Video-assisted Thoracoscopic Surgery (VATS)NCT07626489
Pre-incisional Infiltration With Ropivacaine Plus Diprospan for Relieving Postoperative Pain After Thoracoscopic Surgery
A study testing Pre-incisional infiltration with ropivacaine plus diprospan in people with Video-assisted Thoracoscopic Surgery (VATS) and Wedge Resection, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Video-assisted thoracoscopic surgery (VATS) is less invasive compared to traditional thoracotomy, but it is still reported that the incidence of acute pain following VATS exceeds 80%. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Video-assisted Thoracoscopic Surgery (VATS), Wedge Resection, Segmentectomy
- What is being tested?
- Pre-incisional infiltration with ropivacaine plus diprospan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2026to 30 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients scheduled for elective Video-assisted thoracoscopic surgery for wedge resection, segmentectomy and lobectomy of the lungs under general anesthesia;
- 8 to 64 years old
- American Society of Anesthesiologists (ASA) physical status of I-III
- Patients must be able to understand the nature and potential personal consequences of the clinical trial and cooperate with follow-up investigations
- signing of the informed consent form.
Who cannot join
- History of allergies to experimental drugs such as opioids or steroids;
- Alcohol abuse; Long term use of opioid drugs (exceeding 2 weeks or 3 days per week for more than 1 month); Suspected use of sedatives and analgesics; Use analgesic drugs within 24 hours before surgery; Patients undergoing steroid therapy;
- Serious neurological disorders, severe liver and kidney dysfunction, heart failure, etc;
- Unable to use pain assessment scale;
- Pregnant or lactating patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100070
Fang Luo, +86 13611326978, 13611326978@163.com
About this study
Official title: The Efficacy and Safety of Pre-incisional Infiltration With Ropivacaine Plus Diprospan in Patients Undergoing Video-assisted Thoracoscopic: a Multi-center Randomized Controlled Trial.
Video-assisted thoracoscopic surgery (VATS) is less invasive compared to traditional thoracotomy, but it is still reported that the incidence of acute pain following VATS exceeds 80%. Inadequate postoperative analgesia may trigger a series of adverse physiological stress responses, increase the occurrence of postoperative complications, and affect the rehabilitation process. If acute pain is not managed promptly and sufficiently, nearly one-quarter of patients may develop chronic pain, impacting normal life and sleep quality after discharge. Acute pain after VATS is mainly caused by the release of inflammatory mediators after soft tissue injury at the surgical site, which activates peripheral pain receptors and leads to abnormal action potentials transmitted along A δ and C fibers. Inflammatory mediators released from the soft tissues around incisions not only significantly alters the chemical microenvironment at the peripheral terminals of nociceptors, directly inducing pain, but also sensitizes afferent fibers, contributing to peripheral sensitization.
Incisional infiltration is the simplest, safest, and most effective anesthesia method for preventing incision pain after VATS, but even using long-acting local anesthetics, the effectiveness of postoperative analgesia can only last for a relatively short period of time. To improve the efficiency of local incision infiltration in postoperative analgesia, at least two issues need to be addressed: prolonging the duration of analgesia and reducing inflammation of nerve surrounding tissues. Numerous studies have shown that glucocorticoids not only can achieve anti-inflammatory and analgesic effects by inhibiting inflammatory cytokines and inflammatory responses but also can prolong the duration of action of local anesthetics. Preemptive incisional infiltration using local anesthetics with corticosteroids which have potent local anti-inflammatory properties may play a key role in preventing or reducing postoperative pain. The objective of this trial is to determine whether preemptive incisional infiltration with ropivacaine plus diprospan is superior to ropivacaine alone in relieving postoperative pain for adults undergoing VATS. The investigators also compare the effects of the two intervention measures on postoperative pain management, patient safety, and recovery quality.
