontrolled on medications
- constrained cardiac output such as hypertrophic cardiomyopathy, mitral stenosis or complete atrioventricular block
- extensive pleural adhesion
- overweight (body mass index no less than 25)
- difficulty airway
- chronic pain score more than 5 before the surgery
- the history of bilateral thoracotomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: the Safety and Effectiveness of the Effects on the Perioperative Pain Control Comparing Between the Thoracic Paravertebral Nerve Block Using the Camera Guided and the Intrathoracic Intercostals Nerve Block for the Management of Nonintubated Local Regional Analgesia in Uniport Thoracoscopic Surgery for the Undetermined Solitary Nodules Patients
The aim of this study is to study the safety and effectiveness of the effects on the perioperative pain control comparing between the thoracic paravertebral nerve block using the camera guided and the intrathoracic intercostals nerve block for the management of nonintubated local regional analgesia in uniport thoracoscopic surgery for the undetermined solitary nodules patients.
Read the detailed description
Thoracoscopic minor lung resection has been the reasonable option for the diagnosis and treatment of management of the undetermined peripheral pulmonary nodules. Uniport procedure could reduce postoperative pain score, the length of hospital stay, moreover, nonintubated technique can avoid the disadvantages of conventional general anesthesia such as ventilator induced lung injury, sore throat or voice change. The nonintubated technique without tracheal intubation under spontaneous ventilation combined with uniport or single port thoracoscopic surgery has emerged as the least invasive procedure of wedge resection of peripheral pulmonary nodules, even the anatomical thoracoscopic lobectomy along with mediastinal lymph nodule dissection in case of the diagnosis of the primary lung cancer during the operation.
The initial experience of nonintubated thoracoscopic surgery included the intravenous controlled sedation and pain , thoracic epidural analgesia and thoracic vagus nerve block, due to series of adverse events of the epidural analgesia, operator was willing to perform the intrathoracic intercostal nerve block guided by camera during the operation and was considered as the simple and safety method for regional analgesia .However, the intercostal nerve block can not employ the adequate pain control ,after the surgery, the patient controlled analgesia is as usual needed.
The previous study showed that paravertebral block was the same effect on relieved pain as thoracic epidural analgesia and had the less complications such as hypotension, nausea or vomiting. With the advance in the technique of application of ultrasound, it is more interesting that using the ultrasound technique before the surgery is performed for the adequate pain control of the local regional analgesia in nonintubated surgery under spontaneous ventilation. However, ultrasound technique is difficult to have the skilled experience for the most anaesthetists and increase the related puncture complications such as hematoma, bleeding or pneumothorax. The method used study is guided by camera which is very simple and safety by avoidance of the puncture of the partial pleura or intercostal blood vessel, The investigators once used this approach for postoperative pain control under general intubation for lung cancer patients, so the investigators have had a skilled experience for achieving regional analgesia of nonintubated uniport thoracoscopic wedge resection.
So far, there has been no articles about thoracic paravertebral nerve block for regional analgesia of nonintubated thoracoscopic procedure patients. The investigators designed the study to compare the short term outcome on thoracic paravertebral nerve block in nonintubated technique with those of intercostal nerve block in uniport nonintubated video-assisted thoracoscopic surgery(VATS) as the control group.
This study will be performed at the third people's hospital of Shenzhen. A total of 48 patients will be enrolled(24 patients in each arms).
