Clinical trial

Evaluation of the Efficacy of M-TAPA and EXORA Block Application for Analgesia After Laparoscopic Cholecystectomy; Prospective, Single-blind, Observational Study

Name

2023-3/1

Description

Postoperative pain is important for patient comfort, wound healing and earlier mobilisation. Different procedures are used by clinicians for this purpose. Intravenous and regional anaesthesia techniques can be used for this purpose in patients undergoing laparoscopic cholecystectomy.

Trial arms

Trial start

2023-08-25

Estimated PCD

2023-12-25

Trial end

2024-01-13

Status

Not yet recruiting

Treatment

M-TAPA block

ultrasound guided Modified thoracoabdominal nerves block through perichondrial approach(M-TAPA) block (0.3 ml/kg , %0.25 bupivacaine) will be performed

Arms:

Group M

EXORA block

Ultrasound guided External Oblique And Rectus Abdominis Plane (EXORA) Block block (0.3 ml/kg , %0.25 bupivacaine) will be performed

Arms:

Group E

Tramadol

400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; Patient-controlled analgesia settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.

Arms:

Group E, Group M, Group P

Size

Primary endpoint

NRS

Postoperative 24 hours

Eligibility criteria

Inclusion Criteria: * laparoscopic cholecystectomy surgery * Patients with ASA (American Society of Anaesthetists) scores I and III will be included. Exclusion Criteria: * Uncontrolled Arterial Hypertension * Uncontrolled Diabetes Mellitus, * Mental retardation , * Antidepressant use * Metabolic disorders, * Bleeding diathesis * Patients with a body mass index above 30.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective, single-blind, observational study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}

Updated at

2023-08-25

1 organization

1 product

3 indications

Organization

Bursa Yüksek Ihtisas Education and Research Hospital

Product

Indication

Indication

Indication