Post Operative PainNCT05812521
Thoracic Paravertebral Block With Methylene Blue Visual Confirmation for Postoperative Pain After VATS Lobectomy
A study testing Paravertebral block with methylene blue and Thoracic Epidural Anesthesia in people with Post Operative Pain and Thoracic Cancer, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial summary
The goal of this study is to compare the efficacy in controlling postoperative pain of paravertebral block (PVB) with methylene blue visual confirmation and thoracic epidural anesthesia (TEA). This is a single center, parallel-group, prospective study. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Post Operative Pain, Thoracic Cancer
- What is being tested?
- Paravertebral block with methylene blue and Thoracic Epidural Anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jan 2020to 16 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
- Males and females aged 18 - 85 years old
- scheduled to undergo thoracoscopic lobectomy for lung cancer
- standardized three-port anterior thoracoscopic approach
Who cannot join
- Allergy to any of the drugs used in the study
- Previous thoracic surgical procedures or lung resection
- Psychiatric disorders
- ASA (American Society of Anesthesiologists) Class > III
- Conversion to thoracotomy
- Lack of written informed consent
- Participation to other studies
- Contraindications to epidural analgesia or paravertebral block
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Thoracic Paravertebral Block With Methylene Blue Visual Confirmation in the Management of Postoperative Pain After Video-assisted Thoracoscopic Lobectomy
The goal of this study is to compare the efficacy in controlling postoperative pain of paravertebral block (PVB) with methylene blue visual confirmation and thoracic epidural anesthesia (TEA). This is a single center, parallel-group, prospective study. Patients will be randomly assigned in a 1:1 ratio to receive either PVB or TEA. Primary end-point is pain relief measured with Postoperative Numeric Rating Scale. The secondary end-points are time to perform TEA and PVB, total opioid consumption, postoperative outcomes.
Read the detailed description
The management of postoperative pain in patients undergoing thoracoscopic lobectomy is a fundamental part of the process of recovery. Uncontrolled thoracic pain in the early postoperative period may interfere with the mobilization of the patients, leading to increased morbidity and reduction in the quality of life.
Thoracic paravertebral block (PVB) is an effective strategy for controlling postoperative pain after video-assisted thoracoscopic (VATS) lobectomy, but it may be subjected to a high rate of failure due to incorrect identification of the site of local anesthetic injection.
Thoracic epidural anesthesia (TEA) is considered a reliable technique for regional thoracic anesthesia, however potential side effects may limit its use.
Herein the investigators reported a new technique using methylene blue as a visual confirmation of the correct anesthetic diffusion during PVB. Then, the investigators will compare the efficacy of methylene blue PVB with TEA for the management of postoperative pain in patients undergoing VATS lobectomy.
This is a single center, parallel-group, prospective study. Participants will be randomly assigned in a 1:1 ratio to receive either PVB with methylene blue or TEA.
All participants will receive postoperatively intravenous acetaminophen as additional analgesics and intravenous tramadol as rescue analgesic. Primary end-point is pain relief measured with Postoperative Numeric Rating Scale at at 1, 12, 24, 48 hours postoperatively. The secondary end-points are: (i) time to perform TEA and PVB, (ii) total opioid consumption, (iii) postoperative outcomes (including complications, chest drainage duration and length of hospital stay).
- Conditions
- Post Operative Pain, Thoracic Cancer
- Being tested
- Paravertebral block with methylene blue, Thoracic Epidural Anesthesia
- Keywords
- postoperative pain, regional anesthesia, thoracoscopy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paravertebral block with methylene blueProcedure or surgery
The paravertebral space is identified under ultrasound guidance and after negative aspiration a 3 ml test dose of anesthetic is injected. After observing widening of the paravertebral space and anterior pleural displacement to confirm the correct needle positioning, a bolus dose of 20 mL 0.5% ropivacaine with a solution of 1 ml 1% methylene blue and 4 ml of saline will be injected in the paravertebral space. At the start of the surgery, the spread of the solution of anesthetic and methylene blue will be assessed through visualization in thoracoscopy and if necessary the block will be repeated. After the surgery, intravenous acetaminophen will be administered 3 times daily and tramadol 50 mg will be prescribed as rescue analgesic.
Thoracic Epidural AnesthesiaProcedure or surgery
The epidural catheter will be placed using the loss of resistance technique, and after ruling out intravenous or intrathecal catheter placement with a negative aspiration test dose, an initial dose of 10 mL 0.25% bupivacaine will be injected. Continuous infusion will be started with with 0.125 % bupivacaine + fentanyl 0.5 mcg/ ml at 6-10 ml/hour will be started based on the patient weight for 48 hours postoperatively. After the surgery, intravenous acetaminophen will be administered 3 times daily and tramadol 50 mg will be prescribed as rescue analgesic.
| Study group | Role | What they receive |
|---|---|---|
| Paravertebral block with methylene blue | Experimental | With the patient sitting, the patient will receive paravertebral block at T4-T5 level before general anesthesia induction Receives: Procedure: Paravertebral block with methylene blue |
| Thoracic Epidural Anesthesia | Active comparator | With the patient sitting, the patient will receive thoracic epidural anesthesia at T4-T8 level before general anesthesia induction Receives: Procedure: Thoracic Epidural Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Pain Scores on the Postoperative Numeric Rating Scale in the first 48 hours postoperatively
Pain scores at rest and after cough will be evaluated in the first 48 hours postoperatively using Postoperative Numeric Rating Scale (NRS) ranging from 0 (absence of pain) to 10 (maximum level of pain)
Measured: 1 hours, 12 hours, 24 hours and 48 hours after surgery
Secondary outcomes (4)
Opioids consumption
Cumulative dose of intravenous opioids administered as rescue analgesic will be registered during the post-operative period.
Measured: through the entire hospital stay, an average of 8 days"
Time to perform PVB or TEA
Time needed to perform PVB or TEA will be recorded
Measured: From the identification of the site of injection to the start of general anesthesia, up to 1 hour
Chest tube duration
Total days of chest tube duration will be recorded
Measured: From chest tube placement to chest tube removal, up to 20 days
Length of hospital stay
Total days of hospital stay will be recorded
Measured: From hospital admission to discharge, up to 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start15 Jan 2020
- Primary completion20 Nov 2022
- Study completion16 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Post Operative PainStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfonso Fiorelli, University of Campania Luigi Vanvitelli
- Investigators
- Alfonso Fiorelli, MD, PhD, Principal investigator, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05812521
- Sponsor's protocol ID
- 29917/2022
- Status last verified
- Apr 2023
- First submitted
- 19 Mar 2023
- Last updated
- 13 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yeap YL, Wolfe JW, Backfish-White KM, Young JV, Stewart J, Ceppa DP, Moser EAS, Birdas TJ. Randomized Prospective Study Evaluating Single-Injection Paravertebral Block, Paravertebral Catheter, and Thoracic Epidural Catheter for Postoperative Regional Analgesia After Video-Assisted Thoracoscopic Surgery. J Cardiothorac Vasc Anesth. 2020 Jul;34(7):1870-1876. doi: 10.1053/j.jvca.2020.01.036. Epub 2020 Jan 25.
PubMed 32144059D'Ercole F, Arora H, Kumar PA. Paravertebral Block for Thoracic Surgery. J Cardiothorac Vasc Anesth. 2018 Apr;32(2):915-927. doi: 10.1053/j.jvca.2017.10.003. Epub 2017 Oct 4.
PubMed 29169795Norum HM, Breivik H. A systematic review of comparative studies indicates that paravertebral block is neither superior nor safer than epidural analgesia for pain after thoracotomy. Scand J Pain. 2010 Jan 1;1(1):12-23. doi: 10.1016/j.sjpain.2009.10.003.
PubMed 29913936Baidya DK, Khanna P, Maitra S. Analgesic efficacy and safety of thoracic paravertebral and epidural analgesia for thoracic surgery: a systematic review and meta-analysis. Interact Cardiovasc Thorac Surg. 2014 May;18(5):626-35. doi: 10.1093/icvts/ivt551. Epub 2014 Jan 31.
