RecruitingNot ApplicableNCT07626463

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

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


Sponsor

Beijing Tiantan Hospital

Enrollment

150 participants

Start Date

May 30, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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. Studies have shown that up to 80% of patients experience postoperative pain following laparoscopic surgery due to inflammation caused by surgical incisions and surrounding tissues, necessitating pharmacological relief. Inflammatory mediators released from the soft tissues around laparoscopic 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. 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 laparoscopic surgery. The investigators also compare the effects of the two intervention measures on postoperative pain management, patient safety, and recovery quality.


Eligibility

Min Age: 18 YearsMax Age: 64 Years

Inclusion Criteria5

  • Patients scheduled for elective Laparoscopic Surgery for laparoscopic cholecystectomy, appendectomy, or hernia repair under general anesthesia;
  • Ages 18 to 64 years old;
  • American Society of Anesthesiologists (ASA) physical status of I-III;
  • Patients must be able to understand nature and potential personal; consequences of the clinical trial and cooperation with follow-up investigations;
  • signing of the informed consent form.

Exclusion Criteria7

  • 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.

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Interventions

DRUGPre-incisional infiltration with ropivacaine and 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).

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).


Locations(1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

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NCT07626463


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