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Clinical Trials/NCT03106818
NCT03106818
Completed
Not Applicable

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

Assiut University1 site in 1 country90 target enrollmentJuly 2016

Overview

Phase
Not Applicable
Intervention
bupivacain with magnesium sulphate
Conditions
Open Heart Surgery
Sponsor
Assiut University
Enrollment
90
Locations
1
Primary Endpoint
postoperative pain
Status
Completed
Last Updated
8 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
July 2016
End Date
July 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Emad Zarief , MD

lecturer of anesthesia and ICU

Assiut University

Eligibility 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

Arms & Interventions

group A

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

Intervention: bupivacain with magnesium sulphate

group B

bupivacaine 0.125% infusion in the presternum , for 48 hours

Intervention: Bupivacaine only

Group C

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

Intervention: conventional

Outcomes

Primary Outcomes

postoperative pain

Time Frame: 48 hours postoperative

Vas Scale

Secondary Outcomes

  • extubation time(48 hours)
  • Fentanyl consumption(48 hours)

Study Sites (1)

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