AnalgesiaPhase 3NCT06405724
Comparison of the Ultrasound-guided Paravertebral Nerve Block With Liposomal Bupivacaine Versus Ropivacaine for Post-Surgical Pain After Video-Assisted Thoracoscopic Surgery
A Phase 3 study testing Liposomal bupivacaine and Ropivacaine in people with Analgesia, run by Feng Gao at 1 site in China.
Trial summary
Prospective, randomized, and controlled trial to compare the postoperative pain management of paravertebral nerve block with liposomal bupivacaine to ropivacaine in patients undergoing elective thoracoscopic surgery. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Analgesia
- What is being tested?
- Liposomal bupivacaine and Ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2024to 21 Dec 2025
- Phase
- Phase 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-64 years old
- Elective unilateral thoracoscopic surgery
- Hospital stay ≥3 days
- Able to cooperate in completing interviews and scale assessments
- American Society of Anesthesiologists (ASA) classification I-III
- Signed informed consent form
Who cannot join
- History of thoracic surgery within the past 6 months
- Pre-existing history of chronic pain or acute pain in the surgical area
- Allergy to local anesthetics
- Contraindications to thoracic paravertebral nerve block
- Mental disorders, intellectual disabilities, epilepsy, or other neurological conditions
- Severe heart or lung diseases
Show all 9Show fewer
- History of opioid drug abuse or substance abuse
- Postoperative intubation
- Recent participation in other clinical studies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Ultrasound-guided Paravertebral Nerve Block With Liposomal Bupivacaine Versus Ropivacaine for Post-Surgical Pain After Video-Assisted Thoracoscopic Surgery:A Single-Center, Prospective, Randomized, and Controlled Trial
Prospective, randomized, and controlled trial to compare the postoperative pain management of paravertebral nerve block with liposomal bupivacaine to ropivacaine in patients undergoing elective thoracoscopic surgery.
Read the detailed description
The objective of this study is to validate the analgesic efficacy of liposomal bupivacaine (LB) compared with ropivacaine when injected for paravertebral nerve block (PVB) for video-assisted thoracoscopic surgery (VATS).
We hypothesize that LB will be superior to ropivacaine in terms of postoperative pain control following VATS. The primary outcome of this study will be NRS pain scores for resting pain and NRS pain scores for cough pain 24 hours following surgery. Secondary outcomes will include pain scores over the first 120 hours following surgery, opioid consumption, opioid-related adverse events, block-related adverse events, time of first getting out of bed, catheter indwelling time, postoperative hospitalization time, patient satisfaction, and chronic pain at 1, 3, and 6 months after surgery.
- Conditions
- Analgesia
- Being tested
- Liposomal bupivacaine, Ropivacaine
- Keywords
- paravertebral nerve block, liposomal bupivacaine, video-assisted thoracoscopic surgery
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal bupivacaineDrug
Also called Exparel
133mg LB 20mL thoracic paravertebral nerve block
RopivacaineDrug
0.5% ropivacaine 20mL thoracic paravertebral nerve block
| Study group | Role | What they receive |
|---|---|---|
| Drug: Liposomal bupivacaine | Experimental | Experimental group will receive PVB with LB 20 mL. Receives: Drug: Liposomal bupivacaine |
| Drug:ropivacaine | Active comparator | Comparator group will receive PVB with 20 mL of 0.5% ropivacaine Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score at rest
The pain score at rest will be assessed using the Numeric Rating Scale (NRS), which ranges from 0 (representing "no pain") to 10 (representing "the worst pain").
Measured: 24 hours after surgery
pain score during coughing
The pain score during coughing will be assessed using the Numeric Rating Scale (NRS), which ranges from 0 (representing "no pain") to 10 (representing "the worst pain").
Measured: 24 hours after surgery
Secondary outcomes (25)
pain score at rest
The pain score at rest will be assessed using the Numeric Rating Scale (NRS), which ranges from 0 (representing "no pain") to 10 (representing "the worst pain").
Measured: 6 hours after surgery
pain score during coughing
The pain score during coughing will be assessed using the Numeric Rating Scale (NRS), which ranges from 0 (representing "no pain") to 10 (representing "the worst pain").
Measured: 6 hours after surgery
pain score at rest
The pain score at rest will be assessed using the Numeric Rating Scale (NRS), which ranges from 0 (representing "no pain") to 10 (representing "the worst pain").
Measured: 48 hours after surgery
pain score during coughing
The pain score during coughing will be assessed using the Numeric Rating Scale (NRS), which ranges from 0 (representing "no pain") to 10 (representing "the worst pain").
Measured: 48 hours after surgery
pain score during coughing
The pain score during coughing will be assessed using the Numeric Rating Scale (NRS), which ranges from 0 (representing "no pain") to 10 (representing "the worst pain").
Measured: 72 hours after surgery
pain score at rest
The pain score at rest will be assessed using the Numeric Rating Scale (NRS), which ranges from 0 (representing "no pain") to 10 (representing "the worst pain").
