Pain, PostoperativePhase 4VATSNCT02302586
Thoracic Paravertebral Blockade in Video Assisted Thoracoscopic Surgery (VATS)
A Phase 4 study testing Thoracic paravertebral block (TPVB) in people with Pain, Postoperative, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Video-assisted thoracoscopic surgeries (VATS) include severe postoperative acute pain which is also a predictor of chronic pain. In this study, the investigators aim to compare the postoperative effects of thoracic paravertebral block (TPVB) and intravenous patient controlled analgesia (PCA) on the prevention of… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Thoracic paravertebral block (TPVB)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2014to Dec 2015
- 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
- ASA I-III Patients who undergo Video-assisted thoracoscopic surgery (VATS) under GA
Who cannot join
- Patients with difficult understanding the instructions for using PCA and/or pain scales Patients with contraindication to regional anesthesia Patients with significant neurologic, psychiatric or cognitive disorders History of substance abuse or chronic opioid use
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University, Department of Anesthesiology
Istanbul, 34093
About this study
Official title: Effects of Thoracic Paravertebral Blockade on Acute and Chronic Pain After Video Assisted Thoracoscopic Surgery (VATS) - A Randomized, Clinical Trial
Video-assisted thoracoscopic surgeries (VATS) include severe postoperative acute pain which is also a predictor of chronic pain. In this study, the investigators aim to compare the postoperative effects of thoracic paravertebral block (TPVB) and intravenous patient controlled analgesia (PCA) on the prevention of chronic pain of patients undergoing VATS.
Read the detailed description
Video-assisted thoracoscopic surgeries (VATS) include significant postoperative acute and chronic pain because of trocar site tissue damages, intercostal nerve injuries and related inflammatory responses. Poorly controlled pain in the early postoperative period usually causes chronic pain, and also affects patients' physiotherapy, mobilization and daily function.
Our hypothesis in this study is 'thoracic paravertebral block (TPVB) is associated with an improvement in control of acute and chronic pain after VATS compared to systemic analgesia.
- Conditions
- Pain, Postoperative
- Being tested
- Thoracic paravertebral block (TPVB), Patient Controlled Analgesia (IV PCA)
- Keywords
- Thoracic paravertebral block, Patient controlled analgesia, Video Assisted Thoracoscopic Surgery, Postoperative acute pain, Chronic pain
- Medical subject headings
- Pain, Postoperative, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic paravertebral block (TPVB)Drug
Also called Bupivacaine
Thoracic paravertebral block (TPVB) is being performed by injecting 5 mL of Bupivacaine 0.5% to 4 consecutive level of paravertebral spaces between T4 and T8 by using landmark technique
Patient Controlled Analgesia (IV PCA)Drug
Also called Morphine
IV morphine patient controlled analgesia (PCA) is being used in the postoperative period for 48 hours. Basal infusion: 0.3 mg/kg/h, Bolus: 1 mg, Lock-out time: 20 min, 4-h limit: 10-12,5 mg
| Study group | Role | What they receive |
|---|---|---|
| Patient Controlled Analgesia (IV PCA) | Active comparator | Postoperative intravenous (IV) morphine PCA is being used for acute pain control: Basal infusion: 0.3 mg/kg/h Bolus: 1 mg, Lock-out time: 20 min, 4-h limit: 10-12,5 mg Receives: Drug: Patient Controlled Analgesia (IV PCA) |
| Thoracic Paravertebral Block (TPVB) | Active comparator | Preoperative thoracic paravertebral block (TPVB) at 4 levels from T4 to T8 is being performed and total of 20 mL Bupivacaine 0.5% is deposited (5 mL per level by using landmark technique) Receives: Drug: Thoracic paravertebral block (TPVB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative chronic pain scores (VAS) at rest and during mobilization
Chronic pain follow-up
Measured: Up to 6 months
Secondary outcomes (8)
Postoperative vital signs
Postoperative early period hemodynamic follow-up
Measured: 0-48 hours
Postoperative acute pain at rest and during coughing/mobilization
Postoperative acute pain score (VAS) follow-up
Measured: 0-48 hours
Postoperative nausea and vomiting (PONV) and antiemetic requirements
Postoperative acute PONV and antiemetic use follow-up
Measured: 0-48 hours
Postoperative morphine consumption
Postoperative IV PCA morphine consumption for Group 1 and IV morphine consumption for Group 2 as rescue analgesic
Measured: 0-48 hours
Time to first analgesic
Postoperative first analgesic IV PCA morphine demand time for Group 1 and first rescue analgesic IV morphine time for Group 2
Measured: 0-48 hours
Postoperative first oral intake, flatulence, defecation, mobilization times
Postoperative first oral intake, flatulence, defecation, mobilization times
Measured: 0-48 hours
Postoperative hospital discharge day and time
Postoperative hospital discharge day and time
Measured: Participants is being followed for the duration of hospital stay, an expected average of 1 week
Postoperative long term (1st, 3rd and 6th months) analgesic, sleep quality and comfort follow-up
Postoperative long term (1st, 3rd and 6th months) analgesic, sleep quality and comfort follow-up with phone call
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuzhet Mert Senturk, MD, Prof, Istanbul University
- Investigators
- Mert N Senturk, Prof, Principal investigator, MD, Prof
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02302586
- Sponsor's protocol ID
- 46143867-1035
- Acronym
- VATS
- Status last verified
- Aug 2017
- First submitted
- 20 Nov 2014
- Last updated
- 3 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Komatsu T, Kino A, Inoue M, Sowa T, Takahashi K, Fujinaga T. Paravertebral block for video-assisted thoracoscopic surgery: analgesic effectiveness and role in fast-track surgery. Int J Surg. 2014;12(9):936-9. doi: 10.1016/j.ijsu.2014.07.272. Epub 2014 Aug 1.
PubMed 25091399
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Thoracic Paravertebral Blockade on Acute and Chronic Pain After Video Assisted Thoracoscopic Surgery (VATS) - A Randomized, Clinical Trial
- ClinicalTrials.gov ID
- NCT02302586
- Acronym / sponsor ID
- VATS / 46143867-1035
- Conditions
- Pain, Postoperative
- Keywords
- Thoracic paravertebral block, Patient controlled analgesia, Video Assisted Thoracoscopic Surgery, Postoperative acute pain, Chronic pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 27 Nov 2014 (estimated)
- 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.
Video-assisted thoracoscopic surgeries (VATS) include severe postoperative acute pain which is also a predictor of chronic pain. In this study, the investigators aim to compare the postoperative effects of thoracic paravertebral block (TPVB) and intravenous patient controlled analgesia (PCA) on the prevention of chronic pain of patients undergoing VATS.
Detailed description
Video-assisted thoracoscopic surgeries (VATS) include significant postoperative acute and chronic pain because of trocar site tissue damages, intercostal nerve injuries and related inflammatory responses. Poorly controlled pain in the early postoperative period usually causes chronic pain, and also affects patients' physiotherapy, mobilization and daily function.
Our hypothesis in this study is 'thoracic paravertebral block (TPVB) is associated with an improvement in control of acute and chronic pain after VATS compared to systemic analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Controlled Analgesia (IV PCA) | Active comparator | Drug: Patient Controlled Analgesia (IV PCA)Postoperative intravenous (IV) morphine PCA is being used for acute pain control: Basal infusion: 0.3 mg/kg/h Bolus: 1 mg, Lock-out time: 20 min, 4-h limit: 10-12,5 mg |
| Thoracic Paravertebral Block (TPVB) | Active comparator | Drug: Thoracic paravertebral block (TPVB)Preoperative thoracic paravertebral block (TPVB) at 4 levels from T4 to T8 is being performed and total of 20 mL Bupivacaine 0.5% is deposited (5 mL per level by using landmark technique) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA I-III Patients who undergo Video-assisted thoracoscopic surgery (VATS) under GA
Key exclusion criteria (1 listed)
- Patients with difficult understanding the instructions for using PCA and/or pain scales Patients with contraindication to regional anesthesia Patients with significant neurologic, psychiatric or cognitive disorders History of substance abuse or chronic opioid use
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 |
|---|---|---|
| Thoracic paravertebral block (TPVB)Also: BupivacaineThoracic paravertebral block (TPVB) is being performed by injecting 5 mL of Bupivacaine 0.5% to 4 consecutive level of paravertebral spaces between T4 and T8 by using landmark technique | Drug | Thoracic Paravertebral Block (TPVB) |
| Patient Controlled Analgesia (IV PCA)Also: MorphineIV morphine patient controlled analgesia (PCA) is being used in the postoperative period for 48 hours. Basal infusion: 0.3 mg/kg/h, Bolus: 1 mg, Lock-out time: 20 min, 4-h limit: 10-12,5 mg | Drug | Patient Controlled Analgesia (IV PCA) |
Primary outcome
Postoperative chronic pain scores (VAS) at rest and during mobilization
Time frame: Up to 6 months
Chronic pain follow-up
8 secondary outcomes
Postoperative vital signs
Time frame: 0-48 hours
Postoperative acute pain at rest and during coughing/mobilization
Time frame: 0-48 hours
Postoperative nausea and vomiting (PONV) and antiemetic requirements
Time frame: 0-48 hours
Postoperative morphine consumption
Time frame: 0-48 hours
Time to first analgesic
Time frame: 0-48 hours
Postoperative first oral intake, flatulence, defecation, mobilization times
Time frame: 0-48 hours
Postoperative hospital discharge day and time
Time frame: Participants is being followed for the duration of hospital stay, an expected average of 1 week
Postoperative long term (1st, 3rd and 6th months) analgesic, sleep quality and comfort follow-up
Time frame: Up to 6 months
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 3 Aug 2017.
- Background: PubMed 25091399Komatsu T, Kino A, Inoue M, Sowa T, Takahashi K, Fujinaga T. Paravertebral block for video-assisted thoracoscopic surgery: analgesic effectiveness and role in fast-track surgery. Int J Surg. 2014;12(9):936-9. doi: 10.1016/j.ijsu.2014.07.272. Epub 2014 Aug 1.
- Individual participant dataSharing planned: No
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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.
Mert N Senturk, Prof principal investigator
MD, Prof
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 Thoracic paravertebral block (TPVB) in people with Pain, Postoperative, run by Istanbul University at 1 site in Turkey (Türkiye).
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 3 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 Turkey (Türkiye). 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.
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?
Postoperative chronic pain scores (VAS) at rest and during mobilization (time frame: Up to 6 months). 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 NCT02302586, which also lists 1 linked publication.
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 3 Aug 2017.