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

Official title

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

Overview

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.

Interventions

• Drug Pre-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).
• Drug 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).

Primary outcome measures

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

Secondary outcome measures (8)

• Area Under the Curve (AUC) of Numeric Rating Scale at rest (NRSr) Within 0-72 Hours Postoperatively [Time frame: 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 [Time frame: 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 [Time frame: Postoperative day 7, month 1, and month 3.]
• Patient Satisfaction Scale(PSS) [Time frame: Postoperative hours 4、12、24 and 48 hours]
• Postoperative nausea and vomiting (PONV) [Time frame: Postoperatively within 48 hours]
• Wound healing score [Time frame: Postoperative 72 hours、1 and 3 months]
• Adverse events [Time frame: Within 72 hours postoperatively]
• Postoperatively and patient and observer scar assessment scale [Time frame: Postoperative 72 hours、1 and 3 months]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Prevention

Study locations

China · 1 center

• Beijing Tiantan Hospital — Beijing

Identifiers

NCT: NCT07626463 · KY2025-338-02-5

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