Clinical trial

Dexmedetomidine Ropivacaine Versus Plain Ropivacaine in Bilateral Pectoralis Nerve Block

Name
E-23
Description
Background: Multimodal analgesia for control of postoperative pain in cardiac surgical patients helps in early recovery and ambulation. Pectoral nerve (PECS) block with ropivacaine is novel, less invasive regional analgesic technique with an effect comparable to paravertebral, and thoracic epidural analgesia. Aim: The aim of this study is to assess the effect of dexmedetomidine as an adjuvant to ropivacaine on the quality and efficiency of the ultra-sound guided pectoralis nerve block in patients undergoing open heart surgery through midline sternotomy for fast-track anesthesia and postoperative analgesia.
Trial arms
Trial start
2023-08-01
Estimated PCD
2024-08-10
Trial end
2024-08-20
Status
Recruiting
Treatment
Ropivacaine
dexmedetomidine
Arms:
Group (C), Group (DR), Group (R)
Size
90
Primary endpoint
the total postoperative opioid consumption
the first 48 hours postoperative
Eligibility criteria
Inclusion Criteria: * Age 20 - 65 years, * Ejection fraction (EF) \> 35%, * Elective-isolated CABG, or Valve surgery Exclusion Criteria: * Poor left ventricular function with intra-aortic balloon pump support, * Recent myocardial infarction (last seven days), * Combined procedure (i.e., CABG + other heart/vascular procedure), * Emergency surgery, or Redo cases, * Hepatic or renal failure, creatinine \>1.5, * Patients with hemodynamic instability, preexisting infection at the site of block, allergy to local anesthetics, psychiatric illness, and patients with prolonged postoperative ventilatory course were excluded from the study.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}
Updated at
2023-09-13

1 organization

1 product

1 indication