- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07599787
Intertransverse Process Block Versus M-TAPA Block After Laparoscopic Hysterectomy
15 maggio 2026 aggiornato da: Beste Mutlu Dağlıoğlu, Antalya City Hospital
Intertransverse Process Block Versus M-TAPA Block After Laparoscopic Hysterectomy: A Prospective Randomized Controlled Trial
This randomized clinical trial aims to evaluate and compare the analgesicefficacy of the Intertransverse Process Block (ITPB) and the Modified Thoracoabdominal Nerve Block through Perichondrial Approach (M-TAPA) in patients undergoing laparoscopic hysterectomy.
The primary outcome is the Visual Analog Scale (VAS) score within the first 24 hours after surgery.
Secondary outcomes include total opioid consumption, requirement for rescue analgesia, block- related complications and adverse effects (hematoma, pneumothorax, local anesthetic systemic complications, vascular puncture, and infection), patient satisfaction assessed using a Likert scale, quality of recovery assessed using the QoR-15 questionnaire, and incidence of postoperative nausea and vomiting.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Study Objective: This research aims to obtain objective data to demonstrate the effectiveness of two regional block techniques in acute pain management.
The primary objective is to compare the effects of Intertransverse Process Block (ITPB) and M-TAPA Block on Visual Analog Scale (VAS) scores in patients undergoing laparoscopic hysterectomy.
Secondary outcomes include evaluating the impact of these blocks on total opioid consumption within the first 24 hours, requirement for rescue analgesia, block-related and systemic complications (hematoma, pneumothorax, local anesthetic systemic toxicity, vascular puncture, infection), patient satisfaction assessed using a Likert scale, quality of recovery assessed using the QoR-15 questionnaire, and incidence of postoperative nausea and vomiting.Materials and Methods: This prospective, randomized clinical study will include voluntary patients aged 18-65 years, classified as American Society of Anesthesiologists (ASA) physical status I-III, with a body mass index (BMI) 18-35 kg/m².
All participants will be informed about the study protocol in detail, and written informed consent will be obtained prior to inclusion.
Patients will receive instruction on the use of the VAS for pain assessment, where 0 denotes no pain and 10 denotes the worst imaginable pain.
Patients who meet the exclusion criteria will be withdrawn from the study.
Participants will be randomly assigned to one of two groups using a computer-generated simple randomization method (https://www.randomizer.org).
Randomization will be performed by a team member uninvolved in patient care, who will also prepare sealed opaque envelopes to conceal group allocation until shortly before block administration.Study Groups and Block Procedures: Group ITP will receive a bilateral ITP block, and Group M-TAPA will receive a bilateral M-TAPA block.
All patients will be monitored with electrocardiography, peripheral oxygen saturation (SpO2), and non-invasive blood pressure prior to the block.
Premedication with intravenous midazolam (0.02 mg/kg) will be administered.ITP Block :Intertransverse Process Block (ITP) will be performed 30 minutes prior to surgery with the patient in a sitting position.
After skin disinfection with chlorhexidine, the skin and subcutaneous tissues will be anesthetized using 2-4 mL of 1% lidocaine (Aritmal®, Osel Pharmaceuticals, Turkey).
A linear ultrasound probe (Mindray Diagnostic Ultrasound System, Model DC-T6) will be positioned along the medial border of spinous processes level of the T10 thoracic vertebrae.Anatomical landmarks, including the erector spinae muscle, transverse processes, and superior costotransverse ligament complex at the T10 level, will be identified.
Using an in-plane approach, a 21 G 0.8x100 mm echogenic insulated needle (Echoplex®+ , Vygon SA, Écouen, France) will be inserted through the erector spinae muscle toward the intertransverse tissue complex located between the superior costotransverse ligament and the transverse processes.
Proper needle placement will be confirmed with the injection of 1-2 mL isotonic saline demonstrating separation within the intertransverse plane.
Upon confirmation and negative aspiration, 20 mL of 0.25% bupivacaine hydrochloride (Buvasin®, Vem Pharmaceuticals, Turkey) will be administered on each side under ultrasound guidance.M-TAPA Block:The Block will be performed 30 minutes prior to surgery with the patient in a supine position.
After skin disinfection with chlorhexidine, the skin and subcutaneous tissues will be anesthetized using 2-4 mL of 1% lidocaine (Aritmal®, Osel Pharmaceuticals, Turkey).
