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Presternal Bupivacaine Plus Magnesium Sulfate Infusion After Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT02731950
Recruitment Status : Completed
First Posted : April 8, 2016
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Emad Zarief , MD, 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.


Condition or disease Intervention/treatment Phase
Pain Postoperative Pain Drug: Magnesium Sulfate and Bupivacaine 0.125% Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: 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.
Study Start Date : April 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Active Comparator: A magnesium

Consists of 20 patients:

Each receive bupivacaine 0.125% with 5% magnesium sulfate by infusion through a small diameter multi-hole soft catheter generally used for epidural analgesia positioned anterior to the sternum above the fascia in the subcutaneous tissue during wound closure for 48 hours postoperative. A bolus of 5 ml of the study solution will be injected in the catheter after aspiration test before connection to infusion pump that delivers continuous infusion pump that delivers continuous infusion at a fixed rate of 5 ml/h.

postoperative : 25 µg fentanyl for breakthrough pain. placebo will be given in same intravenous instead of paracetamol and ketorolac of group B , to keep the investigator blinded

Drug: Magnesium Sulfate and Bupivacaine 0.125%
Each patient will receive bupivacaine 0.125% with 5% magnesium sulphate by infusion through a catheter used for epidural analgesia, positioned presternal.
Other Name: study

No Intervention: B control

Consists of 20 patients:

saline as placebo infusion through a small diameter multi-hole soft catheter positioned anterior to the sternum above the fascia in the subcutaneous tissue during wound closure for 48 Postoperative pain control will be managed with 1gm paracetamol /6 hr, Ketorolac 30 mg every 8-12 hour .25 µg fentanyl for breakthrough pain.




Primary Outcome Measures :
  1. Pain assessment using a VAS [ Time Frame: up to day 2 postoperative ]
    Pain 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 Outcome Measures :
  1. serum cortisol level [ Time Frame: first and second postoperative day ]
    assessing evening serum cortisol



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02731950


Locations
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Egypt
Emad Zarief Kamel Said
Assiut, Egypt, 71111
Sponsors and Collaborators
Assiut University
Investigators
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Study Director: Emad Zarief Kamel Said, MD Assiut University

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Responsible Party: Emad Zarief , MD, Lecturer of Anesthesia and critical care Medicine, Assiut University
ClinicalTrials.gov Identifier: NCT02731950     History of Changes
Other Study ID Numbers: IRB00009904
First Posted: April 8, 2016    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Emad Zarief , MD, Assiut University:
Sternotomy , cardiac surgery , pain
Additional relevant MeSH terms:
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Magnesium Sulfate
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents