Postoperative Pain Alleviation in Open Heart Surgery

Not Applicable

Completed

• Conditions: Open Heart Surgery; Postoperative Pain
• Interventions: Drug: conventional; Drug: bupivacain with magnesium sulphate; Drug: Bupivacaine only

• Registration Number: NCT03106818
• Lead Sponsor: Assiut University

Brief Summary

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

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

Study Timeline

• Study Start: 2016-07
• Primary Completion: 2017-03
• Study First Submitted: 2017-04-04
• Study First Submitted QC: 2017-04-07
• Study First Posted: 2017-04-10
• Study Completion: 2017-07
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-21
• Last Update Posted: 2017-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C	conventional	will be conventional , will receive postoperative fentanyl , paracetamol , and ketorolac.
group A	bupivacain with magnesium sulphate	( bupivacain 0.125% magnesium sulfate 5%) infusion in the presternum , for 48 hours
group B	Bupivacaine only	bupivacaine 0.125% infusion in the presternum , for 48 hours

Primary Outcome Measures

Name	Time	Method
postoperative pain	48 hours postoperative	Vas Scale

Secondary Outcome Measures

Name	Time	Method
extubation time	48 hours	time to separate patient from mechanical ventilation and extubation
Fentanyl consumption	48 hours	total fenatnyl consumption

Trial Locations

Locations (1)

Emad Zarief Kamel Said; 🇪🇬 Assiut, Egypt