Thoracic NeoplasmPhase 2/3ParaSOLNCT04209868
Preoperative Paravertebral Block in Cancer Surgery of the Lung
A Phase 2/3 study testing Levo-Bupivacaine Hydrochloride (HCl) 0.5 % in 20mL Injection and 0.9% Sodium Chloride 20mL Injection in people with Thoracic Neoplasm and Chronic Pain Post-Procedural, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The investigators aim to determine whether ultrasound-guided preemptive paravertebral blockade (PVB) local anaesthetic (pre-PVB LA), administered in addition to the post-operative PVB (post-PVB) local anaesthetic (LA) infusion, reduces acute postoperative pain, opioid requirement, chronic pain, and improves surgical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Neoplasm, Chronic Pain Post-Procedural, Acute Post-thoracotomy Pain
- What is being tested?
- Levo-Bupivacaine Hydrochloride (HCl) 0.5 % in 20mL Injection and 0.9% Sodium Chloride 20mL Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2019to 31 Dec 2024
- Phase
- Phase 2/3
- 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
- Elective radical primary lung cancer VATS surgery for single lobectomy
- American Society of Anesthesiology (ASA) I-III
- Age ≥18
Who cannot join
- Planned open thoracotomy, wedge resection, bilobectomy, pneumonectomy, chest wall resection or total pleurectomy
- Local anaesthetic or opioid allergy
- Coagulation disorders
- Inability to comply with study questionnaire completion
- Pre-existing pain in chest area or pre-existing pain conditions
- Local infection/tumour at proposed PVB site
- Previous lung surgery
- Planned surgery within 3 months of the primary lung resection
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Guy's Hospital, Great Maze Pond
London, SE1 9RT
Gill Arbane, 0207 188 8070, gill.arbane@gstt.nhs.uk
Cheng Ong, MBBS
About this study
Official title: Preoperative Paravertebral Block in Cancer Surgery of the Lung: ParaSOL a Prospective Randomized Controlled Clinical Trial
The investigators aim to determine whether ultrasound-guided preemptive paravertebral blockade (PVB) local anaesthetic (pre-PVB LA), administered in addition to the post-operative PVB (post-PVB) local anaesthetic (LA) infusion, reduces acute postoperative pain, opioid requirement, chronic pain, and improves surgical recovery, in thoracoscopic surgery for lung cancer.
Read the detailed description
In the UK, there has been an increase in lung cancer operations, especially in high risk and elderly patients, improving survival from 10.6% in 2008 to 15.1% in 2013. Lung cancer surgery is associated with severe acute pain, a high incidence of respiratory complications and chronic post-surgical pain. Severe acute postoperative pain is a strong predictor of CPSP. The improvement of perioperative outcomes in elderly patients, the benefits of regional anaesthesia and reduction of chronic pain are investigative priorities of the Anaesthesia and Perioperative Care Setting Partnership.
Enhanced recovery strategies include video-assisted thoracoscopic surgery (VATS), a minimally invasive alternative to open thoracotomy, which may be associated with less postoperative pain. Regional anaesthesia, by thoracic epidural analgesia (TEA) or PVB, is superior to systemic opioids in reducing acute pain after thoracotomy surgery.
Preemptive analgesia describes the aim of minimizing central spinal pain transmission by noxious stimuli arising from events at surgery, by administering an analgesic technique prior to surgical incision. Regional blockade affects central sensitization, allowing analgesia to outlast the pharmacological sensory blockade.
Compared to TEA initiated after surgery, acute pain severity is reduced by preemptive TEA. There are conflicting reports on the benefit of preemptive analgesia in other types of surgery, but TEA and PVB may prevent CPSP in thoracotomy and breast surgery. Some small studies have shown that pre-PVB reduces acute postoperative pain.
Paravertebral blockade is known to be as effective as TEA for acute postoperative analgesia following thoracic surgery, whilst having a lower incidence of pulmonary complications, hypotension and nausea. It is conventional practice in many centres for the surgical administration and placement of a catheter at the end of surgery for postoperative LA infusion (post-PVB) as the sole method of regional analgesia. Preoperative PVB is less common: anaesthetists may use a landmark technique, single or multiple injections and different volumes/strengths of LA.
