Lung TumourErLaParaNCT01621698
Study of Use of Paravertebral Blocks for Pain Relief in Video Assisted Lung Surgery
A study testing Early paravertebral block and Late Paravertebral block. in people with Lung Tumour and Lung Metastases, run by University Hospitals Bristol and Weston NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This project involves looking at the timing of providing pain relief for patients who are having lung surgery via the use of a small camera inserted into the chest with a scope (Video assisted thorascopy). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Tumour, Lung Metastases
- What is being tested?
- Early paravertebral block and Late Paravertebral block.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2012to Jul 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects will be recruited from patients admitted for elective VATS for lung resection.
- Patients aged 18 and over.
- Patient's will be ASA 1,2 or 3.
Who cannot join
- Patient refusal.
- Emergency surgery.
- Patient unable to provide consent.
- Infection in paravertebral space.
- Patients who attend a chronic pain clinic on high doses of opiate drugs.
- History of Anaphylaxis/allergy to local anaesthetic.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
United Hospitals Bristol NHS Foundation Trust
Bristol, BS2 8HW
About this study
Official title: Early Versus Late Paravertebral Block for Analgesia in Video Assisted Thoracoscopic Lung Resection.
This project involves looking at the timing of providing pain relief for patients who are having lung surgery via the use of a small camera inserted into the chest with a scope (Video assisted thorascopy). This procedure can be the source of intense pain both immediately after the procedure and in the longer term leading to chronic pain problems.
Local anaesthetic placed in the paravertebral space which is located adjacent to the spinal column, where the pain nerve fibres are located, is a well recognized method of providing pain relief for these procedures. It is currently unclear as to the best timings for providing this type of pain relief with some centres placing the local anaesthetic at the start of the procedure and some at the end. Placing a high volume of local anaesthetic into this area at the start of the case may provide better short and long term pain relief than placing it at the end of the procedure. The investigators hope to show a difference between the two timings to allow for better pain relief for these procedures. This would be a feasibility study that would lead onto a multicentre trial to eventually create a best practice protocol for pain relief for lung resection via this surgical method.
Read the detailed description
All patients will receive a general anaesthetic for their VATS procedure with full AAGBI monitoring and the WHO surgical safety checklist will be performed appropriately prior to skin incision. Induction of anaesthesia will be standardised by using propofol and the patient will be paralysed using the muscle relaxant atracurium. The amount given will be at the anaesthetist's discretion and dependent on the patient. Fentanyl at 2.5 mcg/kg will be used at induction of anaesthesia.
A double lumen endotracheal tube will be placed so lung isolation can be performed when necessary for the surgery. Anaesthesia will be maintained using a volatile agent or a target controlled infusion of propofol depending on the preference of the anaesthetist. The patient will be positioned laterally with the operative side up. All patients will receive simple intra-operative analgesia in the form of 1 gram of intravenous paracetamol and diclofenac unless the patient is over 70 or has abnormal renal function. Extra opioid analgesia will be given as intravenous morphine and this will be titrated by the anaesthetist. The amount given will be documented as part of the trial data.
Patients will be warmed to maintain a temperature between 36 and 37 degree Celsius using a warming blanket and warmed intravenous fluids. Anti-emetics in the form of ondansetron 4 mg and dexamethasone 4 mg will also be given unless there are any contraindications.
Prior to surgical incision patients in both groups will receive 1mg/kg 0.25% bupivicaine divided into 3 PV injections between the fifth and tenth thoracic vertebrae. Only trained anaesthetists with experience of over 30 PV insertions will perform the injections. The landmark technique for these injections is as follows: The spinous process of the thoracic vertebra is palpated by the anaesthetist, a 20 gauge needle is inserted 2.5 cm lateral to this and is advanced perpendicularly to the vertical and sagittal planes until the transverse process is contacted. The needle is then walked off the superior border of the transverse process, advanced a further 1 cm and one third of the weight determined local anaesthetic is delivered after careful aspiration.
