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- Essai clinique NCT07619053
Transversalis Fascia Plane Block Versus M-TAPA Block After Laparoscopic Inguinal Hernia Repair
Transversalis Fascia Plane Block Versus Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) for Postoperative Analgesia After Laparoscopic Inguinal Hernia Repair: A Prospective Randomized Controlled Trial
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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 Transversalis Fascia Plane Block (TFPB) and M-TAPA Block on Visual Analog Scale (VAS) scores in patients undergoing laparoscopic inguinal hernia repair. 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, 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Patients who meet the exclusion criteria will be withdrawn from the study.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 TFP Group TFP will receive a bilateral Transversalis Fascia Plane Block. Group M-TAPA 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.
Transversalis Fascia Plane Block (TFPB) The block will be performed 30 minutes prior to surgery with the patient in the 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 high-frequency linear ultrasound probe (Mindray Diagnostic Ultrasound System, Model DC-T6) will be positioned transversely above the iliac crest along the midaxillary line.
Anatomical landmarks, including the external oblique muscle, internal oblique muscle, transversus abdominis muscle, and transversalis fascia will be identified. Using an in-plane approach, a 21 G 0.8×100 mm echogenic insulated needle (Echoplex®+, Vygon SA, Écouen, France) will be advanced through the muscular layers toward the plane between the transversus abdominis muscle and the transversalis fascia.
Proper needle placement will be confirmed with the injection of 1-2 mL isotonic saline demonstrating hydrodissection within the transversalis fascia 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-point Likert scale, where 1 = not satisfied and 5 = very satisfied, based on verbal feedback from both the patient and the surgeon. Nausea and Vomiting: Nausea and vomiting will be scored using a 4-point scale: 0 = none
- = mild
- = moderate
- = severe Potential Complications 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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: ENES ESKİN, CONSULTANT İN ANESTHESİOLOGY
- Numéro de téléphone: +905454738489
- E-mail: eneskin@hotmail.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Patients aged 18-65 years
- ASA physical status I-III
- Scheduled for elective laparoscopic inguinal hernia repair
- 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: TRANSVERSALİS FASCİA PLANE BLOCK
|
A high-frequency linear ultrasound probe will be positioned transversely above the iliac crest along the midaxillary line.Anatomical landmarks, including the external oblique muscle, internal oblique muscle, transversus abdominis muscle, and transversalis fascia will be identified.
Using an in-plane approach, a 21 G 0.8×100 mm echogenic insulated needle will be advanced through the muscular layers toward the plane between the transversus abdominis muscle and the transversalis fascia.Proper needle placement will be confirmed with the injection of 1-2 mL isotonic saline demonstrating hydrodissection within the transversalis fascia plane.
Upon confirmation and negative aspiration, 20 mL of 0.25% bupivacaine hydrochloride will be administered on each side under ultrasound guidance.
|
|
Comparateur actif: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Postoperative pain intensity (VAS score)
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Nécessité d'une analgésie de secours
Délai: Dans les premières 24 heures postopératoires
|
Dans les premières 24 heures postopératoires
|
|
|
Incidence des nausées et vomissements postopératoires
Délai: Dans les 24 premières heures postopératoires
|
Dans les 24 premières heures postopératoires
|
|
|
Consommation totale d'opioïdes via l'analgésie contrôlée par le patient (PCA)
Délai: Dans les 24 premières heures postopératoires
|
Dans les 24 premières heures postopératoires
|
|
|
Quality of recovery assessed using the QoR-15 questionnaire
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
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Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- TFPB vs M-TAPA/İNG.HERNİA
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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