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Postoperative Pain Alleviation in Open Heart Surgery

Primary Purpose

Open Heart Surgery, Postoperative Pain

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

About this trial

This is an interventional treatment trial for Open Heart Surgery

Eligibility Criteria

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

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

Sites / Locations

  • Emad Zarief Kamel Said

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

group A

group B

Group C

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

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

Outcomes

Primary Outcome Measures

postoperative pain
Vas Scale

Secondary Outcome Measures

extubation time
time to separate patient from mechanical ventilation and extubation
Fentanyl consumption
total fenatnyl consumption

Full Information

First Posted
April 4, 2017
Last Updated
November 21, 2017
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03106818
Brief Title
Postoperative Pain Alleviation in Open Heart Surgery
Official Title
Postoperative Pain Alleviation in Patients Undergoing Cardiac Surgery; Presternal Bupivacaine and Magnesium Infiltration Versus Conventional Intravenous Analgesia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
July 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 ,and other conventional intarvenous analgesics

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
pain control in the early postoperative period
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group A
Arm Type
Active Comparator
Arm Description
( bupivacain 0.125% magnesium sulfate 5%) infusion in the presternum , for 48 hours
Arm Title
group B
Arm Type
Active Comparator
Arm Description
bupivacaine 0.125% infusion in the presternum , for 48 hours
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
will be conventional , will receive postoperative fentanyl , paracetamol , and ketorolac.
Intervention Type
Drug
Intervention Name(s)
bupivacain with magnesium sulphate
Other Intervention Name(s)
local anesthetic with adjuvant for 48 hours
Intervention Description
will receive bupivacain 0.125% and magnesium sulphate 5% infusion in the presternum , for 48 hours
Intervention Type
Drug
Intervention Name(s)
Bupivacaine only
Other Intervention Name(s)
local anesthetic
Intervention Description
will receive bupivacain 0.125% infusion in the presternum , for 48 hours
Intervention Type
Drug
Intervention Name(s)
conventional
Other Intervention Name(s)
paracetamol , Ketorolac
Intervention Description
only conventional post operative analgesics will be used
Primary Outcome Measure Information:
Title
postoperative pain
Description
Vas Scale
Time Frame
48 hours postoperative
Secondary Outcome Measure Information:
Title
extubation time
Description
time to separate patient from mechanical ventilation and extubation
Time Frame
48 hours
Title
Fentanyl consumption
Description
total fenatnyl consumption
Time Frame
48 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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emad Kamel Said, MD
Organizational Affiliation
Anesthesia departement , Faculty of Medicine , Assiut university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emad Zarief Kamel Said
City
Assiut
ZIP/Postal Code
71111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Postoperative Pain Alleviation in Open Heart Surgery

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