PubMed 24488821Casati A, Alessandrini P, Nuzzi M, Tosi M, Iotti E, Ampollini L, Bobbio A, Rossini E, Fanelli G. A prospective, randomized, blinded comparison between continuous thoracic paravertebral and epidural infusion of 0.2% ropivacaine after lung resection surgery. Eur J Anaesthesiol. 2006 Dec;23(12):999-1004. doi: 10.1017/S0265021506001104. Epub 2006 Jul 7.
PubMed 16824243Helms O, Mariano J, Hentz JG, Santelmo N, Falcoz PE, Massard G, Steib A. Intra-operative paravertebral block for postoperative analgesia in thoracotomy patients: a randomized, double-blind, placebo-controlled study. Eur J Cardiothorac Surg. 2011 Oct;40(4):902-6. doi: 10.1016/j.ejcts.2011.01.067. Epub 2011 Mar 5.
PubMed 21377888Ding X, Jin S, Niu X, Ren H, Fu S, Li Q. A comparison of the analgesia efficacy and side effects of paravertebral compared with epidural blockade for thoracotomy: an updated meta-analysis. PLoS One. 2014 May 5;9(5):e96233. doi: 10.1371/journal.pone.0096233. eCollection 2014.
PubMed 24797238Marshall K, McLaughlin K. Pain Management in Thoracic Surgery. Thorac Surg Clin. 2020 Aug;30(3):339-346. doi: 10.1016/j.thorsurg.2020.03.001. Epub 2020 Apr 29.
PubMed 32593366
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Thoracic Paravertebral Block With Methylene Blue Visual Confirmation in the Management of Postoperative Pain After Video-assisted Thoracoscopic Lobectomy
- ClinicalTrials.gov ID
- NCT05812521
- Acronym / sponsor ID
- 29917/2022
- Conditions
- Post Operative Pain, Thoracic Cancer
- Keywords
- postoperative pain, regional anesthesia, thoracoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 20 Nov 2022 (actual)
- Study completion
- 16 Dec 2022 (actual)
- First posted
- 13 Apr 2023 (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 goal of this study is to compare the efficacy in controlling postoperative pain of paravertebral block (PVB) with methylene blue visual confirmation and thoracic epidural anesthesia (TEA). This is a single center, parallel-group, prospective study. Patients will be randomly assigned in a 1:1 ratio to receive either PVB or TEA. Primary end-point is pain relief measured with Postoperative Numeric Rating Scale. The secondary end-points are time to perform TEA and PVB, total opioid consumption, postoperative outcomes.
Detailed description
The management of postoperative pain in patients undergoing thoracoscopic lobectomy is a fundamental part of the process of recovery. Uncontrolled thoracic pain in the early postoperative period may interfere with the mobilization of the patients, leading to increased morbidity and reduction in the quality of life.
Thoracic paravertebral block (PVB) is an effective strategy for controlling postoperative pain after video-assisted thoracoscopic (VATS) lobectomy, but it may be subjected to a high rate of failure due to incorrect identification of the site of local anesthetic injection.
Thoracic epidural anesthesia (TEA) is considered a reliable technique for regional thoracic anesthesia, however potential side effects may limit its use.
Herein the investigators reported a new technique using methylene blue as a visual confirmation of the correct anesthetic diffusion during PVB. Then, the investigators will compare the efficacy of methylene blue PVB with TEA for the management of postoperative pain in patients undergoing VATS lobectomy.
This is a single center, parallel-group, prospective study. Participants will be randomly assigned in a 1:1 ratio to receive either PVB with methylene blue or TEA.
