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Presternal Magnesium With Bupivacain Versus Bupivacain Only for Postoperative Pain Relief in Open Heart Surgery

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Bupivacaine magnesium
Bupivacaine only
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Emad Zarief Kamel Said

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Bupivacaine magnesium

bupivacain only

Arm Description

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

bupivacaine 0.125% infusion in the presternum , for 48 hours

Outcomes

Primary Outcome Measures

postoperative pain
assessing VAS scale

Secondary Outcome Measures

hemodynamics
mean arterial blood pressure

Full Information

First Posted
July 14, 2017
Last Updated
November 22, 2017
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03230227
Brief Title
Presternal Magnesium With Bupivacain Versus Bupivacain Only for Postoperative Pain Relief in Open Heart Surgery
Official Title
Presternal Local Analgesia for Postoperative Pain Relief After Open Heart Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
February 2015 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
post open heart surgery pain alleviation
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bupivacaine magnesium
Arm Type
Active Comparator
Arm Description
( bupivacain 0.125% magnesium sulfate 5%) infusion in the presternum , for 48 hours
Arm Title
bupivacain only
Arm Type
Active Comparator
Arm Description
bupivacaine 0.125% infusion in the presternum , for 48 hours
Intervention Type
Drug
Intervention Name(s)
Bupivacaine magnesium
Intervention Description
bupivacain 0.125% magnesium sulfate 5%) infusion in the presternum , for 48 hours
Intervention Type
Drug
Intervention Name(s)
Bupivacaine only
Intervention Description
bupivacaine 0.125% infusion in the presternum , for 48 hours
Primary Outcome Measure Information:
Title
postoperative pain
Description
assessing VAS scale
Time Frame
2 days
Secondary Outcome Measure Information:
Title
hemodynamics
Description
mean arterial blood pressure
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Emad Zarief Kamel Said
City
Assiut
ZIP/Postal Code
71111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Presternal Magnesium With Bupivacain Versus Bupivacain Only for Postoperative Pain Relief in Open Heart Surgery

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