CClinicalTrials.gg
RecruitingNCT07603921Updated Sep 17, 2026

Pre-incisional Infiltration With Ropivacaine Plus Triamcinolone for Relieving Postoperative Pain After Thoracoscopic Surgery

An interventional study of Pre-incisional infiltration with ropivacaine plus triamcinolone and Pre-incisional infiltration with ropivacaine alone in Video-assisted Thoracoscopic Surgery (VATS), Wedge Resection and Segmentectomy, sponsored by Beijing Tiantan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Beijing Tiantan Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
346
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study 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%. 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 laparoscopic surgery 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. The investigators conducted a multicenter, prospective, randomized controlled clinical study to explore whether preemptive incisional infiltration with ropivacaine plus triamcinolone 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.

02

Conditions studied

  • Video-assisted Thoracoscopic Surgery (VATS)
  • Wedge Resection
  • Segmentectomy
  • Lobectomy of the Lungs
  • Incisional Infiltration
  • Triamcinolone
03

In context

Lead sponsor

Beijing Tiantan Hospital is the lead sponsor of 465 studies on the registry; 282 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients scheduled for elective thoracoscopic wedge resection, segmentectomy, and lobectomy under general anesthesia;
  2. Ages 18 to 64 years old
  3. American Society of Anesthesiologists (ASA) physical status of I-III
  4. Patients must be able to understand nature and potential personal consequences of the clinical trial and cooperation with follow-up investigations
  5. signing of the informed consent form.

Exclusion criteria

Exclusion Criteria:

  1. History of allergies to experimental drugs such as opioids or steroids;
  2. 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;
  3. Serious neurological disorders, severe liver and kidney dysfunction, heart failure, etc;
  4. Unable to use pain assessment scale;
  5. Pregnant or lactating patients.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
346 participants (estimated)

Study arms

  • Experimental
    Pre-incisional infiltration with 0.5%ropivacaine and triamcinolone 80mg

    Drug: Pre-incisional infiltration with ropivacaine plus triamcinolone

  • Active comparator
    Pre-incisional infiltration with 0.5% ropivacaine alone

    Drug: Pre-incisional infiltration with ropivacaine alone

Interventions

  • DrugPre-incisional infiltration with ropivacaine plus triamcinolone

    Before the surgery, according to the surgeon's incision marking, the patients accept 2ml of triamcinolone (80mg) 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).

  • DrugPre-incisional infiltration with ropivacaine alone

    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).

06

What researchers measure

Primary outcomes

  1. Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively

    Time frame: The postoperative period 48 hours

Secondary outcomes

  1. 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

    Time frame: Time Frame: Data will be collected at 4、12、24、36 and 72 hours postoperatively

  2. 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.

    Time frame: Data will be collected at 4、12、24、36 and 72 hours postoperatively

  3. 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.

    Time frame: Postoperative day 7, month 1, and month 3.

  4. 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".

    Time frame: Postoperative hours 4、12、24 and 48 hours

  5. Postoperative nausea and vomiting (PONV)

    The PONV score is expressed 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.

    Time frame: Postoperatively within 48 hours.

  6. wound healing score at 72 h, 1 and 3 months postoperatively and patient and observer scar assessment scale (POSAS) at 72 h, 1 and 3 months.

    The wound healing score 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; good wound: 4-5; poor wound healing: greater than or equal to 6 points. POSAS: the observer scores the scar based on the distribution of vessels, color, scar thickness, surface roughness, area, and softness around the incision, with each score ranging from 1 to 10. One indicates that the scar features are close to normal skin, and the higher the score, the more severe the scar (OSAS score); 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, with 1 indicating no difference from normal skin and a higher score indicating more severe scars. The higher the score between the two, the more severe the scar.

    Time frame: Postoperative 72 hours、1 and 3 months.

  7. 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.

    Time frame: Within 72 hours postoperatively

07

Study locations

1 of 1 sites recruiting
  • Beijing Tiantan Hospital
    Beijing, Beijing Municipality 100070, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07603921
Lead sponsor
Beijing Tiantan Hospital
Responsible party
Fang Luo (Director, Department of Day Surgery, Principal, Beijing Tiantan Hospital) — Principal investigator
First posted
May 22, 2026
Start date
Sep 1, 2026
Primary completion
May 31, 2027 (estimated)
Completion
Mar 31, 2028 (estimated)
Last update
Sep 17, 2026

Study contacts

Fang Luo
Contact
13611326978@163.com
+86 13611326978

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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