Laparoscopic-Assisted TAP Block VErsus Trocar-site Infiltration After Laparoscopic Appendectomy
Comparison of Laparoscopic-Assisted Transversus Abdominis Plane Block and Trocar-Site Local Anesthetic Infiltration After Laparoscopic Appendectomy: A Randomized Controlled Trial
This randomized controlled trial compared laparoscopic-assisted transversus abdominis plane (TAP) block with trocar-site local anesthetic infiltration for postoperative pain management in adult patients undergoing laparoscopic appendectomy for uncomplicated acute appendicitis. Sixty patients were randomized to receive either bilateral laparoscopic-assisted TAP block or local anesthetic infiltration at the trocar sites. Postoperative pain intensity, rescue analgesic requirements, recovery parameters, postoperative nausea and vomiting, complications, and length of hospital stay were evaluated.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Istanbul
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Istanbul, Istanbul, Tyrkiet (Türkiye)
- Fatih Sultan Mehmet Training and Reserch Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Age 18-65 years
- ASA physical status I-II
- Uncomplicated acute appendicitis without perforation or phlegmon
- Undergoing laparoscopic appendectomy
- Written informed consent
Exclusion Criteria:
- Allergy to local anesthetics
- Systemic disease such as diabetes mellitus, chronic kidney failure, or bleeding diathesis
- Infection at the block application site
- Regular analgesic use for chronic pain
- Alcohol or narcotic dependence
- Intraoperative diagnosis of perforated or phlegmonous appendicitis
- Conversion from laparoscopic to open surgery
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: laparoscopic-assisted TAP Block
Participants received a bilateral laparoscopic-assisted transversus abdominis plane (TAP) block after induction of general anesthesia. Under direct laparoscopic visualization, 15 mL of 0.25% bupivacaine was administered on each side, for a total volume of 30 mL and a total bupivacaine dose of 75 mg. |
Bilateral laparoscopic-assisted transversus abdominis plane (TAP) block was performed after induction of general anesthesia. Under direct laparoscopic visualization, 15 mL of 0.25% bupivacaine was administered on each side, for a total volume of 30 mL and a total bupivacaine dose of 75 mg. |
|
Aktiv komparator: trocar-site local anesthetic infiltration
Participants received local anesthetic infiltration at the three trocar sites before skin incision. A total of 15 mL of 0.5% bupivacaine was administered, with 5 mL infiltrated at each trocar site into the skin, subcutaneous tissue, and fascia, for a total bupivacaine dose of 75 mg. |
Local anesthetic infiltration was performed at the three trocar sites before skin incision. A total of 15 mL of 0.5% bupivacaine was administered, with 5 mL infiltrated at each trocar site into the skin, subcutaneous tissue, and fascia, for a total bupivacaine dose of 75 mg. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Postoperative Pain Intensity Assessed by Visual Analog Scale (VAS)
Tidsramme: Postoperative hours 0, 2, 6, 12, and 24
|
Postoperative pain at rest was assessed using the Visual Analog Scale (VAS) in both study groups at predefined postoperative time points. |
Postoperative hours 0, 2, 6, 12, and 24
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Smerte
- Neurologiske manifestationer
- Postoperative komplikationer
- Patologiske processer
- Tarmsygdomme
- Infektioner
- Sygdomme i fordøjelsessystemet
- Gastrointestinale sygdomme
- Gastroenteritis
- Cecale sygdomme
- Intraabdominale infektioner
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- Smerter, postoperativ
- Blindtarmsbetændelse
Andre undersøgelses-id-numre
- FSMEAH-TAP-207-26
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
De-identified individual participant data underlying the results reported in this study and related analysis outputs will be available from the corresponding author upon reasonable request.
IPD-delingstidsramme
Data will be available upon reasonable request following publication of the study results.
IPD-delingsadgangskriterier
De-identified individual participant data and related analysis outputs will be available to researchers upon reasonable request to the corresponding author.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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