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

2. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

150

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiekontakt

Deltagelseskriterier

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Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

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Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Pre-incisional infiltration with ropivacaine alone
Medicin: 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).
Eksperimentel: Pre-incisional infiltration with ropivacaine plus diprospan
Medicin: 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).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively
Tidsramme: The postoperative period 48 hours
The postoperative period 48 hours

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Numerisk vurderingsskala i hvile (NRSr) 1 uge, 1 måned og 3 måneder postoperativt
Tidsramme: Postoperativ dag 7, måned 1 og måned 3.
Den Numeriske Vurderingsskala (NRS) angiver 0 som ingen smerter og 10 som de mest intense smerter; scores på 1-3 indikerer milde smerter, 4-6 betegner moderate smerter, og 7-10 betyder svære smerter.
Postoperativ dag 7, måned 1 og måned 3.
Adverse events
Tidsramme: 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.
Within 72 hours postoperatively
Area under the curve (AUC) of the Numerical Rating Scale during movement (NRSm) within 0-72 hours postoperatively
Tidsramme: 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.
Data will be collected at 4、12、24、36 and 72 hours postoperatively
Patient Satisfaction Scale(PSS)
Tidsramme: 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 hours 4、12、24 and 48 hours
Postoperative nausea and vomiting (PONV)
Tidsramme: Postoperatively within 48 hours
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.
Postoperatively within 48 hours
Wound healing score
Tidsramme: Postoperative 72 hours、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.
Postoperative 72 hours、1 and 3 months
Postoperatively and patient and observer scar assessment scale
Tidsramme: 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.
Postoperative 72 hours、1 and 3 months
Area Under the Curve (AUC) of Numeric Rating Scale at rest (NRSr) Within 0-72 Hours Postoperatively
Tidsramme: Data will be collected at 4、12、24、36 and 72 hours postoperatively
Description: 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

Samarbejdspartnere og efterforskere

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Sponsor

Beijing Tiantan Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

30. maj 2026

Primær færdiggørelse (Anslået)

30. maj 2027

Studieafslutning (Anslået)

30. maj 2028

Datoer for studieregistrering

Først indsendt

21. maj 2026

Først indsendt, der opfyldte QC-kriterier

2. juni 2026

Først opslået (Faktiske)

4. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KY2025-338-02-5

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