Ultrasound guidance for pre-PVB injection increases accuracy. In an audit using this technique with post-PVB compared to post-PVB only, the investigators demonstrated reduced pain numerical rating scale (NRS) scores in elective VATS patients, (mean NRS at 24h 2.5 vs 4.5), and a reduction in the proportion of patients who experienced moderate-to-severe pain of NRS≥ 3 from 83% to 50% at 24h.
The investigators therefore aim to evaluate the contribution of ultrasound-guided pre-PVB, administered in addition to the post-PVB LA infusion, in reducing the severity of acute postoperative pain, perioperative opioid requirement, development of CPSP, and improving patient outcome in lung cancer patients undergoing VATS.
- Conditions
- Thoracic Neoplasm, Chronic Pain Post-Procedural, Acute Post-thoracotomy Pain, Anesthesia, Local
- Being tested
- Levo-Bupivacaine Hydrochloride (HCl) 0.5 % in 20mL Injection, 0.9% Sodium Chloride 20mL Injection
- Medical subject headings
- Thoracic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levo-Bupivacaine Hydrochloride (HCl) 0.5 % in 20mL InjectionDrug
As per arm description
0.9% Sodium Chloride 20mL InjectionDrug
As per arm description
| Study group | Role | What they receive |
|---|---|---|
| Pre-PVB with saline | Placebo comparator | Placebo (20ml Saline) pre-PVB performed post-induction and pre-incision. Receives: Drug: 0.9% Sodium Chloride 20mL Injection |
| Pre-PVB with 0.5% Levo-bupivacaine | Experimental | 20ml 0.5% Levo-bupivacaine pre-PVB performed post-induction and pre-incision. Receives: Drug: Levo-Bupivacaine Hydrochloride (HCl) 0.5 % in 20mL Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Moderate-to-severe pain Numerical Rating Scale (NRS) >/=3
The proportion of patients with clinical relevant moderate-to-severe pain (NRS>/=3) related to the surgical site at rest at 24 hours.
Measured: 1 day
Secondary outcomes (12)
Acute postoperative pain related to the surgical site as measured by a numerical rating scale (NRS) at rest and on coughing.
Acute postoperative pain related to the surgical site as measured by a numerical rating scale (NRS) at rest and on coughing, preoperatively, and after arrival in recovery at 1, 6, 24 and 48 hours
Measured: 1 hour
Acute postoperative pain related to the surgical site as measured by a numerical rating scale (NRS) at rest and on coughing.
Acute postoperative pain related to the surgical site as measured by a numerical rating scale (NRS) at rest and on coughing, preoperatively, and after arrival in recovery at 1, 6, 24 and 48 hours
Measured: 6 hours
Acute postoperative pain related to the surgical site as measured by a numerical rating scale (NRS) at rest and on coughing.
Acute postoperative pain related to the surgical site as measured by a numerical rating scale (NRS) at rest and on coughing, preoperatively, and after arrival in recovery at 1, 6, 24 and 48 hours
Measured: 24 hours
Acute postoperative pain related to the surgical site as measured by a numerical rating scale (NRS) at rest and on coughing.
Acute postoperative pain related to the surgical site as measured by a numerical rating scale (NRS) at rest and on coughing, preoperatively, and after arrival in recovery at 1, 6, 24 and 48 hours
Measured: 48 hours
Cumulative morphine requirement
Cumulative morphine requirement over 48 hours post arrival in recovery
Measured: 48 hours
Time to first mobilization
Time to first mobilization (walking 50 metres without the aid of another person), measured at baseline pre-operatively and postoperatively on daily assessment.
Measured: 3 days
Incidence of in-hospital complications
Incidence of in-hospital complications (Atrial Fibrillation (AF), Myocardial Infarction (MI), unplanned ICU admission) and respiratory complications, as defined by the Melbourne Group Scale.
