- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07666646
Comparison of M-TAPA and ESPB for Postoperative Pulmonary Function After Laparoscopic Cholecystectomy
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.
Panoramica dello studio
Stato
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Muhammed N Tekcan, Anesthesiology and Reanimation
- Numero di telefono: +905387931833
- Email: mntekcan@gmail.com
Luoghi di studio
-
-
Kocasinan
-
Kayseri, Kocasinan, Turchia (Türkiye), 38080
- Kayseri City Hospital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
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.
|
|
Sperimentale: Erector spinae plane block (ESPB)
An ultrasound-guided erector spinae plane block (ESPB) performed with local anesthetic for postoperative analgesia after laparoscopic cholecystectomy.
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Total Opioid Consumption
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- MTAPA-ESP-LC-SFT-2026-01
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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 .
Prove cliniche su Funzione polmonare
-
Paul SzabolcsReclutamentoMalattia granulomatosa cronica | Sindrome di DiGeorge | Disregolazione immunitaria | Immunodeficienza variabile comune (CVID) | Sindrome di Omen | Carenza di ligando CD40 | Suscettibilità mendeliana alla malattia micobatterica | Disturbo primario della regolazione immunitaria | STAT 1 Gain of Function | STAT... e altre condizioniStati Uniti