Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

Comparison of M-TAPA and ESPB for Postoperative Pulmonary Function After Laparoscopic Cholecystectomy

18 czerwca 2026 zaktualizowane przez: Muhammed Nail Tekcan, Kayseri City Hospital

Comparison of the Effects of Erector Spinae Plane Block and Modified Thoracoabdominal Nerve Block Through Perichondrial Approach on Postoperative Pulmonary Function and Analgesic Consumption in Patients Undergoing Laparoscopic Cholecystectomy

This prospective, randomized, controlled clinical trial aims to compare the effects of two ultrasound-guided fascial plane blocks, the Erector Spinae Plane Block (ESPB) and the Modified Thoracoabdominal Nerve Block through Perichondrial Approach (M-TAPA), on postoperative pulmonary function and analgesic consumption in patients undergoing laparoscopic cholecystectomy. Laparoscopic cholecystectomy is one of the most frequently performed abdominal surgical procedures worldwide. Despite minimally invasive techniques, postoperative pain remains a significant clinical problem due to port-site trauma, pneumoperitoneum, diaphragmatic irritation, and visceral manipulation.

Inadequate pain control may lead to impaired respiratory mechanics, reduced mobilization, delayed recovery, and an increased risk of postoperative pulmonary complications. Postoperative pulmonary dysfunction is a common consequence of upper abdominal surgery and may persist for several days, contributing to reductions in forced vital capacity (FVC) and forced expiratory volume in one second (FEV1), which are associated with increased postoperative morbidity.

Although opioid-based analgesia is widely used, it is associated with adverse effects such as respiratory depression, nausea, vomiting, ileus, and delayed recovery. Therefore, regional anesthesia techniques and multimodal analgesia strategies are increasingly recommended to reduce opioid consumption while improving pain control.

ESPB and M-TAPA are ultrasound-guided fascial plane blocks used for postoperative analgesia in abdominal surgery. ESPB provides somatic and visceral analgesia through the spread of local anesthetic affecting the spinal nerve rami, while M-TAPA targets the anterior branches of the thoracoabdominal nerves to provide extensive anterior and lateral abdominal wall analgesia.

Despite their increasing use, there is limited high-quality comparative evidence evaluating the effects of ESPB and M-TAPA on postoperative pulmonary function and opioid consumption in laparoscopic cholecystectomy. This study compares these two regional anesthesia techniques in a randomized controlled design to evaluate their impact on postoperative respiratory function and analgesic requirements.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

This study is a prospective, randomized, controlled clinical trial designed to compare the effects of two ultrasound-guided fascial plane blocks, the Erector Spinae Plane Block (ESPB) and the Modified Thoracoabdominal Nerve Block through Perichondrial Approach (M-TAPA), on postoperative pulmonary function and analgesic consumption in patients undergoing laparoscopic cholecystectomy.

A total of 60 patients will be randomly allocated into two groups: ESPB group (n=30) and M-TAPA group (n=30). All patients will undergo standard general anesthesia. After induction of general anesthesia and before surgical incision, regional blocks will be performed.

Patients in the ESPB group will receive bilateral ultrasound-guided erector spinae plane block at the T9 vertebral level using 0.25% bupivacaine, 20 mL per side (total 40 mL). Patients in the M-TAPA group will receive bilateral ultrasound-guided modified thoracoabdominal nerve block through the perichondrial approach using the same concentration and volume of local anesthetic (0.25% bupivacaine, total 40 mL).

All blocks will be performed under sterile conditions using a high-frequency linear ultrasound probe and an 80 mm echogenic needle.

All patients will receive standardized multimodal analgesia, including intravenous paracetamol (1 g every 8 hours) and intravenous ibuprofen (400 mg every 12 hours) for 24 hours postoperatively. The first doses of paracetamol and ibuprofen will be administered 10 minutes before the end of surgery.

Postoperative pain will be assessed using the Numeric Rating Scale (NRS) at rest and during movement at 1, 6, 12, 18, and 24 hours after surgery. Patient-controlled analgesia (PCA) with morphine will be used for postoperative analgesia. The PCA device will be set to deliver 1 mg morphine boluses with a lockout interval of 15 minutes and a maximum dose of 96 mg within 24 hours. Rescue analgesia with intravenous fentanyl (25 mcg) will be administered in patients with persistent pain (NRS ≥4 despite PCA bolus).

Total opioid consumption will be calculated as cumulative morphine consumption within the first 24 postoperative hours.

Pulmonary function tests will be performed preoperatively and at 1, 6, and 24 hours postoperatively, including forced vital capacity (FVC), forced expiratory volume in one second (FEV1), FEV1/FVC ratio, and peak expiratory flow (PEF).

Postoperative recovery quality will be evaluated using the Quality of Recovery-15 (QoR-15) questionnaire at 24 hours after surgery.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

60

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Muhammed N Tekcan, Anesthesiology and Reanimation
  • Numer telefonu: +905387931833
  • E-mail: mntekcan@gmail.com

Lokalizacje studiów

  • Turcja (Türkiye)
    • Kocasinan
      • Kayseri, Kocasinan, Turcja (Türkiye), 38080
        • Kayseri City Hospital

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

  • Patients aged 18-70 years
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Patients scheduled for elective laparoscopic cholecystectomy
  • Patients who provide written informed consent
  • Patients who are able to cooperate and perform pulmonary function tests (PFTs)

Exclusion Criteria:

  • Coagulation disorders or anticoagulant therapy contraindicating regional anesthesia
  • Infection at the planned block site
  • Known allergy to local anesthetic agents
  • Conversion to open surgery
  • Hemodynamic instability
  • Inability to cooperate with pulmonary function tests (PFTs)
  • Pre-existing severe pulmonary disease (e.g., severe chronic obstructive pulmonary disease or restrictive lung disease)
  • Chronic opioid use or opioid dependence
  • Pregnancy or breastfeeding
  • Active smokers
  • Body mass index (BMI) > 35 kg/m²

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Poczwórny

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: M-TAPA Block
An ultrasound-guided modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA) performed bilaterally with local anesthetic for postoperative analgesia after laparoscopic cholecystectomy.
Procedura: Modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA)
An ultrasound-guided modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA) was performed bilaterally under sterile conditions. The ultrasound transducer was placed in the sagittal plane at the 9th-10th rib level. The probe was angled to visualize the underside of the costal margin. After identification of the target fascial plane, an echogenic needle was advanced in-plane until the tip was positioned beneath the costal cartilage. Hydrodissection with 5 mL of saline was used to confirm correct needle placement. Following confirmation, 20 mL of 0.25% bupivacaine was administered on each side, for a total volume of 40 mL. Blocks were performed under ultrasound guidance using an 80 mm echogenic needle and a 6-10 MHz linear transducer.
Eksperymentalny: Erector spinae plane block (ESPB)
An ultrasound-guided erector spinae plane block (ESPB) performed with local anesthetic for postoperative analgesia after laparoscopic cholecystectomy.
Procedura: Erector spinae plane block (ESPB)
An ultrasound-guided erector spinae plane block (ESPB) was performed bilaterally at the T9 vertebral level under sterile conditions. A high-frequency linear ultrasound probe (6-10 MHz) was used to identify the erector spinae muscle and transverse process. An 80 mm echogenic needle was advanced in-plane in a cranio-caudal direction until the tip was positioned in the fascial plane deep to the erector spinae muscle. Hydrodissection with saline was used to confirm correct needle placement, followed by administration of 20 mL of 0.25% bupivacaine on each side, for a total volume of 40 mL.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Forced Expiratory Volume in 1 Second (FEV1)
Ramy czasowe: Preoperatively (baseline), and at 1, 6, and 24 hours postoperatively.
Forced expiratory volume in one second (FEV1, liters) will be measured to assess postoperative pulmonary function.
Preoperatively (baseline), and at 1, 6, and 24 hours postoperatively.
Forced Vital Capacity (FVC)
Ramy czasowe: Preoperatively (baseline), and at 1, 6, and 24 hours postoperatively.
Forced vital capacity (FVC, liters) will be measured to assess postoperative pulmonary function.
Preoperatively (baseline), and at 1, 6, and 24 hours postoperatively.
FEV1/FVC Ratio
Ramy czasowe: Preoperatively (baseline), and at 1, 6, and 24 hours postoperatively.
The FEV1/FVC ratio (percentage, %) will be measured to assess postoperative pulmonary function.
Preoperatively (baseline), and at 1, 6, and 24 hours postoperatively.
Peak Expiratory Flow (PEF)
Ramy czasowe: Preoperatively (baseline), and at 1, 6, and 24 hours postoperatively.
Peak expiratory flow (PEF, liters/minute) will be measured to assess postoperative pulmonary function.
Preoperatively (baseline), and at 1, 6, and 24 hours postoperatively.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Total Opioid Consumption
Ramy czasowe: First 24 postoperative hours
Total opioid consumption will be calculated as cumulative morphine dose delivered via patient-controlled analgesia (PCA) and rescue analgesic requirements during the first 24 postoperative hours.
First 24 postoperative hours
Postoperative Pain Scores (NRS)
Ramy czasowe: Postoperative 1st, 6th, 12th, 18th, and 24th hours
Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS) at rest (static) and during movement (dynamic). (Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain)
Postoperative 1st, 6th, 12th, 18th, and 24th hours
Quality of Recovery-15 (QoR-15)
Ramy czasowe: 24 hours postoperatively
Postoperative recovery quality will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire. (Scores range from 0 to 150, where 0 indicates the worst possible recovery and 150 indicates the excellent/best possible recovery)
24 hours postoperatively

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Kayseri City Hospital

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 lipca 2026

Zakończenie podstawowe (Szacowany)

1 stycznia 2027

Ukończenie studiów (Szacowany)

1 marca 2027

Daty rejestracji na studia

Pierwszy przesłany

15 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

18 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

24 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

24 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

18 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • MTAPA-ESP-LC-SFT-2026-01

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Opis planu IPD

Anonymized participant-level data, including demographic variables, pulmonary function tests, pain scores, opioid consumption, and QoR-15 outcomes, may be shared upon reasonable request.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Funkcja płuc

Wyszukaj podobne próby

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

CROs by country

CROs in Burundi

Warunki

Rzadkie choroby

Interwencje lekowe

Suplementy diety

Sponsor / Współpracownicy

Lokalizacje

Subskrybuj