Measured: 3 days
Length of hospital stay
Length of hospital stay (in days)
Measured: 3 days
Quality of Life (QoL) score
Quality of Life (QoL) score as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) version 3
Measured: Pre-operative and at 3 and 6 months post-operatively
Presence of chronic post-surgical pain
Presence of chronic post-surgical pain (CPSP) (binary yes/no) fulfilling CPSP criteria
Measured: Measured at 3 and 6 months post-operatively
Presence of chronic post-surgical pain
Presence of chronic post-surgical pain assessed by the Brief Pain Inventory Short Form (BPI-SF)
Measured: Measured at 3 and 6 months post-operatively
Presence of chronic post-surgical pain
Presence of chronic post-surgical pain assessed by as defined by the Melbourne Group Scale
Measured: Measured at 3 and 6 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start1 Feb 2019
- Primary completionDec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic NeoplasmStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be conducted at Guy's Hospital, London, United Kingdom (UK), a large tertiary thoracic centre for London, Sussex, Kent and Berkshire. In 2015, 459 lung cancer resection operations were performed; 8% of all lung cancer resections in England. Criteria for discontinuation/withdrawal or modifying allocated treatment: * Participant request to withdraw from the study. * Intraoperative identification of infection/tumour in paravertebral space Patient recruitment Eligible patients will be identified in the catchment outpatient clinics 4-6 weeks before surgery. The participant information sheet (PIS) will be introduced in the standard surgical booklet given by the surgeon. At the preoperative assessment clinic 2-3 weeks before surgery, a face-to-face discussion with the research nurse will support the PIS; the opportunity to ask any questions and contact a PPI (Patient and Public Involvement) representative and will be given. Written informed consent will be obtained.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cheng Ong, Study chair, Guys & St Thmas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04209868
- Sponsor's protocol ID
- 244680
- Acronym
- ParaSOL
- Status last verified
- Mar 2024
- First submitted
- 21 Nov 2019
- Last updated
- 29 Mar 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 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Paravertebral Block in Cancer Surgery of the Lung: ParaSOL a Prospective Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04209868
- Acronym / sponsor ID
- ParaSOL / 244680
- Conditions
- Thoracic Neoplasm, Chronic Pain Post-Procedural, Acute Post-thoracotomy Pain, Anesthesia, Local
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 24 Dec 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.
The investigators aim to determine whether ultrasound-guided preemptive paravertebral blockade (PVB) local anaesthetic (pre-PVB LA), administered in addition to the post-operative PVB (post-PVB) local anaesthetic (LA) infusion, reduces acute postoperative pain, opioid requirement, chronic pain, and improves surgical recovery, in thoracoscopic surgery for lung cancer.
Detailed description
In the UK, there has been an increase in lung cancer operations, especially in high risk and elderly patients, improving survival from 10.6% in 2008 to 15.1% in 2013. Lung cancer surgery is associated with severe acute pain, a high incidence of respiratory complications and chronic post-surgical pain. Severe acute postoperative pain is a strong predictor of CPSP. The improvement of perioperative outcomes in elderly patients, the benefits of regional anaesthesia and reduction of chronic pain are investigative priorities of the Anaesthesia and Perioperative Care Setting Partnership.
Enhanced recovery strategies include video-assisted thoracoscopic surgery (VATS), a minimally invasive alternative to open thoracotomy, which may be associated with less postoperative pain. Regional anaesthesia, by thoracic epidural analgesia (TEA) or PVB, is superior to systemic opioids in reducing acute pain after thoracotomy surgery.
Preemptive analgesia describes the aim of minimizing central spinal pain transmission by noxious stimuli arising from events at surgery, by administering an analgesic technique prior to surgical incision. Regional blockade affects central sensitization, allowing analgesia to outlast the pharmacological sensory blockade.
Compared to TEA initiated after surgery, acute pain severity is reduced by preemptive TEA. There are conflicting reports on the benefit of preemptive analgesia in other types of surgery, but TEA and PVB may prevent CPSP in thoracotomy and breast surgery. Some small studies have shown that pre-PVB reduces acute postoperative pain.
Paravertebral blockade is known to be as effective as TEA for acute postoperative analgesia following thoracic surgery, whilst having a lower incidence of pulmonary complications, hypotension and nausea. It is conventional practice in many centres for the surgical administration and placement of a catheter at the end of surgery for postoperative LA infusion (post-PVB) as the sole method of regional analgesia. Preoperative PVB is less common: anaesthetists may use a landmark technique, single or multiple injections and different volumes/strengths of LA.
Ultrasound guidance for pre-PVB injection increases accuracy. In an audit using this technique with post-PVB compared to post-PVB only, the investigators demonstrated reduced pain numerical rating scale (NRS) scores in elective VATS patients, (mean NRS at 24h 2.5 vs 4.5), and a reduction in the proportion of patients who experienced moderate-to-severe pain of NRS≥ 3 from 83% to 50% at 24h.
The investigators therefore aim to evaluate the contribution of ultrasound-guided pre-PVB, administered in addition to the post-PVB LA infusion, in reducing the severity of acute postoperative pain, perioperative opioid requirement, development of CPSP, and improving patient outcome in lung cancer patients undergoing VATS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study will be conducted at Guy's Hospital, London, United Kingdom (UK), a large tertiary thoracic centre for London, Sussex, Kent and Berkshire. In 2015, 459 lung cancer resection operations were performed; 8% of all lung cancer resections in England. Criteria for discontinuation/withdrawal or modifying allocated treatment: * Participant request to withdraw from the study. * Intraoperative identification of infection/tumour in paravertebral space Patient recruitment Eligible patients will be identified in the catchment outpatient clinics 4-6 weeks before surgery. The participant information sheet (PIS) will be introduced in the standard surgical booklet given by the surgeon. At the preoperative assessment clinic 2-3 weeks before surgery, a face-to-face discussion with the research nurse will support the PIS; the opportunity to ask any questions and contact a PPI (Patient and Public Involvement) representative and will be given. Written informed consent will be obtained.
| Arm | Type | Receives |
|---|---|---|
| Pre-PVB with saline | Placebo comparator | Drug: 0.9% Sodium Chloride 20mL InjectionPlacebo (20ml Saline) pre-PVB performed post-induction and pre-incision. |
| Pre-PVB with 0.5% Levo-bupivacaine | Experimental | Drug: Levo-Bupivacaine Hydrochloride (HCl) 0.5 % in 20mL Injection20ml 0.5% Levo-bupivacaine pre-PVB performed post-induction and pre-incision. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective radical primary lung cancer VATS surgery for single lobectomy
- American Society of Anesthesiology (ASA) I-III
- Age ≥18
Key exclusion criteria (8 listed)
- Planned open thoracotomy, wedge resection, bilobectomy, pneumonectomy, chest wall resection or total pleurectomy
- Local anaesthetic or opioid allergy
- Coagulation disorders
- Inability to comply with study questionnaire completion
- Pre-existing pain in chest area or pre-existing pain conditions
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 |
|---|---|---|
| Levo-Bupivacaine Hydrochloride (HCl) 0.5 % in 20mL InjectionAs per arm description | Drug | Pre-PVB with 0.5% Levo-bupivacaine |
| 0.9% Sodium Chloride 20mL InjectionAs per arm description | Drug | Pre-PVB with saline |
Primary outcome
Moderate-to-severe pain Numerical Rating Scale (NRS) >/=3
Time frame: 1 day
The proportion of patients with clinical relevant moderate-to-severe pain (NRS>/=3) related to the surgical site at rest at 24 hours.
12 secondary outcomes
Acute postoperative pain related to the surgical site as measured by a numerical rating scale (NRS) at rest and on coughing.
Time frame: 1 hour
Acute postoperative pain related to the surgical site as measured by a numerical rating scale (NRS) at rest and on coughing.
Time frame: 6 hours
Acute postoperative pain related to the surgical site as measured by a numerical rating scale (NRS) at rest and on coughing.
Time frame: 24 hours
Acute postoperative pain related to the surgical site as measured by a numerical rating scale (NRS) at rest and on coughing.
Time frame: 48 hours
Cumulative morphine requirement
Time frame: 48 hours
Time to first mobilization
Time frame: 3 days
Incidence of in-hospital complications
Time frame: 3 days
Length of hospital stay
Time frame: 3 days
Quality of Life (QoL) score
Time frame: Pre-operative and at 3 and 6 months post-operatively
Presence of chronic post-surgical pain
Time frame: Measured at 3 and 6 months post-operatively
Presence of chronic post-surgical pain
Time frame: Measured at 3 and 6 months post-operatively
Presence of chronic post-surgical pain
Time frame: Measured at 3 and 6 months post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 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.
Cheng Ong study chair
Guys & St Thmas' 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 Phase 2/3 study testing Levo-Bupivacaine Hydrochloride (HCl) 0.5 % in 20mL Injection and 0.9% Sodium Chloride 20mL Injection in people with Thoracic Neoplasm and Chronic Pain Post-Procedural, run by Guy's and St Thomas' 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 8 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: status not confirmed, as of the sponsor's last update on 29 Mar 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 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cheng Ong, MBBS (+44 2071887188, cheng.ong@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Moderate-to-severe pain Numerical Rating Scale (NRS) >/=3 (time frame: 1 day). 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 29 Mar 2024.