All participants will receive postoperatively intravenous acetaminophen as additional analgesics and intravenous tramadol as rescue analgesic. Primary end-point is pain relief measured with Postoperative Numeric Rating Scale at at 1, 12, 24, 48 hours postoperatively. The secondary end-points are: (i) time to perform TEA and PVB, (ii) total opioid consumption, (iii) postoperative outcomes (including complications, chest drainage duration and length of hospital stay).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paravertebral block with methylene blue | Experimental | Procedure: Paravertebral block with methylene blueWith the patient sitting, the patient will receive paravertebral block at T4-T5 level before general anesthesia induction |
| Thoracic Epidural Anesthesia | Active comparator | Procedure: Thoracic Epidural AnesthesiaWith the patient sitting, the patient will receive thoracic epidural anesthesia at T4-T8 level before general anesthesia induction |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and females aged 18 - 85 years old
- scheduled to undergo thoracoscopic lobectomy for lung cancer
- standardized three-port anterior thoracoscopic approach
Key exclusion criteria (8 listed)
- Allergy to any of the drugs used in the study
- Previous thoracic surgical procedures or lung resection
- Psychiatric disorders
- ASA (American Society of Anesthesiologists) Class > III
- Conversion to thoracotomy
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 |
|---|---|---|
| Paravertebral block with methylene blueThe paravertebral space is identified under ultrasound guidance and after negative aspiration a 3 ml test dose of anesthetic is injected. After observing widening of the paravertebral space and anterior pleural displacement to confirm the correct needle positioning, a bolus dose of 20 mL 0.5% ropivacaine with a solution of 1 ml 1% methylene blue and 4 ml of saline will be injected in the paravertebral space. At the start of the surgery, the spread of the solution of anesthetic and methylene blue will be assessed through visualization in thoracoscopy and if necessary the block will be repeated. After the surgery, intravenous acetaminophen will be administered 3 times daily and tramadol 50 mg will be prescribed as rescue analgesic. | Procedure or surgery | Paravertebral block with methylene blue |
| Thoracic Epidural AnesthesiaThe epidural catheter will be placed using the loss of resistance technique, and after ruling out intravenous or intrathecal catheter placement with a negative aspiration test dose, an initial dose of 10 mL 0.25% bupivacaine will be injected. Continuous infusion will be started with with 0.125 % bupivacaine + fentanyl 0.5 mcg/ ml at 6-10 ml/hour will be started based on the patient weight for 48 hours postoperatively. After the surgery, intravenous acetaminophen will be administered 3 times daily and tramadol 50 mg will be prescribed as rescue analgesic. | Procedure or surgery | Thoracic Epidural Anesthesia |
Primary outcome
Change From Baseline in Pain Scores on the Postoperative Numeric Rating Scale in the first 48 hours postoperatively
Time frame: 1 hours, 12 hours, 24 hours and 48 hours after surgery
Pain scores at rest and after cough will be evaluated in the first 48 hours postoperatively using Postoperative Numeric Rating Scale (NRS) ranging from 0 (absence of pain) to 10 (maximum level of pain)
4 secondary outcomes
Opioids consumption
Time frame: through the entire hospital stay, an average of 8 days"
Time to perform PVB or TEA
Time frame: From the identification of the site of injection to the start of general anesthesia, up to 1 hour
Chest tube duration
Time frame: From chest tube placement to chest tube removal, up to 20 days
Length of hospital stay
Time frame: From hospital admission to discharge, up to 20 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 13 Apr 2023.
- Background: PubMed 32144059Yeap YL, Wolfe JW, Backfish-White KM, Young JV, Stewart J, Ceppa DP, Moser EAS, Birdas TJ. Randomized Prospective Study Evaluating Single-Injection Paravertebral Block, Paravertebral Catheter, and Thoracic Epidural Catheter for Postoperative Regional Analgesia After Video-Assisted Thoracoscopic Surgery. J Cardiothorac Vasc Anesth. 2020 Jul;34(7):1870-1876. doi: 10.1053/j.jvca.2020.01.036. Epub 2020 Jan 25.
- Background: PubMed 29169795D'Ercole F, Arora H, Kumar PA. Paravertebral Block for Thoracic Surgery. J Cardiothorac Vasc Anesth. 2018 Apr;32(2):915-927. doi: 10.1053/j.jvca.2017.10.003. Epub 2017 Oct 4.
