Clinical trial NCT04223219: Different Modalities of Analgesia in Open Heart Surgeries in Mansoura University
Official title: Different Modalities of Analgesia in Open Heart Surgeries in Mansoura University: Randomized Prospective Comparative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Valve Disease, Heart
Pain, Acute
Pain, Postoperative
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-01-10
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cardiac surgery is associated with post-operative pain which is one of the major problems and remains one of the most controversial issues. Inadequate pain control after cardiac surgery increases the incidence of development of many complications. Intravenous opioids are commonly used for postoperative analgesia either on demand "physician or nurse-controlled" or patient -controlled.

Multimodal opioid sparing analgesia has become frequently used, These techniques can be achieved with Dexmedetomidine, low-dose ketamine and magnesium.

The study hypotheses that control of perioperative quality of pain with opioid sparing medications may improve analgesia and patient outcome.

Detailed 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 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 α-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 90 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).

Eligibility criteria: Inclusion Criteria:

* Adult patients of both gender,
* Aged above 18 years
* American Society of Anesthesiologists (ASA) physical status II \& III,
* Body mass index less than 40 kg/m2
* Scheduled for any cardiac procedure with median sternotomy that require cardiopulmonary bypass at Cardiothoracic Surgical Department, Mansoura University Hospitals.

Exclusion Criteria:

* Patients with pulmonary dysfunction or chronic obstructive pulmonary diseases
* Acute or unstable angina
* Previous cardio-thoracic surgery
* Emergency surgery
* Left ventricular ejection fraction less than 40%
* Dysrhythmia or pacemaker
* Major hepatic or renal dysfunction
* Need for re-exploration, uncontrolled diabetes (HbA1c \> 8.5)
* Neurological deficit
* Hyper-magnesemia

Primary outcomes:
measure: Pain score at rest assessed using the visual analogue scale.
timeFrame: 30 minutes after tracheal extubation
Secondary outcomes:
measure: Pain score at rest assessed using the visual analogue scale.
timeFrame: 2, 6, 12, and 24 hours after tracheal extubation
measure: Sedation level assessed using Ramsay sedation score
timeFrame: 30 minutes, 2, 6, 12, and 24 hours after tracheal extubation
measure: Heart rate
timeFrame: every 15 minutes in the first hour then every 30 minutes intraoperative and then 1 hour post-operative
measure: Systolic blood pressure
timeFrame: every 15 minutes in the first hour then every 30 minutes intraoperative and then 1 hour post-operative
measure: Diastolic blood pressure
timeFrame: every 15 minutes in the first hour then every 30 minutes intraoperative and then 1 hour post-operative
measure: Mean arterial blood pressure
timeFrame: every 15 minutes in the first hour then every 30 minutes intraoperative and then 1 hour post-operative
measure: Total opioid consumption
timeFrame: 24 hours post operative
measure: Time to tracheal extubation
timeFrame: 2 hours to 6 hours
measure: Duration of ICU stay
timeFrame: 2 to 5 days
measure: Time to either bowel movement or flatus
timeFrame: within 24 hours
measure: Number of participants with post-operative nausea and vomiting (PONV)
timeFrame: within 24 hours
measure: Doses of atropine required
timeFrame: from start to the end of surgery
measure: Doses of Inotropic required
timeFrame: from start to the end of surgery
measure: Doses of vasopressors required
timeFrame: from start to the end of surgery
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura Faculty of medicine
Study officials:
References: