Postoperative Pain Alleviation in Open Heart Surgery

Study Overview
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Brief Summary
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Effective pain relief after cardiac surgery has assumed importance with the introduction of fast track discharge protocols that requires early weaning from mechanical ventilation. Inadequate pain control reduces the capacity to cough, mobility, increases the frequency of atelectasis, and prolongs recovery. Infiltration of local anesthetics near the surgical wound has shown to improve early postoperative pain in various surgical procedures. Magnesium is the fourth most plentiful cation in our body. It has antinociceptive effects in animal and human models of pain.

Detailed Description
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Effective pain relief after cardiac surgery has assumed importance with the introduction of fast track discharge protocols that requires early weaning from mechanical ventilation. Inadequate pain control reduces the capacity to cough, mobility, increases the frequency of atelectasis, and prolongs recovery. A major cause of pain after cardiac surgery is the median sternotomy particularly on the first two postoperative days. The most often used analgesics in these patients are parenteral opioids which can lead to undesirable side-effects as sedation, respiratory depression, nausea, and vomiting. Infiltration of local anesthetics near the surgical wound has shown to improve early postoperative pain in various surgical procedures. Magnesium is the fourth most plentiful cation in our body. It has antinociceptive effects in animal and human models of pain. It has been mentioned in a systematic review that it may be worthwhile to further study the role of supplemental magnesium in providing perioperative analgesia, because this is a relatively harmless molecule, is not expensive and also because the biological basis for its potential antinociceptive effect is promising. These effects are primarily based on physiological calcium antagonism, that is voltage-dependent regulation of calcium influx into the cell, and noncompetitive antagonism of N-methyl-D-aspartate (NMDA) receptors. there is a need to evaluate and compare local magnesium with bupivacaine , in comparison to bupivacain ,and other conventional intarvenous analgesics

Official Title
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Postoperative Pain Alleviation in Patients Undergoing Cardiac Surgery; Presternal Bupivacaine and Magnesium Infiltration Versus Conventional Intravenous Analgesia

Conditions
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Open Heart Surgery, Postoperative Pain

Intervention / Treatment
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* Drug: bupivacain with magnesium sulphate
* Drug: Bupivacaine only
* Drug: conventional


Participation Criteria
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Eligibility Criteria
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Criteria: Inclusion Criteria: 18-60 years old American Society of Anesthesiologists physical status II and III Patients scheduled for open heart valve replacement surgery with sternotomy Exclusion Criteria: Emergency surgery Clinically significant kidney or liver disease Patients allergic to local anesthetic Patients with prolonged CPB time (>120 min) Patients required intra-aortic balloon pump

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: pain control in the early postoperative period
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group A<br>( bupivacain 0.125% magnesium sulfate 5%) infusion in the presternum , for 48 hours | Drug: bupivacain with magnesium sulphate<br>* will receive bupivacain 0.125% and magnesium sulphate 5% infusion in the presternum , for 48 hours<br>* Other names: local anesthetic with adjuvant for 48 hours;|
| Active Comparator: group B<br>bupivacaine 0.125% infusion in the presternum , for 48 hours | Drug: Bupivacaine only<br>* will receive bupivacain 0.125% infusion in the presternum , for 48 hours<br>* Other names: local anesthetic;|
| Active Comparator: Group C<br>will be conventional , will receive postoperative fentanyl , paracetamol , and ketorolac. | Drug: conventional<br>* only conventional post operative analgesics will be used<br>* Other names: paracetamol , Ketorolac;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain | Vas Scale | 48 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| extubation time | time to separate patient from mechanical ventilation and extubation | 48 hours | 
| Fentanyl consumption | total fenatnyl consumption | 48 hours |