Both groups will have a PV catheter placed at the start of the procedure and a bolus given straight away. As this is a double-blinded trial the anaesthetist will not know whether the bolus is local anaesthetic or saline solution.
Pharmacy at the research site will provide the 2 premade syringes that will contain either local anaesthetic or saline. The contents of the syringe will be unknown to the anaesthetist as the label will be simply numbered as 1 and 2 to be given in order as the early (1) or late (2) bolus. If it is clinically required to obtain information on what has been given a record will be immediately available from pharmacy. The syringes will be made up as neat 0.25% bupivicaine or 0.9% Normal Saline solution. The equivalent volume of 1mg/kg 0.25% bupivicaine will be injected as a bolus.
Both groups will also receive a 0.25mg/kg 0.25% bupivicaine intercostal block at closing and an infusion of 0.1% bupivicaine will then be commenced at 20mls/hr to continue over the post operative period. Intra-operatively the amount of local anaesthetic given will be under the maximum dose of 2 mg/kg. The maximum dose will not be reached even when the infusion commences due to the fact that time will have passed.
The primary outcome measures that will be used are to review pain scores using VAS on coughing. This will start at arrival in recovery room, which will be described as time zero. It will then be reviewed at time 1,2,4,6,12 and 24 hours. The pain scores are routinely measured by the nurses after this type of surgery, the only difference for the study will be that these scores are measured more often, a timer will be placed with the patient to indicate when the scores should be taken.
Secondary outcome measures will include morphine consumption, which will be noted peri-operatively then again at the time intervals described above. These will be recorded by the recovery staff initially and then continued by the ward nurses with the support of the research team.
Other secondary outcomes measured will include cortisol levels the following day, which will allow review of the neuroendocrine response. The patient will have routine blood tests the morning after the surgery; the cortisol level will be added to this test so the subject will not have extra blood taken. Patient satisfaction scores will be recorded in the form of a questionnaire and will be recorded on the first 2 post-operative days. The length of hospital stay, readmission at 30 days, survival at 30 days and infection rates will also be noted.
- Conditions
- Lung Tumour, Lung Metastases
- Being tested
- Early paravertebral block, Late Paravertebral block.
- Keywords
- VATS, Paravertebral blocks., Thoracoscopic surgery., Analgesia.
- Medical subject headings
- Lung Neoplasms, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early paravertebral blockProcedure or surgery
Also called Bupivicaine, Normal Saline, Propofol., Fentanyl.
In this group the local anaesthetic will be injected at the start of surgery soon after incision and normal saline at the end. These will be double blinded.
Late Paravertebral block.Procedure or surgery
Also called Bupivicaine, Normal Saline, Propofol., Fentanyl.
In the late group local anaesthetic will be injected at close of surgery with normal saline at the start. This will be double blinded.
| Study group | Role | What they receive |
|---|---|---|
| Early paravertebral block | Active comparator | The early group will have Local anaesthetic placed at the start of surgery and have normal saline placed at the close. Receives: Procedure: Early paravertebral block |
| Late paravertebral block | Active comparator | The late group will have normal saline placed at the start of surgery and local anaesthetic placed at the close. Receives: Procedure: Late Paravertebral block. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score on coughing using Visual Analogue Scale (VAS).
Pain scores in first 24 hours to be analysed using area under the curve.
Measured: 24 hours.
Secondary outcomes (6)
Morphine consumption
Amount of morphine used in first 24 hours via patient controlled analgesia.
Measured: 24 hours
Cortisol levels
Cortisol measured at routine blood tests after 24 hours.
Measured: 24 hours
Length of hospital stay
Patient's will be followed up for the duration of hospital stay, an expected average of 3 days.
Measured: 3 days (Average)
Patient satisfaction scores
Performed using questionnaires.
Measured: 24-48 hours
Readmission rates
Measured: 30 days
Survival
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung TumourStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals Bristol and Weston NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kajan Kamalanathan, BMBS, Principal investigator, United Hospitals Bristol NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01621698
- Sponsor's protocol ID
- AN/2012/4036
- Acronym
- ErLaPara
- Status last verified
- Sep 2015
- First submitted
- 8 Jun 2012
- Last updated
- 7 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Late Paravertebral Block for Analgesia in Video Assisted Thoracoscopic Lung Resection.
- ClinicalTrials.gov ID
- NCT01621698
- Acronym / sponsor ID
- ErLaPara / AN/2012/4036
- Conditions
- Lung Tumour, Lung Metastases
- Keywords
- VATS, Paravertebral blocks., Thoracoscopic surgery., Analgesia.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospitals Bristol and Weston NHS Foundation TrustUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 18 Jun 2012 (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.
This project involves looking at the timing of providing pain relief for patients who are having lung surgery via the use of a small camera inserted into the chest with a scope (Video assisted thorascopy). This procedure can be the source of intense pain both immediately after the procedure and in the longer term leading to chronic pain problems.
Local anaesthetic placed in the paravertebral space which is located adjacent to the spinal column, where the pain nerve fibres are located, is a well recognized method of providing pain relief for these procedures. It is currently unclear as to the best timings for providing this type of pain relief with some centres placing the local anaesthetic at the start of the procedure and some at the end. Placing a high volume of local anaesthetic into this area at the start of the case may provide better short and long term pain relief than placing it at the end of the procedure. The investigators hope to show a difference between the two timings to allow for better pain relief for these procedures. This would be a feasibility study that would lead onto a multicentre trial to eventually create a best practice protocol for pain relief for lung resection via this surgical method.
Detailed description
All patients will receive a general anaesthetic for their VATS procedure with full AAGBI monitoring and the WHO surgical safety checklist will be performed appropriately prior to skin incision. Induction of anaesthesia will be standardised by using propofol and the patient will be paralysed using the muscle relaxant atracurium. The amount given will be at the anaesthetist's discretion and dependent on the patient. Fentanyl at 2.5 mcg/kg will be used at induction of anaesthesia.
A double lumen endotracheal tube will be placed so lung isolation can be performed when necessary for the surgery. Anaesthesia will be maintained using a volatile agent or a target controlled infusion of propofol depending on the preference of the anaesthetist. The patient will be positioned laterally with the operative side up. All patients will receive simple intra-operative analgesia in the form of 1 gram of intravenous paracetamol and diclofenac unless the patient is over 70 or has abnormal renal function. Extra opioid analgesia will be given as intravenous morphine and this will be titrated by the anaesthetist. The amount given will be documented as part of the trial data.
Patients will be warmed to maintain a temperature between 36 and 37 degree Celsius using a warming blanket and warmed intravenous fluids. Anti-emetics in the form of ondansetron 4 mg and dexamethasone 4 mg will also be given unless there are any contraindications.
Prior to surgical incision patients in both groups will receive 1mg/kg 0.25% bupivicaine divided into 3 PV injections between the fifth and tenth thoracic vertebrae. Only trained anaesthetists with experience of over 30 PV insertions will perform the injections. The landmark technique for these injections is as follows: The spinous process of the thoracic vertebra is palpated by the anaesthetist, a 20 gauge needle is inserted 2.5 cm lateral to this and is advanced perpendicularly to the vertical and sagittal planes until the transverse process is contacted. The needle is then walked off the superior border of the transverse process, advanced a further 1 cm and one third of the weight determined local anaesthetic is delivered after careful aspiration.
Both groups will have a PV catheter placed at the start of the procedure and a bolus given straight away. As this is a double-blinded trial the anaesthetist will not know whether the bolus is local anaesthetic or saline solution.
