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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-incisional infiltration with ropivacaine plus triamcinolone | Experimental |
| |
| Pre-incisional infiltration with ropivacaine alone | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively | The postoperative period 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve (AUC) of Numeric Rating Scale at rest (NRSr) Within 0-72 Hours Postoperatively | scores of 1-3 indicate mild pain, 4-6 denote moderate pain, and 7-10 signify severe pain | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fang Luo | Contact | +86 13611326978 | 13611326978@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Recruiting | Beijing | Beijing Municipality | 100070 | China |
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| 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). |
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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. |
| 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. | 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. | Postoperative hours 4、12、24 and 48 hours |
| Postoperative nausea and vomiting(PONV) | 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. | Postoperative 72hours、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. | 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. | Postoperative 72 hours、1 and 3 months |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D014221 | Triamcinolone |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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