Pain, PostoperativeNCT03242668
Paravertebral Block for Postoperative Analgesia in Thoracoscopic Surgery
A study testing VATS, PVB using PVC and PCA in people with Pain, Postoperative, run by Nguyen Trung Kien at 1 site in Vietnam.
Trial summary
To access the analgesic efficacy of patient controlled thoracic paravertebral analgesia. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- VATS, PVB using PVC and PCA
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Jun 2016to 1 Jul 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists class I to III risk undergoing elective VATS, aged 32-72 years, scheduled for lung resection surgery.
Who cannot join
- Patients who refused to participate, less than 18 years of age, ASA physical status 3 or more,, allergy to any of the study drugs, patients having any contraindication to placement of PVB, kyphoscoliosis, presence of acute herpes zoster, chronic pain syndrome, chronic analgesic use and psychiatric disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Controlled Paravertebral Analgesia for Video-assisted Thoracoscopic Surgery
To access the analgesic efficacy of patient controlled thoracic paravertebral analgesia.
Read the detailed description
The study was carried out on thirty patients who underwent video-assisted thoracic surgery.Paravertebral space was identified by loss of resistance technique under video-assisted inside thoracic space before chest close.Initiated dose of 0.3ml/kg of bupivacaine 0.125%+fentanyl 2 mcg/ml was administered then continued patient-controlled analgesia with background rate 3ml/h, bolus dose 2ml, lockout interval 10 minutes. Postoperative pain was accessed by Visual Analogue Scale at rest and on coughing; monitor the heart rate, blood pressure, respiratory rate, SpO2, arterial blood gas and spirometry in three postoperative consecutive days.
- Conditions
- Pain, Postoperative
- Being tested
- VATS, PVB using PVC, PCA
- Keywords
- paravertebral block,PVC,PCA
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VATSProcedure or surgery
Also called Video-Assisted Thoracic Surgery
General anesthesia was induced with 2.0 mg/kg of propofol, 2.0 mg/kg of fentanyl, and 1.0 mg kg/1 of rocuronium and maintained with continuous infusion 6-12mg/kg/h of propofol,injected 2.0 mg/kg of fentanyl and 0.15 mg/ kg of rocuronium every 30 minutes . All patients were intubated with a double-lumen endobronchial tube for one-lung ventilation.The VATS (Video-Assisted Thoracic Surgery) was performed.
PVB using PVCProcedure or surgery
Also called Paravertebral block using paravertebral catheter
At the end of the surgery, the upper edge of the spinous process of the thoracic vertebral body was recognized. With an epidural needle (Tuohy 22 G; Braun, Melsungen, Germany), the injection point was punctured 2 cm lateral to the midline. The paravertebral space was entered by advancing the Tuohy needle over the superior border of the transverse process. Once in the right place, the PVC was placed through the needle, checking the tip remained placed when removing the needle. The advance of the needle and the entering of the catheter into the paravertebral space were verified all the time by the surgeon using the camera. The PVC (Paravertebral Catheter ) was inserted at this point preversed at this area.
PCADrug
Also called Patient controlled analgesia
PVC was inserted.Initiated dose of 0.3ml/kg of Bupivacaine Hydrochloride 1.25mg/ml and Fentanyl Citrate 2 micrograms/ml was administered then continued PCA (Perfusor space pump,Germany)with background rate 3ml/h, bolus dose 2ml was infused through PVC.
| Study group | Role | What they receive |
|---|---|---|
| PVB using PVC for PCA in VATS | Experimental | The VATS was performed.Paravertebral space was identified by loss of resistance technique combined with video-assisted inside thoracic space before chest close.PVC was inserted.Initiated dose of 0.3ml/kg of Bupivacaine Hydrochloride 1.25mg/ml and Fentanyl Citrate 2 micrograms/ml was administered then continued PCA with background rate 3ml/h, bolus dose 2ml was infused through PVC. Receives: Procedure: VATS; Procedure: PVB using PVC; Drug: PCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS score at rest and on coughing
Using VAS scale (Atrazennica)
Measured: 72 hours
Secondary outcomes (5)
Analgesia effects on respiratory function
Using Spirometry (Chestgraph H1 - 105,Japane) to evaluate respiratory index
Measured: three postoperative consecutive days
Arterial blood gas values
Using Arterial blood gas analysis (STAT Model No.MCP9819-065, Martel Instruments Ltd)
Measured: three postoperative consecutive days
The number dermatome inhibition
Using pin-prick test
Measured: three postoperative consecutive days
Rescue analgesia
When VAS score equal to or more than 4 using fentanyl to manage pain
Measured: three postoperative consecutive days
Patient's satisfaction
Using questionaire with 4 levels :not good,satisfied,good,very good
Measured: three postoperative consecutive days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2017
- Study start1 Jun 2016
- Primary completion1 Jun 2017
- Study completion1 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- 30 patients, with American Society of Anesthesiologists class I to III risk undergoing elective VATS, aged 32-72 years, scheduled for lung resection surgery , were enrolled in this randomised observer blinded prospective clinical study. Patients who refused to participate, less than 18 years of age, ASA physical status 3 or more, allergy to any of the study drugs, patients having any contraindication for paravertebral block, kyphoscoliosis, presence of acute herpes zoster, chronic pain syndrome, chronic analgesic use and psychiatric disease were excluded from this study.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nguyen Trung Kien
- Sponsor type
- University, hospital or other
- Collaborators
- Nguyen Truong Giang, PhD. Associate Prof.
- Responsible party
- Sponsor-investigator, Nguyen Trung Kien, Vietnam Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03242668
- Sponsor's protocol ID
- 103HospitalVMMU
- Status last verified
- Aug 2017
- First submitted
- 25 Jul 2017
- Last updated
- 8 Aug 2017
- 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 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Controlled Paravertebral Analgesia for Video-assisted Thoracoscopic Surgery
- ClinicalTrials.gov ID
- NCT03242668
- Acronym / sponsor ID
- 103HospitalVMMU
- Conditions
- Pain, Postoperative
- Keywords
- paravertebral block,PVC,PCA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Nguyen Trung KienUniversity, hospital or other
- Collaborators
- Nguyen Truong Giang, PhD. Associate Prof.
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 8 Aug 2017 (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.
To access the analgesic efficacy of patient controlled thoracic paravertebral analgesia.
Detailed description
The study was carried out on thirty patients who underwent video-assisted thoracic surgery.Paravertebral space was identified by loss of resistance technique under video-assisted inside thoracic space before chest close.Initiated dose of 0.3ml/kg of bupivacaine 0.125%+fentanyl 2 mcg/ml was administered then continued patient-controlled analgesia with background rate 3ml/h, bolus dose 2ml, lockout interval 10 minutes. Postoperative pain was accessed by Visual Analogue Scale at rest and on coughing; monitor the heart rate, blood pressure, respiratory rate, SpO2, arterial blood gas and spirometry in three postoperative consecutive days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 30 patients, with American Society of Anesthesiologists class I to III risk undergoing elective VATS, aged 32-72 years, scheduled for lung resection surgery , were enrolled in this randomised observer blinded prospective clinical study. Patients who refused to participate, less than 18 years of age, ASA physical status 3 or more, allergy to any of the study drugs, patients having any contraindication for paravertebral block, kyphoscoliosis, presence of acute herpes zoster, chronic pain syndrome, chronic analgesic use and psychiatric disease were excluded from this study.
| Arm | Type | Receives |
|---|---|---|
| PVB using PVC for PCA in VATS | Experimental | Procedure: VATS, Procedure: PVB using PVC, Drug: PCAThe VATS was performed.Paravertebral space was identified by loss of resistance technique combined with video-assisted inside thoracic space before chest close.PVC was inserted.Initiated dose of 0.3ml/kg of Bupivacaine Hydrochloride 1.25mg/ml and Fentanyl Citrate 2 micrograms/ml was administered then continued PCA with background rate 3ml/h, bolus dose 2ml was infused through PVC. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists class I to III risk undergoing elective VATS, aged 32-72 years, scheduled for lung resection surgery.
Key exclusion criteria (1 listed)
- Patients who refused to participate, less than 18 years of age, ASA physical status 3 or more,, allergy to any of the study drugs, patients having any contraindication to placement of PVB, kyphoscoliosis, presence of acute herpes zoster, chronic pain syndrome, chronic analgesic use and psychiatric 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 |
|---|---|---|
| VATSAlso: Video-Assisted Thoracic SurgeryGeneral anesthesia was induced with 2.0 mg/kg of propofol, 2.0 mg/kg of fentanyl, and 1.0 mg kg/1 of rocuronium and maintained with continuous infusion 6-12mg/kg/h of propofol,injected 2.0 mg/kg of fentanyl and 0.15 mg/ kg of rocuronium every 30 minutes . All patients were intubated with a double-lumen endobronchial tube for one-lung ventilation.The VATS (Video-Assisted Thoracic Surgery) was performed. | Procedure or surgery | PVB using PVC for PCA in VATS |
| PVB using PVCAlso: Paravertebral block using paravertebral catheterAt the end of the surgery, the upper edge of the spinous process of the thoracic vertebral body was recognized. With an epidural needle (Tuohy 22 G; Braun, Melsungen, Germany), the injection point was punctured 2 cm lateral to the midline. The paravertebral space was entered by advancing the Tuohy needle over the superior border of the transverse process. Once in the right place, the PVC was placed through the needle, checking the tip remained placed when removing the needle. The advance of the needle and the entering of the catheter into the paravertebral space were verified all the time by the surgeon using the camera. The PVC (Paravertebral Catheter ) was inserted at this point preversed at this area. | Procedure or surgery | PVB using PVC for PCA in VATS |
| PCAAlso: Patient controlled analgesiaPVC was inserted.Initiated dose of 0.3ml/kg of Bupivacaine Hydrochloride 1.25mg/ml and Fentanyl Citrate 2 micrograms/ml was administered then continued PCA (Perfusor space pump,Germany)with background rate 3ml/h, bolus dose 2ml was infused through PVC. | Drug | PVB using PVC for PCA in VATS |
Primary outcome
VAS score at rest and on coughing
Time frame: 72 hours
Using VAS scale (Atrazennica)
5 secondary outcomes
Analgesia effects on respiratory function
Time frame: three postoperative consecutive days
Arterial blood gas values
Time frame: three postoperative consecutive days
The number dermatome inhibition
Time frame: three postoperative consecutive days
Rescue analgesia
Time frame: three postoperative consecutive days
Patient's satisfaction
Time frame: three postoperative consecutive days
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 8 Aug 2017.
- 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 study testing VATS, PVB using PVC and PCA in people with Pain, Postoperative, run by Nguyen Trung Kien at 1 site in Vietnam.
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 1 inclusion and 1 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 8 Aug 2017. 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 Vietnam. 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?
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?
VAS score at rest and on coughing (time frame: 72 hours). 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 8 Aug 2017.