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

N/ANot Yet RecruitingNCT07626463

Beijing Tiantan Hospital150 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

150

Conditions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

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; 3. Use analgesic drugs within 24 hours before surgery; 4. Patients undergoing steroid therapy; 5. Serious neurological disorders, severe liver and kidney dysfunction, heart failure, etc; 6. Unable to use pain assessment scale; 7. Pregnant or lactating patients.

Outcomes

Primary Outcomes

Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively

Time frame: The postoperative period 48 hours

Secondary Outcomes

Area Under the Curve (AUC) of Numeric Rating Scale at rest (NRSr) Within 0-72 Hours Postoperatively

Description: scores of 1-3 indicate mild pain, 4-6 denote moderate pain, and 7-10 signify severe pain

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

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.

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

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.

Time frame: Postoperative day 7, month 1, and month 3.

Patient Satisfaction Scale(PSS)

Patient Satisfaction Scale(PSS) on a scale ranging from 0 to 10, where 0 denotes "completely dissatisfied" and 10 signifies "extremely satisfied".

Time frame: Postoperative hours 4、12、24 and 48 hours

Postoperative nausea and vomiting (PONV)

Measured on a scale of 0-3: 0 indicates no nausea, 1 indicates mild nausea that does not require treatment, 2 indicates nausea that requires treatment, and 3 indicates vomiting.

Time frame: Postoperatively within 48 hours

Wound healing score

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.

Time frame: Postoperative 72 hours、1 and 3 months

Adverse events

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.

Time frame: Within 72 hours postoperatively

Postoperatively and patient and observer scar assessment scale

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.