Lung CancerNCT04025606
Paravertebral Block Versus Thoracic Epidural Analgesia
A study testing Thoracic epidural and Paravertebral block in people with Lung Cancer and Postoperative Pain, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
Thoracic epidural analgesia (TEA) is the basic method of analgesia in patients undergoing pulmonary lobectomy. TEA is considered to be a safe and thoroughly investigated method of pain relief that rarely causes serious complications. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lung Cancer, Postoperative Pain
- What is being tested?
- Thoracic epidural and Paravertebral block
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteNorway
- Study dates
- 24 Jun 2019to 1 Dec 2022
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with lung cancer in stage 1 or 2 who are accepted for VATS-lobectomy
Who cannot join
- Patients who do not wish to participate
- Patients with:
- suspicion of ingrowth in the thoracic wall.
- marginal lung function.
- kidney failure.
- chronic pains and/ or daily use of opioids.
Show all 14Show fewer
- cognitive, visual and / or linguistic dysfunction.
- allergies to drugs used in the paravertebral block or the thoracic epidural analgesia.
- conversion from VATS to thoractomy.
- unsuccessful admission of thoracic epidural analgesia
- unsuccessful admission of paravertebral block
- postoperative respiratory treatment
- postoperative delirium Patients who for various reasons are not able to self-report pain after surgery.
- Patients who wish to withdraw from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Paravertebral Block Versus Thoracic Epidural Analgesia in Patients Undergoing Video Assisted Lung Surgery
Thoracic epidural analgesia (TEA) is the basic method of analgesia in patients undergoing pulmonary lobectomy. TEA is considered to be a safe and thoroughly investigated method of pain relief that rarely causes serious complications. However, blocking the nerves as they emerge from the spinal column (paravertebral block, PVB) may represent an alternative method with some potential benefits. In this study, TEA and PVB will be compared for patients undergoing pulmonary lobectomy by video assisted thoracoscopic surgery. The aim of the study is to test the hypothesis, that PVB is a time-saving procedure compared with TEA on the day of surgery and that PVB is as efficient in postoperative pain reduction as TEA.
- Conditions
- Lung Cancer, Postoperative Pain
- Being tested
- Thoracic epidural, Paravertebral block
- Keywords
- Epidural analgesia, Pneumonectomy
- Medical subject headings
- Lung Neoplasms, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic epiduralDrug
Standard thoracic epidural (needle inserted into the space between the covering of spinal cord and the cord itself) preoperatively. Standard thoracic epidural analgesia mixture (2 mg/ ml bupivacaine, 2 µg/ ml fentanyl and 2 µg/ ml adrenalin) with an infusion of 6-10 ml/hour until day 2 postoperatively. Thereafter reduction by 30 % every four hours.
Paravertebral blockDrug
Paravertebral block containing 5 ml bupivacaine 5 mg/ ml (optionally 10 ml bupivacaine 2,5 mg/ ml). In addition per-oral painkillers (oxycodone and paracetamol) from the day of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Thoracic epidural analgesia | Active comparator | Standard thoracic epidurals preoperatively at the dag of surgery. Receives: Drug: Thoracic epidural |
| Paravertebral block | Experimental | Paravertebral block inserted at the end of the operation by the surgeons Receives: Drug: Paravertebral block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in minutes total time at the operating ward
Measured: 1 hour
Pain intensity during hospitalization: Numerical Rating Scale (NRS)
using the Numerical Rating Scale (NRS) in predetermined time intervals after the operation
Measured: Up to 12 months after surgery
Secondary outcomes (1)
Hospital length of stay in days
Measured: until discharge from hospital (max 1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start24 Jun 2019
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
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.
- More trials run by St. Olavs HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Wahba, md phd, Study director, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04025606
- Sponsor's protocol ID
- 2017/2424
- Status last verified
- Dec 2023
- First submitted
- 12 Jun 2019
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paravertebral Block Versus Thoracic Epidural Analgesia in Patients Undergoing Video Assisted Lung Surgery
- ClinicalTrials.gov ID
- NCT04025606
- Acronym / sponsor ID
- 2017/2424
- Conditions
- Lung Cancer, Postoperative Pain
- Keywords
- Epidural analgesia, Pneumonectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 19 Jul 2019 (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.
Thoracic epidural analgesia (TEA) is the basic method of analgesia in patients undergoing pulmonary lobectomy. TEA is considered to be a safe and thoroughly investigated method of pain relief that rarely causes serious complications. However, blocking the nerves as they emerge from the spinal column (paravertebral block, PVB) may represent an alternative method with some potential benefits. In this study, TEA and PVB will be compared for patients undergoing pulmonary lobectomy by video assisted thoracoscopic surgery. The aim of the study is to test the hypothesis, that PVB is a time-saving procedure compared with TEA on the day of surgery and that PVB is as efficient in postoperative pain reduction as TEA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracic epidural analgesia | Active comparator | Drug: Thoracic epiduralStandard thoracic epidurals preoperatively at the dag of surgery. |
| Paravertebral block | Experimental | Drug: Paravertebral blockParavertebral block inserted at the end of the operation by the surgeons |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with lung cancer in stage 1 or 2 who are accepted for VATS-lobectomy
Key exclusion criteria (14 listed)
- Patients who do not wish to participate
- suspicion of ingrowth in the thoracic wall.
- marginal lung function.
- kidney failure.
- chronic pains and/ or daily use of opioids.
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 epiduralStandard thoracic epidural (needle inserted into the space between the covering of spinal cord and the cord itself) preoperatively. Standard thoracic epidural analgesia mixture (2 mg/ ml bupivacaine, 2 µg/ ml fentanyl and 2 µg/ ml adrenalin) with an infusion of 6-10 ml/hour until day 2 postoperatively. Thereafter reduction by 30 % every four hours. | Drug | Thoracic epidural analgesia |
| Paravertebral blockParavertebral block containing 5 ml bupivacaine 5 mg/ ml (optionally 10 ml bupivacaine 2,5 mg/ ml). In addition per-oral painkillers (oxycodone and paracetamol) from the day of surgery. | Drug | Paravertebral block |
Primary outcome
Time in minutes total time at the operating ward
Time frame: 1 hour
Pain intensity during hospitalization: Numerical Rating Scale (NRS)
Time frame: Up to 12 months after surgery
using the Numerical Rating Scale (NRS) in predetermined time intervals after the operation
1 secondary outcome
Hospital length of stay in days
Time frame: until discharge from hospital (max 1 month)
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 Jan 2024.
- 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.
Alexander Wahba, md phd study director
St. Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic epidural and Paravertebral block in people with Lung Cancer and Postoperative Pain, run by St. Olavs Hospital at 1 site in Norway.
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 14 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 Jan 2024. 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 Norway. 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?
Time in minutes total time at the operating ward (time frame: 1 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 3 Jan 2024.