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

The Efficacy and Safety of Pre-incisional Infiltration With Ropivacaine Plus Triamcinolone 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 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.

Study Overview

• Status: Recruiting
• Conditions: Segmentectomy; Video-assisted Thoracoscopic Surgery (VATS); Wedge Resection; Triamcinolone; Lobectomy of the Lungs; Incisional Infiltration
• Intervention / Treatment: Drug: Pre-incisional infiltration with ropivacaine plus triamcinolone; Drug: Pre-incisional infiltration with ropivacaine alone

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fang Luo; Phone Number: +86 13611326978; Email: 13611326978@163.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100070
      • Recruiting
      • Beijing Tiantan Hospital
      • Contact: Fang Luo; Phone Number: +86 13611326978; Email: 13611326978@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pre-incisional infiltration with 0.5%ropivacaine and triamcinolone 80mg	Drug: Pre-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).
Active Comparator: Pre-incisional infiltration with 0.5% ropivacaine alone	Drug: Pre-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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively	The postoperative period 48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Postoperative day 7, month 1, and month 3.
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.	Within 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.	Data will be collected at 4、12、24、36 and 72 hours postoperatively
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: Data will be collected at 4、12、24、36 and 72 hours postoperatively
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".	Postoperative hours 4、12、24 and 48 hours
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.	Postoperatively within 48 hours.
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.	Postoperative 72 hours、1 and 3 months.

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: May 11, 2026
• First Submitted That Met QC Criteria: May 17, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 15, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Polycyclic Compounds; Anilides; Amides; Aniline Compounds; Amines; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Ropivacaine; Triamcinolone
• Other Study ID Numbers: KY2025-338-02-4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No