Measured: 72 hours after surgery
pain score at rest
The pain score at rest will be assessed using the Numeric Rating Scale (NRS), which ranges from 0 (representing "no pain") to 10 (representing "the worst pain").
Measured: 96 hours after surgery
pain score during coughing
The pain score during coughing will be assessed using the Numeric Rating Scale (NRS), which ranges from 0 (representing "no pain") to 10 (representing "the worst pain").
Measured: 96 hours after surgery
pain score at rest
The pain score at rest will be assessed using the Numeric Rating Scale (NRS), which ranges from 0 (representing "no pain") to 10 (representing "the worst pain").
Measured: 120 hours after surgery
pain score during coughing
The pain score during coughing will be assessed using the Numeric Rating Scale (NRS), which ranges from 0 (representing "no pain") to 10 (representing "the worst pain").
Measured: 120 hours after surgery
Consumption of analgesic drugs
the amount of analgesic drugs will be recorded
Measured: 120 hours after surgery
Nerve block related adverse events
Any adverse event resulting from a nerve block, such as toxicity, allergic reactions, or nerve injuries, will be considered causally related.
Measured: 120 hours after surgery
Block duration: first reported pain
Definition: timing begins at block performance
Measured: 24 hours after surgery
Presence of pain 1 month after surgery assessed using the Brief Pain Inventory.
yes/no
Measured: 1 month after surgery
Presence of pain 3 months after surgery assessed using the Brief Pain Inventory.
yes/no
Measured: 3 months after surgery
Presence of pain 6 months after surgery assessed using the Brief Pain Inventory.
yes/no
Measured: 6 months after surgery
Hospital Anxiety and Depression Scale, HADS
The Hospital Anxiety and Depression Scale (HADS) is primarily used to screen for anxiety and depression in general hospital patients. The HADS includes a total of 14 items, with 7 items assessing depression and 7 items assessing anxiety. There are six reverse question entries, five on the depression subscale and one on the anxiety subscale.
Measured: day1 before surgery
Insomnia Severity Index, ISI
The Insomnia Severity Index (ISI) is a self-assessment tool for self-perception of insomnia symptoms in the past two weeks. It includes 7 items, with each item scoring 0 to 4 points. The questions involve the subject's subjective evaluation of sleep quality, including the severity of symptoms and their satisfaction with their sleep patterns. The impact of insomnia on daily functioning, the subject's awareness of the impact of insomnia on themselves, and the level of depression caused by sleep disorders.
Measured: day1 before surgery
Charlson Comorbidity Index, CCI
The Charlson Comorbidity Index (CCI) is a commonly used evaluation method in clinical research to assess the health status of patients and predict their life expectancy by scoring coexisting diseases and age.
Measured: day1 before surgery
Mini-cog
The Mini-Cog uses recall and clock-drawing tests to determine whether patients have cognitive impairments. A score of 0-2 indicates a positive dementia screening, while a score of 3-5 implies a negative screening, necessitating further evaluation.
Measured: day1 before surgery
Complications within 120hours after surgery
Complications will be recorded.
Measured: Five days after surgery
The douleur neuropathique 4 questionnaire(DN4)
This questionnaire serves as a diagnostic tool for identifying neuropathic pain. It comprises 10 options, consisting of 7 self-assessment items that evaluate symptoms. The total score is 10 points, and a score of ≥ 4 indicates the possibility of neuropathic pain, while a score < 4 rules out neuropathic pain.
Measured: day1 before surgery
The douleur neuropathique 4 questionnaire(DN4)
This questionnaire serves as a diagnostic tool for identifying neuropathic pain. It comprises 10 options, consisting of 7 self-assessment items that evaluate symptoms. The total score is 10 points, and a score of ≥ 4 indicates the possibility of neuropathic pain, while a score < 4 rules out neuropathic pain.
Measured: 1 month after surgery
The douleur neuropathique 4 questionnaire(DN4)
This questionnaire serves as a diagnostic tool for identifying neuropathic pain. It comprises 10 options, consisting of 7 self-assessment items that evaluate symptoms. The total score is 10 points, and a score of ≥ 4 indicates the possibility of neuropathic pain, while a score < 4 rules out neuropathic pain.
Measured: 3 months after surgery
The douleur neuropathique 4 questionnaire(DN4)
This questionnaire serves as a diagnostic tool for identifying neuropathic pain. It comprises 10 options, consisting of 7 self-assessment items that evaluate symptoms. The total score is 10 points, and a score of ≥ 4 indicates the possibility of neuropathic pain, while a score < 4 rules out neuropathic pain.
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start10 May 2024 (estimated)
- Primary completion21 Dec 2025 (estimated)
- Study completion21 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Feng Gao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Feng Gao, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06405724
- Sponsor's protocol ID
- TJ-IRB202403005
- Status last verified
- May 2024
- First submitted
- 5 May 2024
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Ultrasound-guided Paravertebral Nerve Block With Liposomal Bupivacaine Versus Ropivacaine for Post-Surgical Pain After Video-Assisted Thoracoscopic Surgery:A Single-Center, Prospective, Randomized, and Controlled Trial
- ClinicalTrials.gov ID
- NCT06405724
- Acronym / sponsor ID
- TJ-IRB202403005
- Conditions
- Analgesia
- Keywords
- paravertebral nerve block, liposomal bupivacaine, video-assisted thoracoscopic surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Feng GaoUniversity, hospital or other
- Study start
- 10 May 2024 (estimated)
- Primary completion
- 21 Dec 2025 (estimated)
- Study completion
- 21 Dec 2025 (estimated)
- First posted
- 8 May 2024 (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.
