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Postoperative Pain Alleviation in Open Heart Surgery

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03106818
Enrollment
90
Registered
2017-04-10
Start date
2016-07-31
Completion date
2017-07-31
Last updated
2017-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open Heart Surgery, Postoperative Pain

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

Interventions

DRUGbupivacain with magnesium sulphate

will receive bupivacain 0.125% and magnesium sulphate 5% infusion in the presternum , for 48 hours

will receive bupivacain 0.125% infusion in the presternum , for 48 hours

DRUGconventional

only conventional post operative analgesics will be used

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Intervention model description

pain control in the early postoperative period

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
postoperative pain48 hours postoperativeVas Scale

Secondary

MeasureTime frameDescription
extubation time48 hourstime to separate patient from mechanical ventilation and extubation
Fentanyl consumption48 hourstotal fenatnyl consumption

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026