Pre-incisional Infiltration With Ropivacaine Plus Diprospan for Relieving Postoperative Pain After Laparoscopic Surgery
16 juni 2026 uppdaterad av: Fang Luo, Beijing Tiantan Hospital
The Efficacy and Safety of Pre-incisional Infiltration With Ropivacaine Plus Diprospan in Patients Undergoing Laparoscopic Surgery: a Multi-center Randomized Controlled Trial.
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.
Studieöversikt
Status
Rekrytering
Betingelser
Studietyp
Interventionell
Inskrivning (Beräknad)
150
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Fang Luo
- Telefonnummer: +86 13611326978
- E-post: 13611326978@163.com
Studieorter
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100070
- Rekrytering
- Beijing Tiantan Hospital
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Kontakt:
- Fang Luo
- Telefonnummer: +86 13611326978
- E-post: 13611326978@163.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Nej
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Aktiv komparator: Pre-incisional infiltration with ropivacaine alone
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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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Experimentell: Pre-incisional infiltration with ropivacaine plus diprospan
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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).
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively
Tidsram: The postoperative period 48 hours
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The postoperative period 48 hours
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Numerisk skattningsskala i vila (NRSr) vid 1 vecka, 1 månad och 3 månader postoperativt
Tidsram: Postoperativ dag 7, månad 1 och månad 3.
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Numeric Rating Scale (NRS) anger 0 som ingen smärta och 10 som den mest svåra smärtan; poäng på 1-3 indikerar mild smärta, 4-6 betecknar måttlig smärta och 7-10 betyder svår smärta.
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Postoperativ dag 7, månad 1 och månad 3.
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Adverse events
Tidsram: Within 72 hours postoperatively
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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.
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Within 72 hours postoperatively
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Area under the curve (AUC) of the Numerical Rating Scale during movement (NRSm) within 0-72 hours postoperatively
Tidsram: Data will be collected at 4、12、24、36 and 72 hours postoperatively
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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.
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Data will be collected at 4、12、24、36 and 72 hours postoperatively
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Patient Satisfaction Scale(PSS)
Tidsram: Postoperative hours 4、12、24 and 48 hours
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Patient Satisfaction Scale(PSS) on a scale ranging from 0 to 10, where 0 denotes "completely dissatisfied" and 10 signifies "extremely satisfied".
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Postoperative hours 4、12、24 and 48 hours
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Postoperative nausea and vomiting (PONV)
Tidsram: Postoperatively within 48 hours
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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.
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Postoperatively within 48 hours
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Wound healing score
Tidsram: Postoperative 72 hours、1 and 3 months
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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.
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Postoperative 72 hours、1 and 3 months
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Postoperatively and patient and observer scar assessment scale
Tidsram: Postoperative 72 hours、1 and 3 months
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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.
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Postoperative 72 hours、1 and 3 months
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Area Under the Curve (AUC) of Numeric Rating Scale at rest (NRSr) Within 0-72 Hours Postoperatively
Tidsram: Data will be collected at 4、12、24、36 and 72 hours postoperatively
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Description: scores of 1-3 indicate mild pain, 4-6 denote moderate pain, and 7-10 signify severe pain
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Data will be collected at 4、12、24、36 and 72 hours postoperatively
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Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
30 maj 2026
Primärt slutförande (Beräknad)
30 maj 2027
Avslutad studie (Beräknad)
30 maj 2028
Studieregistreringsdatum
Först inskickad
21 maj 2026
Först inskickad som uppfyllde QC-kriterierna
2 juni 2026
Första postat (Faktisk)
4 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
16 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- KY2025-338-02-5
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JA
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