- Background: PubMed 29913936Norum HM, Breivik H. A systematic review of comparative studies indicates that paravertebral block is neither superior nor safer than epidural analgesia for pain after thoracotomy. Scand J Pain. 2010 Jan 1;1(1):12-23. doi: 10.1016/j.sjpain.2009.10.003.
- Background: PubMed 24488821Baidya DK, Khanna P, Maitra S. Analgesic efficacy and safety of thoracic paravertebral and epidural analgesia for thoracic surgery: a systematic review and meta-analysis. Interact Cardiovasc Thorac Surg. 2014 May;18(5):626-35. doi: 10.1093/icvts/ivt551. Epub 2014 Jan 31.
- Background: PubMed 16824243Casati A, Alessandrini P, Nuzzi M, Tosi M, Iotti E, Ampollini L, Bobbio A, Rossini E, Fanelli G. A prospective, randomized, blinded comparison between continuous thoracic paravertebral and epidural infusion of 0.2% ropivacaine after lung resection surgery. Eur J Anaesthesiol. 2006 Dec;23(12):999-1004. doi: 10.1017/S0265021506001104. Epub 2006 Jul 7.
- Background: PubMed 21377888Helms O, Mariano J, Hentz JG, Santelmo N, Falcoz PE, Massard G, Steib A. Intra-operative paravertebral block for postoperative analgesia in thoracotomy patients: a randomized, double-blind, placebo-controlled study. Eur J Cardiothorac Surg. 2011 Oct;40(4):902-6. doi: 10.1016/j.ejcts.2011.01.067. Epub 2011 Mar 5.
- Background: PubMed 24797238Ding X, Jin S, Niu X, Ren H, Fu S, Li Q. A comparison of the analgesia efficacy and side effects of paravertebral compared with epidural blockade for thoracotomy: an updated meta-analysis. PLoS One. 2014 May 5;9(5):e96233. doi: 10.1371/journal.pone.0096233. eCollection 2014.
- Background: PubMed 32593366Marshall K, McLaughlin K. Pain Management in Thoracic Surgery. Thorac Surg Clin. 2020 Aug;30(3):339-346. doi: 10.1016/j.thorsurg.2020.03.001. Epub 2020 Apr 29.
- Individual participant dataSharing planned: No
Related trials for Post Operative Pain
Recruiting
Radiofrequency Ablation for the Treatment of Post-knee Arthroplasty Chronic Pain.
Chronic Post-surgical Pain, Chronic Post Operative Pain
RecruitingPhase 4
Perioperative Rectal Methadone in Spine Surgery
Spinal Surgery, Post-operative Care
Not yet recruiting
Post-operative Pain and Apical Healing After Root Canal (re)Treatment With Laser-activated Irrigation Versus Sonic or no Activation
Apical Periodontitis, Post Operative Pain, Acute
Not yet recruitingPhase 4
Suzetrigine (Journavx) as Multimodal Therapy for Pain Management in Adults Undergoing Surgery for Hip Fracture
Hip Fractures (ICD-10 72.01-72.2), Post Operative Analgesia
Recruiting
Butyrate and Taurine for Chronic Postsurgical Pain in Adult Cardiac Surgical Patients
Pain, Acute, Pain, Chronic
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.
Alfonso Fiorelli, MD, PhD principal investigator
University of Campania Luigi Vanvitelli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paravertebral block with methylene blue and Thoracic Epidural Anesthesia in people with Post Operative Pain and Thoracic Cancer, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
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: finished, as of the sponsor's last update on 13 Apr 2023. 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 Italy. 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?
Change From Baseline in Pain Scores on the Postoperative Numeric Rating Scale in the first 48 hours postoperatively (time frame: 1 hours, 12 hours, 24 hours and 48 hours after surgery). 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 NCT05812521, which also lists 8 linked publications.
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 13 Apr 2023; AzTrials last refreshed its copy on 1 Nov 2026.