Prospective, randomized, and controlled trial to compare the postoperative pain management of paravertebral nerve block with liposomal bupivacaine to ropivacaine in patients undergoing elective thoracoscopic surgery.
Detailed description
The objective of this study is to validate the analgesic efficacy of liposomal bupivacaine (LB) compared with ropivacaine when injected for paravertebral nerve block (PVB) for video-assisted thoracoscopic surgery (VATS).
We hypothesize that LB will be superior to ropivacaine in terms of postoperative pain control following VATS. The primary outcome of this study will be NRS pain scores for resting pain and NRS pain scores for cough pain 24 hours following surgery. Secondary outcomes will include pain scores over the first 120 hours following surgery, opioid consumption, opioid-related adverse events, block-related adverse events, time of first getting out of bed, catheter indwelling time, postoperative hospitalization time, patient satisfaction, and chronic pain at 1, 3, and 6 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug: Liposomal bupivacaine | Experimental | Drug: Liposomal bupivacaineExperimental group will receive PVB with LB 20 mL. |
| Drug:ropivacaine | Active comparator | Drug: RopivacaineComparator group will receive PVB with 20 mL of 0.5% ropivacaine |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18-64 years old
- Elective unilateral thoracoscopic surgery
- Hospital stay ≥3 days
- Able to cooperate in completing interviews and scale assessments
- American Society of Anesthesiologists (ASA) classification I-III
Key exclusion criteria (9 listed)
- History of thoracic surgery within the past 6 months
- Pre-existing history of chronic pain or acute pain in the surgical area
- Allergy to local anesthetics
- Contraindications to thoracic paravertebral nerve block
- Mental disorders, intellectual disabilities, epilepsy, or other neurological 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 |
|---|---|---|
| Liposomal bupivacaineAlso: Exparel133mg LB 20mL thoracic paravertebral nerve block | Drug | Drug: Liposomal bupivacaine |
| Ropivacaine0.5% ropivacaine 20mL thoracic paravertebral nerve block | Drug | Drug:ropivacaine |
Primary outcome
pain score at rest
Time frame: 24 hours after surgery
The pain score at rest will be assessed using the Numeric Rating Scale (NRS), which ranges from 0 (representing "no pain") to 10 (representing "the worst pain").
pain score during coughing
Time frame: 24 hours after surgery
The pain score during coughing will be assessed using the Numeric Rating Scale (NRS), which ranges from 0 (representing "no pain") to 10 (representing "the worst pain").
25 secondary outcomes
pain score at rest
Time frame: 6 hours after surgery
pain score during coughing
Time frame: 6 hours after surgery
pain score at rest
Time frame: 48 hours after surgery
pain score during coughing
Time frame: 48 hours after surgery
pain score during coughing
Time frame: 72 hours after surgery
pain score at rest
Time frame: 72 hours after surgery
pain score at rest
Time frame: 96 hours after surgery
pain score during coughing
Time frame: 96 hours after surgery
pain score at rest
Time frame: 120 hours after surgery
pain score during coughing
Time frame: 120 hours after surgery
Consumption of analgesic drugs
Time frame: 120 hours after surgery
Nerve block related adverse events
Time frame: 120 hours after surgery
Block duration: first reported pain
Time frame: 24 hours after surgery
Presence of pain 1 month after surgery assessed using the Brief Pain Inventory.
Time frame: 1 month after surgery
Presence of pain 3 months after surgery assessed using the Brief Pain Inventory.
Time frame: 3 months after surgery
Presence of pain 6 months after surgery assessed using the Brief Pain Inventory.
Time frame: 6 months after surgery
Hospital Anxiety and Depression Scale, HADS
Time frame: day1 before surgery
Insomnia Severity Index, ISI
Time frame: day1 before surgery
Charlson Comorbidity Index, CCI
Time frame: day1 before surgery
Mini-cog
Time frame: day1 before surgery
Complications within 120hours after surgery
Time frame: Five days after surgery
The douleur neuropathique 4 questionnaire(DN4)
Time frame: day1 before surgery
The douleur neuropathique 4 questionnaire(DN4)
Time frame: 1 month after surgery
The douleur neuropathique 4 questionnaire(DN4)
Time frame: 3 months after surgery
The douleur neuropathique 4 questionnaire(DN4)
Time frame: 6 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Liposomal bupivacaine and Ropivacaine in people with Analgesia, run by Feng Gao at 1 site in China.
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 6 inclusion and 9 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 8 May 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 China. 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 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 Feng Gao, Doctor (13971587381 ext. 86, fgao@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain score at rest (time frame: 24 hours after surgery). 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 8 May 2024.