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

NCT07591233 — Not applicable, Recruiting, 150 participants, Beijing Tiantan Hospital

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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.

RegistryNCT07591233
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, sequential, masking: quadruple, prevention
Enrollment150 (Estimated)
SponsorBeijing Tiantan Hospital (Other)
ConditionsLaparoscopic Surgery, Laparoscopic Cholecystectomy, Appendectomy, Laparoscopic, Hernia Repair
InterventionsPre-incisional infiltration with ropivacaine plus triamcinolone, Pre-incisional infiltration with ropivacaine alone (Drug)
Datesstart 2026-06-01, primary completion 2027-03-10 (estimated), completion 2028-05-30 (estimated), first posted 2026-05-15, last updated 2026-06-17
Locations1 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

-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. 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.

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+Arms and interventions

ArmTypeInterventionsDescription
Pre-incisional infiltration with ropivacaine plus triamcinoloneExperimentalDrug: Pre-incisional infiltration with ropivacaine plus triamcinolone
Pre-incisional infiltration with ropivacaine aloneActive comparatorDrug: Pre-incisional infiltration with ropivacaine alone
  • Pre-incisional infiltration with ropivacaine plus triamcinolone (Drug): 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).
  • Pre-incisional infiltration with ropivacaine alone (Drug): 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).

+Outcome measures

Primary outcomes

  • Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively [The postoperative period 48 hours]

Secondary outcomes

  • 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]: scores of 1-3 indicate mild pain, 4-6 denote moderate pain, and 7-10 signify severe pain
  • 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.]: 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.
  • Numeric Rating Scale at rest (NRSr) at 1 week, 1 month, and 3 months postoperatively [Postoperative day 7, month 1, and month 3.]: 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.
  • Patient Satisfaction Scale(PSS) [Postoperative hours 4、12、24 and 48 hours]: Patient Satisfaction Scale(PSS) on a scale ranging from 0 to 10, where 0 denotes "completely dissatisfied" and 10 signifies "extremely satisfied.
  • Postoperative nausea and vomiting(PONV) [Postoperatively within 48 hours]
  • wound healing score [Postoperative 72hours、1 and 3 months.]: The wound healing score is evaluated by independent researchers based on the wound healing score table, which 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 points; Good wound healing is 4-5; Poor wound healing: total score greater than or equal to 6 points.
  • Adverse events [Within 72 hours postoperatively]: 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.
  • postoperatively and patient and observer scar assessment scale [Postoperative 72 hours、1 and 3 months]: Postoperatively and patient and observer scar assessment scale: the observer scores the scar based on the distribution of blood vessels around the incision, color, scar thickness, surface roughness, area, and softness. Each score ranges from 1 to 10 points and higher scores indicating more severe scars; 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 points, with 1 point indicating no difference from normal skin and a higher score indicating more severe scars.

+Eligibility

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.

+Locations (1)

FacilityCityCountryStatus
Beijing Tiantan HospitalBeijing, Beijing MunicipalityChinaRecruiting