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

NCT07626489 | Not Yet Recruiting DMC

• 1 other identifier: KY2025-338-02-6
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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 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

Wedge Resection; Segmentectomy; Infiltration Anesthesia; Video-assisted Thoracoscopic Surgery (VATS); Lobectomy

Outcome Measures

Primary Outcomes (1)

• Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively

  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

  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

  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

  Postoperative day 7, month 1, and month 3.

• Patient Satisfaction Scale(PSS)

  Postoperative hours 4、12、24 and 48 hours.

• Postoperative nausea and vomiting (PONV)

  Postoperatively within 48 hours

Study Arms (2)

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).

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).

Drug: Pre-incisional infiltration with ropivacaine plus diprospan

Interventions

Pre-incisional infiltration with ropivacaine plus diprospan DRUG

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 diprospan

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients scheduled for elective Video-assisted thoracoscopic surgery for wedge resection, segmentectomy and lobectomy of the lungs under general anesthesia;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

MeSH Terms

Interventions

Ropivacaine; betamethasone dipropionate, betamethasone sodium phosphate drug combination

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Fang Luo

CONTACT

+86 13611326978; 13611326978@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Day Surgery, Principal

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 4, 2026
• Study Start: May 30, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 30, 2028
• Last Updated: June 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL