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The Efficacy and Safety of Pre-incisional Infiltration With Ropivacaine Plus Diprospan in Patients Undergoing Video-assisted Thoracoscopic: a Multi-center Randomized Controlled Trial.

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 64
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Beijing Tiantan Hospital
RECRUITING
Beijing
Contact Information
Primary
Fang Luo
13611326978@163.com
+86 13611326978
Time Frame
Start Date: 2026-05-30
Estimated Completion Date: 2028-05-30
Participants
Target number of participants: 100
Treatments
Experimental: Pre-incisional infiltration with ropivacaine plus diprospan
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).
Active_comparator: 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).
Sponsors
Leads: Beijing Tiantan Hospital

This content was sourced from clinicaltrials.gov

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