- Conditions
- Video-assisted Thoracoscopic Surgery (VATS), Wedge Resection, Segmentectomy, Lobectomy, Infiltration Anesthesia
- Being tested
- Pre-incisional infiltration with ropivacaine plus diprospan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-incisional infiltration with ropivacaine plus diprospanDrug
Before the surgery, according to the surgeon's incision marking, the patients accept 0.5ml of diprospan (1ml diprospan: Betamethasone Dipropionate 5mg and Betamethasone Sodium Phosphate 2mg) plus 15ml of 1% ropivacaine diluted with 0.9% saline to a total volume of 30ml infiltrates the incision layer by layer (1ml subcutaneous infiltration at each location, 2ml full layer infiltration, total 3ml).
Pre-incisional infiltration with ropivacaine plus diprospanDrug
Before the surgery, according to the surgeon's incision marking, the patients accept 30ml of 0.5% ropivacaine infiltrates the incision layer by layer (1ml subcutaneous infiltration at each location, 2ml full layer infiltration, total 3ml).
| Study group | Role | What they receive |
|---|---|---|
| Pre-incisional infiltration with ropivacaine plus diprospan | Experimental | Before the surgery, according to the surgeon's incision marking, the patients accept 0.5ml of diprospan (1ml diprospan: Betamethasone Dipropionate 5mg and Betamethasone Sodium Phosphate 2mg) plus 15ml of 1% ropivacaine diluted with 0.9% saline to a total volume of 30ml infiltrates the incision layer by layer (1ml subcutaneous infiltration at each location, 2ml full layer infiltration, total 3ml). Receives: Drug: Pre-incisional infiltration with ropivacaine plus diprospan |
| Pre-incisional infiltration with ropivacaine alone | Active comparator | Before the surgery, according to the surgeon's incision marking, the patients accept 30ml of 0.5% ropivacaine infiltrates the incision layer by layer (1ml subcutaneous infiltration at each location, 2ml full layer infiltration, total 3ml). Receives: Drug: Pre-incisional infiltration with ropivacaine plus diprospan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively
Measured: The postoperative period 48 hours
Secondary outcomes (8)
Area Under the Curve (AUC) of Numeric Rating Scale at rest (NRSr) Within 0-72 Hours Postoperatively
scores of 1-3 indicate mild pain, 4-6 denote moderate pain, and 7-10 signify severe pain
Measured: Data will be collected at 4、12、24、36 and 72 hours postoperatively
Area under the curve (AUC) of the Numerical Rating Scale during movement (NRSm) within 0-72 hours postoperatively
The Numeric Rating Scale (NRS) designates 0 as representing no pain and 10 as representing the most severe pain, scores of 1-3 indicate mild pain, 4-6 denote moderate pain, and 7-10 signify severe pain.
Measured: Data will be collected at 4、12、24、36 and 72 hours postoperatively
Numeric Rating Scale at rest (NRSr) at 1 week, 1 month, and 3 months postoperatively
The Numeric Rating Scale (NRS) designates 0 as representing no pain and 10 as representing the most severe pain; scores of 1-3 indicate mild pain, 4-6 denote moderate pain, and 7-10 signify severe pain.
Measured: Postoperative day 7, month 1, and month 3.
Patient Satisfaction Scale(PSS)
Patient Satisfaction Scale(PSS) on a scale ranging from 0 to 10, where 0 denotes "completely dissatisfied" and 10 signifies "extremely satisfied".
Measured: Postoperative hours 4、12、24 and 48 hours.
Postoperative nausea and vomiting (PONV)
Measured on a scale of 0-3: 0 indicates no nausea, 1 indicates mild nausea that does not require treatment, 2 indicates nausea that requires treatment, and 3 indicates vomiting.
Measured: Postoperatively within 48 hours
Wound healing score
The wound healing score is evaluated by independent researchers based on the wound healing score table, which includes three aspects: skin healing, incision infection, and hair growth. The total score is obtained by adding up the three scores. Excellent wound healing: 3 points; Good wound healing is 4-5; Poor wound healing: total score greater than or equal to 6 points.
Measured: Postoperative 72 hours、1 and 3 months
Postoperatively and patient and observer scar assessment scale
Postoperatively and patient and observer scar assessment scale: the observer scores the scar based on the distribution of blood vessels around the incision, color, scar thickness, surface roughness, area, and softness. Each score ranges from 1 to 10 points and higher scores indicating more severe scars; The patient evaluates the scar based on whether there is pain or itching, color, softness, thickness, and self-perception. Each score range is also 1-10 points, with 1 point indicating no difference from normal skin and a higher score indicating more severe scars.
Measured: Postoperative 72 hours、1 and 3 months
Adverse events
Including local anesthetic poisoning, local hematoma, nausea and vomiting, itching, hypotension, arrhythmia, delirium, etc; Abnormal values in clinical laboratory tests, such as elevated blood glucose levels.
Measured: Within 72 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start30 May 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Video-assisted Thoracoscopic Surgery (VATS)Studies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fang Luo, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07626489
- Sponsor's protocol ID
- KY2025-338-02-6
- Status last verified
- Jun 2026
- First submitted
- 21 May 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Pre-incisional Infiltration With Ropivacaine Plus Diprospan in Patients Undergoing Video-assisted Thoracoscopic: a Multi-center Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07626489
- Acronym / sponsor ID
- KY2025-338-02-6
- Conditions
- Video-assisted Thoracoscopic Surgery (VATS), Wedge Resection, Segmentectomy, Lobectomy, Infiltration Anesthesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 30 May 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 4 Jun 2026 (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.
Video-assisted thoracoscopic surgery (VATS) is less invasive compared to traditional thoracotomy, but it is still reported that the incidence of acute pain following VATS exceeds 80%. Inadequate postoperative analgesia may trigger a series of adverse physiological stress responses, increase the occurrence of postoperative complications, and affect the rehabilitation process. If acute pain is not managed promptly and sufficiently, nearly one-quarter of patients may develop chronic pain, impacting normal life and sleep quality after discharge. Acute pain after VATS is mainly caused by the release of inflammatory mediators after soft tissue injury at the surgical site, which activates peripheral pain receptors and leads to abnormal action potentials transmitted along A δ and C fibers. Inflammatory mediators released from the soft tissues around incisions not only significantly alters the chemical microenvironment at the peripheral terminals of nociceptors, directly inducing pain, but also sensitizes afferent fibers, contributing to peripheral sensitization.
Incisional infiltration is the simplest, safest, and most effective anesthesia method for preventing incision pain after VATS, but even using long-acting local anesthetics, the effectiveness of postoperative analgesia can only last for a relatively short period of time. To improve the efficiency of local incision infiltration in postoperative analgesia, at least two issues need to be addressed: prolonging the duration of analgesia and reducing inflammation of nerve surrounding tissues. Numerous studies have shown that glucocorticoids not only can achieve anti-inflammatory and analgesic effects by inhibiting inflammatory cytokines and inflammatory responses but also can prolong the duration of action of local anesthetics. Preemptive incisional infiltration using local anesthetics with corticosteroids which have potent local anti-inflammatory properties may play a key role in preventing or reducing postoperative pain. The objective of this trial is to determine whether preemptive incisional infiltration with ropivacaine plus diprospan is superior to ropivacaine alone in relieving postoperative pain for adults undergoing VATS. The investigators also compare the effects of the two intervention measures on postoperative pain management, patient safety, and recovery quality.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-incisional infiltration with ropivacaine plus diprospan | Experimental | Drug: Pre-incisional infiltration with ropivacaine plus diprospanBefore the surgery, according to the surgeon's incision marking, the patients accept 0.5ml of diprospan (1ml diprospan: Betamethasone Dipropionate 5mg and Betamethasone Sodium Phosphate 2mg) plus 15ml of 1% ropivacaine diluted with 0.9% saline to a total volume of 30ml infiltrates the incision layer by layer (1ml subcutaneous infiltration at each location, 2ml full layer infiltration, total 3ml). |
| Pre-incisional infiltration with ropivacaine alone | Active comparator | Drug: Pre-incisional infiltration with ropivacaine plus diprospanBefore the surgery, according to the surgeon's incision marking, the patients accept 30ml of 0.5% ropivacaine infiltrates the incision layer by layer (1ml subcutaneous infiltration at each location, 2ml full layer infiltration, total 3ml). |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients scheduled for elective Video-assisted thoracoscopic surgery for wedge resection, segmentectomy and lobectomy of the lungs under general anesthesia;
- 8 to 64 years old
- American Society of Anesthesiologists (ASA) physical status of I-III
- Patients must be able to understand the nature and potential personal consequences of the clinical trial and cooperate with follow-up investigations
- signing of the informed consent form.
Key exclusion criteria (5 listed)
- History of allergies to experimental drugs such as opioids or steroids;
- Alcohol abuse; Long term use of opioid drugs (exceeding 2 weeks or 3 days per week for more than 1 month); Suspected use of sedatives and analgesics; Use analgesic drugs within 24 hours before surgery; Patients undergoing steroid therapy;
- Serious neurological disorders, severe liver and kidney dysfunction, heart failure, etc;
- Unable to use pain assessment scale;
- Pregnant or lactating patients.
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 |
|---|---|---|
| Pre-incisional infiltration with ropivacaine plus diprospanBefore the surgery, according to the surgeon's incision marking, the patients accept 0.5ml of diprospan (1ml diprospan: Betamethasone Dipropionate 5mg and Betamethasone Sodium Phosphate 2mg) plus 15ml of 1% ropivacaine diluted with 0.9% saline to a total volume of 30ml infiltrates the incision layer by layer (1ml subcutaneous infiltration at each location, 2ml full layer infiltration, total 3ml). | Drug | Pre-incisional infiltration with ropivacaine plus diprospan |
| Pre-incisional infiltration with ropivacaine plus diprospanBefore the surgery, according to the surgeon's incision marking, the patients accept 30ml of 0.5% ropivacaine infiltrates the incision layer by layer (1ml subcutaneous infiltration at each location, 2ml full layer infiltration, total 3ml). | Drug | Pre-incisional infiltration with ropivacaine alone |
Primary outcome
Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively
Time frame: The postoperative period 48 hours
8 secondary outcomes
Area Under the Curve (AUC) of Numeric Rating Scale at rest (NRSr) Within 0-72 Hours Postoperatively
Time frame: Data will be collected at 4、12、24、36 and 72 hours postoperatively
Area under the curve (AUC) of the Numerical Rating Scale during movement (NRSm) within 0-72 hours postoperatively
Time frame: Data will be collected at 4、12、24、36 and 72 hours postoperatively
Numeric Rating Scale at rest (NRSr) at 1 week, 1 month, and 3 months postoperatively
Time frame: Postoperative day 7, month 1, and month 3.
Patient Satisfaction Scale(PSS)
Time frame: Postoperative hours 4、12、24 and 48 hours.
Postoperative nausea and vomiting (PONV)
Time frame: Postoperatively within 48 hours
Wound healing score
Time frame: Postoperative 72 hours、1 and 3 months
Postoperatively and patient and observer scar assessment scale
Time frame: Postoperative 72 hours、1 and 3 months
Adverse events
Time frame: Within 72 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-incisional infiltration with ropivacaine plus diprospan in people with Video-assisted Thoracoscopic Surgery (VATS) and Wedge Resection, run by Beijing Tiantan Hospital 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 17 Jun 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fang Luo (+86 13611326978, 13611326978@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively (time frame: The postoperative period 48 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 17 Jun 2026.