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Subcostal Transversus Abdominis Plane Block

17 maggio 2026 aggiornato da: Atakan Ozkan, Esencan Hospital

Is the Application of Subcostal Transversus Abdominis Plane Block Effective for Pain Control in Classical Four-Port Laparoscopic Cholecystectomy?

This non-randomized controlled study evaluated the efficacy of a right-sided unilateral Transversus Abdominis Plane (TAP) block for postoperative pain management in 60 adult patients undergoing elective laparoscopic cholecystectomy. Participants were equally divided into a control group receiving standard care and an intervention group that received an ultrasound-guided TAP block using 0.25% bupivacaine prior to extubation. While all patients received scheduled paracetamol and dexketoprofen, tramadol was administered as a rescue analgesic for resting pain scores of 5 or higher. The study's primary goal was to compare postoperative pain using the Verbal Numerical Rating Scale (VNRS) at 0, 6, 12, and 24 hours, with secondary outcomes tracking total rescue tramadol consumption, surgical variables, and postoperative complications to determine the TAP block's overall clinical benefit.

Panoramica dello studio

Stato

Completato

Intervento / Trattamento

Descrizione dettagliata

This non-randomised controlled study was conducted from May 2023 to July 2023 after receiving approval from the Institutional Ethical Review Board. The study protocol adhered to the ethical guidelines of the Declaration of Helsinki. Prior to surgery, written informed consent was obtained from all participants. The inclusion criteria for this study were as follows: individuals aged 18 years or older, scheduled for elective laparoscopic cholecystectomy to treat cholelithiasis, American Society of Anesthesiologists (ASA) physical status of I or II, with no communication barriers, able to cooperate during the intervention, and understanding the use of relevant assessment scales. The exclusion criteria encompassed the following: individuals with contraindications to nerve block, such as infection at the puncture site; those diagnosed with malignancy; individuals suffering from severe liver and kidney diseases, coagulation dysfunction, or similar conditions; individuals with a history of previous abdominal surgery or trauma; long-term users of sedative and analgesic drugs, or those with addiction to alcohol, sedatives, or analgesics; individuals experiencing chronic pain; those with known allergies to the drugs used in the study; individuals with mental illnesses that interfere with perception and pain assessment; individuals taking analgesics prior to surgery; individuals with a body mass index (BMI) ≥ 35; patients who were converted from laparoscopic surgery to open surgery; perforation of the gallbladder during cholecystectomy; women who are pregnant or breastfeeding, and patients who withdrew their consent at any stage of the study.

According to the results of the study performed by Ozciftci et al. (13) and using the the calculator at https://www.istatistikakademisi.com/sayfa/nicel-verilerde-orneklem-buyuklugu-hesabi.html, the standard effect size was determined as 0.78 with a 5% margin of error and 80% power, and it was deemed sufficient to include n = 26 cases in each group, and for this reason, 30 patients in each group, a total of 60 patients, were included in the study. The patients were equally divided into two groups in order to their administration to the hospital one by one. The control group (Group 1, n=30) consisted of patients who did not receive a TAP block, while Group 2 (n=30) comprised patients who underwent a right-sided unilateral TAP block. One patient who had malignant gallbladder pathology after LC and fou patients who gave missing data or who didn't want to participate in the study excluded during the study and five new patients enrolled.

Throughout the procedure, the study adhered to the established institutional protocol for anesthesia induction, monitoring, and maintenance. All patients underwent a standardized anesthesia induction process (using 2-3 mg/kg of propofol, 0.6-1.2 mg/kg of rocuronium, and 1 μg/kg of fentanyl). Following orotracheal intubation, patients were adjusted to maintain a tidal volume of 8 mL/kg, an Inspiration: Expiration ratio of 1:2, a respiratory rate of 12/min, and an end tidal CO2 level ranging from 30 to 40 mmHg in controlled ventilation mode. Anesthesia Throughout the procedure, the study adhered to the established institutional protocol for anesthesia induction, monitoring, and maintenance. All patients underwent a standardized anesthesia induction process (using 2-3 mg/kg of propofol, 0.6-1.2 mg/kg of rocuronium, and 1 μg/kg of fentanyl). Following orotracheal intubation, patients were adjusted to maintain a tidal volume of 8 mL/kg, an Inspiration: Expiration ratio of 1:2, a respiratory rate of 12/min, and an end-tidal CO2 level ranging from 30 to 40 mmHg in controlled ventilation mode. Anesthesia maintenance was achieved through a mixture of 60% oxygen and 40% air, along with sevoflurane (maintaining a minimum alveolar concentration of 2.5-3.0).

All surgical procedures were performed by two experienced senior surgeons. The surgeries followed a consistent approach. A 10mm incision was made in the midline, 2 cm below the xiphoid, and a 10mm periumbilical incision was made parallel to the pelvis. Two additional 5mm right subcostal incisions were performed for trocar insertion during laparoscopic cholecystectomy. All surgical procedures were conducted using a laparoscopic approach, and the abdomen was insufflated with CO2, with the insufflation pressure limited to 13 mmHg throughout the procedure. If a drain was used during the surgery, it was taken out of the abdomen through the 5mm trocar.

The TAP block was performed during the post-anesthesia phase before extubation. The procedure involved the use of an ultrasound system and a linear ultrasound transducer (6-12 Hz). To perform the TAP block, the linear probe was positioned 2 cm below the xiphoid to locate the rectus abdominis muscle and fascia. Moving the probe in a downward and lateral direction, the external oblique, internal oblique, and transversus abdominis muscles and fascia were identified over the oblique subcostal angle. A 1-2 ml dose of 2% lidocaine was then applied at the insertion site of the peripheral block needle. With the probe in the oblique subcostal position, the peripheral block needle (Braun, Ultra360, 100 mm, Germany) was carefully advanced along the fascia of the transversus abdominis and internal oblique muscles, from the medial to the inferolateral area of the probe. The accuracy of the block area was confirmed by infiltrating 1-2 ml of 0.9% isotonic sodium chloride, resulting in a hypoechoic and biconvex appearance, as described in the research conducted by Lee et al. (14), and 20 ml of 0.25% bupivacaine on the right side of the abdomen, following the administration described in Sahin et al.'s study (15).

Intravenous infusion of Paracetamol 1 g (Perfalgan®, Bristol-Myers Squibb, USA) was given to all patients at three time points: immediately after surgery, at the 6th hour, and at the 18th hour after surgery. Additionally, all patients received routine intravenous administration of dexketoprofen 50 mg (Arveles®, Menarini, Italy), immediately after surgery and at the 12th hour after surgery to manage pain. Verbal Numerical Rating Scale (VNRS) was administered to all volunteers for pain assessment as primary outcome at postoperative 0, 6, 12, and 24 hours, where scores between 0 and 10 could be assigned. If a patient reported a VNRS score of 5 or higher while at rest, they were given Tramadol hydrochloride (Contramal®, Grünenthal, Germany) at a dose of 0.5 mg/kg. The total amount of tramadol consumed after surgery, as well as age, gender, BMI, operation time, the use of a drain, and postoperative complications, were recorded for each patient as scondary outcome.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Istanbul, Turchia (Türkiye), 34098
        • Istanbul Training and Research Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Popolazione di studio

Patients who have cholelithiasis

Descrizione

Inclusion Criteria:

  • individuals aged 18 years or older, scheduled for elective laparoscopic cholecystectomy to treat cholelithiasis, American Society of Anesthesiologists (ASA) physical status of I or II, with no communication barriers, able to cooperate during the intervention, and understanding the use of relevant assessment scales

Exclusion Criteria:

  • individuals with contraindications to nerve block, such as infection at the puncture site; those diagnosed with malignancy; individuals suffering from severe liver and kidney diseases, coagulation dysfunction, or similar conditions; individuals with a history of previous abdominal surgery or trauma; long-term users of sedative and analgesic drugs, or those with addiction to alcohol, sedatives, or analgesics; individuals experiencing chronic pain; those with known allergies to the drugs used in the study; individuals with mental illnesses that interfere with perception and pain assessment; individuals taking analgesics prior to surgery; individuals with a body mass index (BMI) ≥ 35; patients who were converted from laparoscopic surgery to open surgery; perforation of the gallbladder during cholecystectomy; women who are pregnant or breastfeeding, and patients who withdrew their consent at any stage of the study.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: TAP Block Group
Patients with TAP block
The TAP block was performed during the post-anesthesia phase before extubation. The procedure involved the use of an ultrasound system and a linear ultrasound transducer. To perform the TAP block, the linear probe was positioned 2 cm below the xiphoid to locate the rectus abdominis muscle and fascia. Moving the probe in a downward and lateral direction, the external oblique, internal oblique, and transversus abdominis muscles and fascia were identified over the oblique subcostal angle. A 1-2 ml dose of 2% lidocaine was then applied at the insertion site of the peripheral block needle. With the probe in the oblique subcostal position, the peripheral block needle was carefully advanced along the fascia of the transversus abdominis and internal oblique muscles, from the medial to the inferolateral area of the probe.
Nessun intervento: Control Group
Patients without TAP block

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pain scale measurements
Lasso di tempo: 24 hours
Verbal Numerical Rating Scale (from 0-10) for pain
24 hours

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Pubblicazioni e link utili

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Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

15 maggio 2023

Completamento primario (Effettivo)

15 luglio 2023

Completamento dello studio (Effettivo)

15 agosto 2023

Date di iscrizione allo studio

Primo inviato

1 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

1 maggio 2026

Primo Inserito (Effettivo)

8 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

20 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

17 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • TAP Block

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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