Postoperative Pain Alleviation in Open Heart Surgery

Assiut University

Status: Completed

Conditions: Postoperative Pain; Open Heart Surgery

Treatments: Drug: Bupivacaine only; Drug: bupivacain with magnesium sulphate; Drug: conventional

Study type: Interventional

Funder types: Other

Identifiers

NCT03106818

IRB00009911

Details and patient eligibility

About

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.

Full description

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

Enrollment: 90 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups

group A

Active Comparator group

Description:

( bupivacain 0.125% magnesium sulfate 5%) infusion in the presternum , for 48 hours

Treatment:

Drug: bupivacain with magnesium sulphate

group B

Active Comparator group

Description:

bupivacaine 0.125% infusion in the presternum , for 48 hours

Treatment:

Drug: Bupivacaine only

Group C

Active Comparator group

Description:

will be conventional , will receive postoperative fentanyl , paracetamol , and ketorolac.

Treatment:

Drug: conventional