A linear ultrasound probe (Mindray Diagnostic Ultrasound System, Model DC-T6) will be positioned obliquely along the costal margin at the level of the 10th costal cartilage.Anatomical landmarks, including the costal cartilage, rectus abdominis muscle, transversus abdominis muscle, and internal oblique muscle will be identified.
Using an in-plane approach, a 21G 0.8×100 mm echogenic insulated needle (Echoplex®+ , Vygon SA, Écouen, France) will be inserted toward the perichondrial plane beneath the 10th costal cartilage under ultrasound guidance.
Proper needle placement will be confirmed with the injection of 1-2 mL isotonic saline.
Upon confirmation and negative aspiration, 20 mL of 0.25% bupivacaine hydrochloride (Buvasin®, Vem Pharmaceuticals, Turkey) will be administered on each side under ultrasound guidance.General Anesthesia Upon entry into the operating room, patients will be monitored with electrocardiography, peripheral oxygen saturation (SpO#), and non-invasive blood pressure.
Anesthesia will be induced with intravenous propofol (2 mg/kg, Polifarma Pharmaceutical Industry and Trade Inc., Ergene, Turkey), fentanyl citrate (1.5 mcg/kg, Polifarma Pharmaceutical Industry and Trade Inc., Ergene, Turkey), and rocuronium bromide (0.6 mg/kg, Muscuron®, Koçak Farma Pharmaceutical and Chemical Industry Co., Turkey).
Anesthesia maintenance will be provided using 6% desflurane in a 40%oxygen-air mixture and a continuous remifentanil infusion at 0.05 mcg/kg/min.
Mechanical ventilation settings will be adjusted to deliver a tidal volume of 6-8 mL/kg with end-tidal CO# maintained at 30-35 mmHg.
Anesthetic depth will be monitored continuously using a Bispectral Index (BIS™) monitor (Medtronic plc, Dublin, Ireland), targeting a BIS value of 40-60.
If heart rate or mean arterial pressure increases >20% from baseline, the remifentanil dose will be titrated accordingly.Thirty minutes before the end of surgery, all patients will receive 15 mg/kg of intravenous paracetamol (e.g., Paracerol®, Polifarma Pharmaceutical Industry and Trade Inc., Ergene, Turkey) and 1 mg/kg of intravenous tramadol.
To prevent nausea and vomiting, 4 mg intravenous ondansetron will be administered.
Patients with adequate spontaneous ventilation will be extubated and transferred to the post-anesthesia care unit (PACU).
Hemodynamic Monitoring Heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, and oxygen saturation will be recorded at the following time points: pre-induction (baseline), 5 minutes after induction, 5 minutes after surgical incision, 15 minutes after incision, and at the end of surgery.Postoperative Pain and Analgesic Use: Pain will be assessed using the VAS at rest (static) and during movement (dynamic) at 0, 1, 4, 8, 12, and 24 hours postoperatively.All patients will use patient-controlled analgesia (PCA) without a basal infusion.
The PCA device will be set to deliver 1 mg of morphine (0.2 mg/mL concentration) with a 10-minute lockout interval.
Patients will be instructed to press the PCA button when VAS ≥4.
Intravenous paracetamol will be administered every 8 hours.
Rescue analgesia with intravenous tramadol (1 mg/kg) will be provided if VAS scores remain ≥4.
The total amounts of opioids, NSAIDs, and other analgesics will be recorded.Postoperative Recovery Quality Postoperative recovery will be assessed using the 15-item Quality of Recovery-15 (QoR-15) questionnaire, which evaluates five domains: pain, physical comfort, physical independence, psychological support, and emotional state.Patient Satisfaction Satisfaction will be evaluated using a 5-pointLikert scale, where 1 = not satisfied and 5 = very satisfied, based on verbalfeedback from both the patient and the surgeon.Nausea and Vomiting: Nausea and vomiting will be scored using a 4-point scale:0 = none1.
= mild2.
= moderate3.
= severe Potential Complications Any complications associated withthe block or the surgical procedure (e.g., hematoma, pneumothorax,local anesthetic systemic toxicity, vascular puncture, or infection) will berecorded.
Tipo di studio
Interventistico
Iscrizione (Stimato)
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.
