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Presternal Bupivacaine Plus Magnesium Sulfate Infusion After Cardiac Surgery

The Analgesic Efficacy of Magnesium Sulfate as an Adjuvant to Continuous Presternal Bupivacaine Infusion Through a Single Catheter After Cardiac Surgery; A Prospective Randomized Double Blind Study.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02731950
Enrollment
40
Registered
2016-04-08
Start date
2015-04-30
Completion date
2017-01-31
Last updated
2017-04-04

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

Conditions

Pain, Postoperative Pain

Keywords

Sternotomy , cardiac surgery , 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. postoperative pain control will be by 1gm paracetamol / 6 hr, Ketorolac tromethamine 30 mg / 8:12 hour in control group vs bupivacaine 0.125% plus magnesium sulfate 5% through a single catheter after parasternal block in in study group after cardiac surgery. The investigators primary outcome is pain scores assessment , the secondary outcomes are extubation time, postoperative respiratory parameters, serum cortisol level

Interventions

Each patient will receive bupivacaine 0.125% with 5% magnesium sulphate by infusion through a catheter used for epidural analgesia, positioned presternal.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

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

Inclusion criteria

* 18-60 years old * American Society of Anesthesiologists physical status II and III * Patients scheduled for open heart 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
Pain assessment using a VASup to day 2 postoperativePain score postoperatively on patient's arrival at the ICU, every 4 h for 12 h then every 6 h for 48 h using a VAS (0 = no pain, 10-the worst pain imaginable)

Secondary

MeasureTime frameDescription
serum cortisol levelfirst and second postoperative dayassessing evening serum cortisol

Countries

Egypt

Outcome results

None listed

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