The Efficacy and Safety of Pre-incisional Infiltration With Ropivacaine Plus Triamcinolone for Postoperative Pain in Patients Undergoing Laparoscopic Surgery: a Multi-center Randomized Controlled Trial.
| Registry | NCT07591233 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, sequential, masking: quadruple, prevention |
| Enrollment | 150 (Estimated) |
| Sponsor | Beijing Tiantan Hospital (Other) |
| Conditions | Laparoscopic Surgery, Laparoscopic Cholecystectomy, Appendectomy, Laparoscopic, Hernia Repair |
| Interventions | Pre-incisional infiltration with ropivacaine plus triamcinolone, Pre-incisional infiltration with ropivacaine alone (Drug) |
| Dates | start 2026-06-01, primary completion 2027-03-10 (estimated), completion 2028-05-30 (estimated), first posted 2026-05-15, last updated 2026-06-17 |
| Locations | 1 site in China |
Related Papers Related Patents Related Grants Related Experts
All trials for Laparoscopic Surgery All trials for Laparoscopic Cholecystectomy All trials of Pre-incisional infiltration with ropivacaine plus triamcinolone All trials of Pre-incisional infiltration with ropivacaine alone
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. 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 triamcinolone is superior to ropivacaine alone in relieving postoperative pain for adults undergoing laparoscopic surgery. We also compare the effects of the two intervention measures on postoperative pain management, patient safety, and recovery quality.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Pre-incisional infiltration with ropivacaine plus triamcinolone | Experimental | Drug: Pre-incisional infiltration with ropivacaine plus triamcinolone | |
| Pre-incisional infiltration with ropivacaine alone | Active comparator | Drug: Pre-incisional infiltration with ropivacaine alone |
Sex: All, ages: 18 Years to 64 Years
Inclusion Criteria: 1. Patients scheduled for elective Laparoscopic Surgery for laparoscopic cholecystectomy, appendectomy, or hernia repair 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.
| Facility | City | Country | Status |
|---|---|---|---|
| Beijing Tiantan Hospital | Beijing, Beijing Municipality | China | Recruiting |