Contatto studio
- Nome: Beste Mutlu Dağlıoğlu
- Numero di telefono: +905546892608
- Email: drbeste.bm@gmail.com
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
Descrizione
Inclusion Criteria:
- Patients aged 18-65 years
- ASA physical status I-III
- Scheduled for elective laparoscopic hysterectomy
- Body mass index (BMI) 18-35 kg/m²
- Ability to understand and use the patient-controlled analgesia (PCA) device
- Ability to provide written informed consent
Exclusion Criteria:
- Refusal to participate
- Allergy to local anesthetics
- Infection at the injection site
- Coagulopathy or ongoing anticoagulant therapy
- Chronic opioid use or opioid dependence
- Severe hepatic or renal insufficiency
- Pregnancy or breastfeeding
- Cognitive impairment or inability to communicate pain scores
- Body mass index (BMI) >35 kg/m²
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: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Blocco Intertrasversale dei Processi
|
A linear ultrasound probe will be positioned along the medial border of spinous processes level of the T10 thoracic vertebrae.Anatomical landmarks, including the erector spinae muscle, transverse processes, and superior costotransverse ligament complex at the T10 level, will be identified.
Using an in-plane approach, a 21 G 0.8x100 mm echogenic insulated needle will be inserted through the erector spinae muscle toward the intertransverse tissue complex located between the superior costotransverse ligament and the transverse processes.
Proper needle placement will be confirmed with the injection of 1-2 mmL isotonic saline demonstrating separation within the intertransverse plane.
Upon confirmation and negative aspiration, 20 mL of 0.25% bupivacaine hydrochloride will be administered on each side under ultrasound guidance.
|
|
Comparatore attivo: M-TAPA Block
|
A linear ultrasound probe will be positioned obliquely along the costal margin at the level of the 10th costal cartilage.
Anatomical landmarks, including the costal cartilage, rectus abdominis muscle, transversus abdominis muscle, and internal oblique muscle will be identified.
Using an in-plane approach, a 21G 0.8×100 mm echogenic insulated needle will be inserted toward the perichondrial plane beneath the 10th costal cartilage under ultrasound guidance.
Proper needle placement will be confirmed with the injection of 1-2 mL isotonic saline.
Upon confirmation and negative aspiration, 20 mL of 0.25% bupivacaine hydrochloride will be administered on each side under ultrasound guidance.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Postoperative pain intensity (VAS score)
Lasso di tempo: 0, 1, 4, 8, 12, and 24 hours after surgery
|
Postoperative pain will be assessed using the visual analog scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores represent greater pain intensity.
|
0, 1, 4, 8, 12, and 24 hours after surgery
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Requisito per l'analgesia di soccorso
Lasso di tempo: Nelle prime 24 ore postoperatorie
|
Nelle prime 24 ore postoperatorie
|
|
|
Incidenza di nausea e vomito postoperatori
Lasso di tempo: Nelle prime 24 ore postoperatorie
|
Nelle prime 24 ore postoperatorie
|
|
|
Consumo totale di oppioidi tramite analgesia controllata dal paziente (PCA)
Lasso di tempo: Nelle prime 24 ore postoperatorie
|
Nelle prime 24 ore postoperatorie
|
|
|
Quality of recovery assessed using the QoR-15 questionnaire
Lasso di tempo: At 24 hours postoperatively
|
Quality of recovery will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire, which ranges from 0 to 150, with higher scores indicating better recovery.
|
At 24 hours postoperatively
|
|
Potential Complications
Lasso di tempo: Within the first 24 hours postoperatively
|
Any complications associated with the block or the surgical procedure (e.g., hematoma, pneumothorax, local anesthetic systemic toxicity, vascular puncture, or infection) will be recorded.
|
Within the first 24 hours postoperatively
|
|
Patient satisfaction
Lasso di tempo: At 24 hours postoperatively
|
Patient satisfaction will be assessed using Likert scala (1 =very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, 5 = very satisfied).
Higher scores indicate greater satisfaction.
|
At 24 hours postoperatively
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
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 (Stimato)
18 novembre 2026
Completamento primario (Stimato)
30 settembre 2027
Completamento dello studio (Stimato)
30 novembre 2027
Date di iscrizione allo studio
Primo inviato
15 maggio 2026
Primo inviato che soddisfa i criteri di controllo qualità
15 maggio 2026
Primo Inserito (Effettivo)
20 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
20 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
15 maggio 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- ITPvsMTAPA-LH
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
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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