Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Coronary (Artery) Disease
  • Pain Acute
  • Pain Postoperative
  • Valve Disease, Heart
Type
Interventional
Phase
Phase 4
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Investigator, Outcomes Assessor)Masking Description: The study subjects will be blinded to the allocated groups. The outcome assessor (the investigator who will assess the primary and secondary outcomes) will be blinded to the allocated groups.Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Pain after cardiac surgery is triggered by numerous factors including skin incision, sternotomy, sternal and rib retraction, internal mammary artery and saphenous vein harvesting, surgical manipulation of pleura, placement of chest tubes and tissue trauma during surgery.Median sternotomy significant...

Pain after cardiac surgery is triggered by numerous factors including skin incision, sternotomy, sternal and rib retraction, internal mammary artery and saphenous vein harvesting, surgical manipulation of pleura, placement of chest tubes and tissue trauma during surgery.Median sternotomy significantly reduces postoperative pulmonary function; however, it is the most commonly used approach because it facilitates exposure of the surgical field. Pain prevents early mobilization, reduction in pulmonary function and accumulation of bronchial secretions resulting in atelectasis, pulmonary infections, hypoxia and increase duration of ICU stay.Prolonged ICU stay is associated with greater risk of respiratory and renal dysfunction, and increases morbidity and mortality. Optimal post-operative pain management allows early weaning from mechanical ventilation and extubation, early mobilization, facilitate beginning of chest physiotherapy, shortens the length of ICU stay and hospitalization, medical costs and decreases incidence of post-operative complications. Opioid infusions and patient-controlled analgesia (PCA) remain the principal and most commonly used for immediate postoperative analgesia after cardiac surgery in Intensive Care Units. Multimodal opioid sparing analgesia has become frequently used. They are used for the opioids sparing effect and for achievement of a more efficient pain management via both central and peripheral anti-nociceptive mechanisms. Dexmedetomidine is an intravenous ?-2 agonist widely used for sedation, anxiolysis and for augmenting anesthesia and analgesia with reduction in opioid requirements. Ketamine have a great analgesic effect and can be added to multimodal regimen. Magnesium can be added to multimodal regimen as it acts as a non-competitive antagonist of N-methyl-D-aspartate (NMDA) receptors and has anti-inflammatory effects and can be used in acute pain management. The aim of this study is to compare between traditional high opioid, low opioid and non-opioid technique on the patient outcome. This prospective randomized comparative study will be conducted on 75 patients undergoing cardiac procedures that will require cardiopulmonary bypass and median sternotomy at Cardiothoracic Surgical Department, Mansoura University Hospitals over 24 months. Eligible 75 patients will be randomly allocated to one of three equal groups each contains 25 patients, they will be randomized according to computer-generated randomization sequence: Either high opioid group (group I), Low opioid group (group II) and non-opioid group (group III).

Tracking Information

NCT #
NCT04223219
Collaborators
Not Provided
Investigators
Not Provided