- Being tested
- Propofol, Sulfentanyl, Dexmedetomidine, Lidocaine, Ropivacaine
- Keywords
- nonintubated uniport thoracoscopic surgery, paravertebral nerve block, intercostal nerve block, peripheral solitary pulmonary nodule
- Medical subject headings
- Tuberculoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
anaesthetic
SulfentanylDrug
anaesthetic
DexmedetomidineDrug
anaesthetic
LidocaineDrug
local anaesthetics
RopivacaineDrug
local anaesthetics
| Study group | Role | What they receive |
|---|---|---|
| paravertebral nerve block group | Experimental | non-intubated thoracic paravertebral nerve block of regional anesthesia Thoracic paravertebral nerve block of regional anesthesia at the T4 thoracic interspace Receives: Drug: Propofol; Drug: Sulfentanyl; Drug: Dexmedetomidine; Drug: Lidocaine; Drug: Ropivacaine |
| intercostals nerve block group | Active comparator | non-intubated intercostal nerve block of regional anesthesia Thoracic intercostal nerve block of regional anesthesia at the T3/4/5 thoracic interspace Receives: Drug: Propofol; Drug: Sulfentanyl; Drug: Dexmedetomidine; Drug: Lidocaine; Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing the Inflammatory Markers During the Operation After the Intervention of the Each Group
serum concentrations of Interleukin-6
Measured: During the operation, an average of one hour
Concentration of Cortisol at Different Point During the Operation
Measured: During the operation, an average of one hour
Secondary outcomes (4)
Comparing the Hemodynamics of the Intervention of the Each Group During the Operation
data of mean arterial pressure
Measured: During the operation, an average of one hour
Comparing the Hemodynamics of the Intervention of the Each Group During the Operation
data of heart rate
Measured: During the operation, an average of one hour
Comparing the Blood Gas Analysis After the Intervention of the Each Group
data of arterial partial pressure of oxygen(PaO2) and PaCO2 at different point during the operation
Measured: During the operation, an average of one hour
Number of Participants With Puncture Related Complications
puncture related complications
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start1 Mar 2017
- Primary completion1 Sep 2019
- Study completion5 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Solitary Pulmonary Nodule or TuberculomaStudies 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
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen Third People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, xia zhaohua, Shenzhen Third People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03086213
- Sponsor's protocol ID
- 19800911
- Status last verified
- Apr 2020
- First submitted
- 7 Mar 2017
- Last updated
- 7 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: there is not a plan to make individual participant data available to other researcher.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Safety and Effectiveness of the Effects on the Perioperative Pain Control Comparing Between the Thoracic Paravertebral Nerve Block Using the Camera Guided and the Intrathoracic Intercostals Nerve Block for the Management of Nonintubated Local Regional Analgesia in Uniport Thoracoscopic Surgery for the Undetermined Solitary Nodules Patients
- ClinicalTrials.gov ID
- NCT03086213
- Acronym / sponsor ID
- 19800911
- Keywords
- nonintubated uniport thoracoscopic surgery, paravertebral nerve block, intercostal nerve block, peripheral solitary pulmonary nodule
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Shenzhen Third People's HospitalUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 5 Sep 2019 (actual)
- First posted
- 22 Mar 2017 (actual)
- Results
- Posted 7 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to study the safety and effectiveness of the effects on the perioperative pain control comparing between the thoracic paravertebral nerve block using the camera guided and the intrathoracic intercostals nerve block for the management of nonintubated local regional analgesia in uniport thoracoscopic surgery for the undetermined solitary nodules patients.
Detailed description
Thoracoscopic minor lung resection has been the reasonable option for the diagnosis and treatment of management of the undetermined peripheral pulmonary nodules. Uniport procedure could reduce postoperative pain score, the length of hospital stay, moreover, nonintubated technique can avoid the disadvantages of conventional general anesthesia such as ventilator induced lung injury, sore throat or voice change. The nonintubated technique without tracheal intubation under spontaneous ventilation combined with uniport or single port thoracoscopic surgery has emerged as the least invasive procedure of wedge resection of peripheral pulmonary nodules, even the anatomical thoracoscopic lobectomy along with mediastinal lymph nodule dissection in case of the diagnosis of the primary lung cancer during the operation.
The initial experience of nonintubated thoracoscopic surgery included the intravenous controlled sedation and pain , thoracic epidural analgesia and thoracic vagus nerve block, due to series of adverse events of the epidural analgesia, operator was willing to perform the intrathoracic intercostal nerve block guided by camera during the operation and was considered as the simple and safety method for regional analgesia .However, the intercostal nerve block can not employ the adequate pain control ,after the surgery, the patient controlled analgesia is as usual needed.