Pharmacy at the research site will provide the 2 premade syringes that will contain either local anaesthetic or saline. The contents of the syringe will be unknown to the anaesthetist as the label will be simply numbered as 1 and 2 to be given in order as the early (1) or late (2) bolus. If it is clinically required to obtain information on what has been given a record will be immediately available from pharmacy. The syringes will be made up as neat 0.25% bupivicaine or 0.9% Normal Saline solution. The equivalent volume of 1mg/kg 0.25% bupivicaine will be injected as a bolus.
Both groups will also receive a 0.25mg/kg 0.25% bupivicaine intercostal block at closing and an infusion of 0.1% bupivicaine will then be commenced at 20mls/hr to continue over the post operative period. Intra-operatively the amount of local anaesthetic given will be under the maximum dose of 2 mg/kg. The maximum dose will not be reached even when the infusion commences due to the fact that time will have passed.
The primary outcome measures that will be used are to review pain scores using VAS on coughing. This will start at arrival in recovery room, which will be described as time zero. It will then be reviewed at time 1,2,4,6,12 and 24 hours. The pain scores are routinely measured by the nurses after this type of surgery, the only difference for the study will be that these scores are measured more often, a timer will be placed with the patient to indicate when the scores should be taken.
Secondary outcome measures will include morphine consumption, which will be noted peri-operatively then again at the time intervals described above. These will be recorded by the recovery staff initially and then continued by the ward nurses with the support of the research team.
Other secondary outcomes measured will include cortisol levels the following day, which will allow review of the neuroendocrine response. The patient will have routine blood tests the morning after the surgery; the cortisol level will be added to this test so the subject will not have extra blood taken. Patient satisfaction scores will be recorded in the form of a questionnaire and will be recorded on the first 2 post-operative days. The length of hospital stay, readmission at 30 days, survival at 30 days and infection rates will also be noted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early paravertebral block | Active comparator | Procedure: Early paravertebral blockThe early group will have Local anaesthetic placed at the start of surgery and have normal saline placed at the close. |
| Late paravertebral block | Active comparator | Procedure: Late Paravertebral block.The late group will have normal saline placed at the start of surgery and local anaesthetic placed at the close. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects will be recruited from patients admitted for elective VATS for lung resection.
- Patients aged 18 and over.
- Patient's will be ASA 1,2 or 3.
Key exclusion criteria (6 listed)
- Patient refusal.
- Emergency surgery.
- Patient unable to provide consent.
- Infection in paravertebral space.
- Patients who attend a chronic pain clinic on high doses of opiate drugs.
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 |
|---|---|---|
| Early paravertebral blockAlso: Bupivicaine, Normal Saline, Propofol., Fentanyl.In this group the local anaesthetic will be injected at the start of surgery soon after incision and normal saline at the end. These will be double blinded. | Procedure or surgery | Early paravertebral block |
| Late Paravertebral block.Also: Bupivicaine, Normal Saline, Propofol., Fentanyl.In the late group local anaesthetic will be injected at close of surgery with normal saline at the start. This will be double blinded. | Procedure or surgery | Late paravertebral block |
Primary outcome
Pain score on coughing using Visual Analogue Scale (VAS).
Time frame: 24 hours.
Pain scores in first 24 hours to be analysed using area under the curve.
6 secondary outcomes
Morphine consumption
Time frame: 24 hours
Cortisol levels
Time frame: 24 hours
Length of hospital stay
Time frame: 3 days (Average)
Patient satisfaction scores
Time frame: 24-48 hours
Readmission rates
Time frame: 30 days
Survival
Time frame: 30 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 7 Sep 2015.
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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.
Kajan Kamalanathan, BMBS principal investigator
United Hospitals Bristol NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early paravertebral block and Late Paravertebral block. in people with Lung Tumour and Lung Metastases, run by University Hospitals Bristol and Weston NHS Foundation Trust at 1 site in United Kingdom.
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 3 inclusion and 6 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 Sep 2015. 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 United Kingdom. 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?
Pain score on coughing using Visual Analogue Scale (VAS). (time frame: 24 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 7 Sep 2015.