The previous study showed that paravertebral block was the same effect on relieved pain as thoracic epidural analgesia and had the less complications such as hypotension, nausea or vomiting. With the advance in the technique of application of ultrasound, it is more interesting that using the ultrasound technique before the surgery is performed for the adequate pain control of the local regional analgesia in nonintubated surgery under spontaneous ventilation. However, ultrasound technique is difficult to have the skilled experience for the most anaesthetists and increase the related puncture complications such as hematoma, bleeding or pneumothorax. The method used study is guided by camera which is very simple and safety by avoidance of the puncture of the partial pleura or intercostal blood vessel, The investigators once used this approach for postoperative pain control under general intubation for lung cancer patients, so the investigators have had a skilled experience for achieving regional analgesia of nonintubated uniport thoracoscopic wedge resection.
So far, there has been no articles about thoracic paravertebral nerve block for regional analgesia of nonintubated thoracoscopic procedure patients. The investigators designed the study to compare the short term outcome on thoracic paravertebral nerve block in nonintubated technique with those of intercostal nerve block in uniport nonintubated video-assisted thoracoscopic surgery(VATS) as the control group.
This study will be performed at the third people's hospital of Shenzhen. A total of 48 patients will be enrolled(24 patients in each arms).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| paravertebral nerve block group | Experimental | Drug: Propofol, Drug: Sulfentanyl, Drug: Dexmedetomidine, Drug: Lidocaine, Drug: Ropivacainenon-intubated thoracic paravertebral nerve block of regional anesthesia Thoracic paravertebral nerve block of regional anesthesia at the T4 thoracic interspace |
| intercostals nerve block group | Active comparator | Drug: Propofol, Drug: Sulfentanyl, Drug: Dexmedetomidine, Drug: Lidocaine, Drug: Ropivacainenon-intubated intercostal nerve block of regional anesthesia Thoracic intercostal nerve block of regional anesthesia at the T3/4/5 thoracic interspace |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- written informed consent
- the undetermined peripheral solitary pulmonary nodule or tuberculoma was enrolled
- the well cardiopulmonary function
- age between 18 and 65 years old
- less airway secretion
Key exclusion criteria (13 listed)
- refusal or inability to comply with the informed consent
- the nodule of the nature of the non small cell lung caner is excluded
- hypovolemia, blood disorders or abnormal clotting mechanism
- the abnormal cardiopulmonary function(the American Society of Anesthesiologists greater than 3)
- lower airway infection,more than airway secretion
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 |
|---|---|---|
| Propofolanaesthetic | Drug | intercostals nerve block group, paravertebral nerve block group |
| Sulfentanylanaesthetic | Drug | intercostals nerve block group, paravertebral nerve block group |
| Dexmedetomidineanaesthetic | Drug | intercostals nerve block group, paravertebral nerve block group |
| Lidocainelocal anaesthetics | Drug | intercostals nerve block group, paravertebral nerve block group |
| Ropivacainelocal anaesthetics | Drug | intercostals nerve block group, paravertebral nerve block group |
Primary outcome
Comparing the Inflammatory Markers During the Operation After the Intervention of the Each Group
Time frame: During the operation, an average of one hour
serum concentrations of Interleukin-6
Concentration of Cortisol at Different Point During the Operation
Time frame: During the operation, an average of one hour
4 secondary outcomes
Comparing the Hemodynamics of the Intervention of the Each Group During the Operation
Time frame: During the operation, an average of one hour
Comparing the Hemodynamics of the Intervention of the Each Group During the Operation
Time frame: During the operation, an average of one hour
Comparing the Blood Gas Analysis After the Intervention of the Each Group
Time frame: During the operation, an average of one hour
Number of Participants With Puncture Related Complications
Time frame: 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. there is not a plan to make individual participant data available to other researcher.
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 study testing Propofol, Sulfentanyl and Dexmedetomidine in people with Peripheral Solitary Pulmonary Nodule or Tuberculoma, run by Shenzhen Third People's Hospital 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 8 inclusion and 13 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 7 May 2020. 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. 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?
Yes. Results are posted in the registry (first posted 7 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Comparing the Inflammatory Markers During the Operation After the Intervention of the Each Group (time frame: During the operation, an average of one hour). The study lists 2 primary outcomes in all. 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 7 May 2020.