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Postoperative Pain Alleviation in Open Heart Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03106818
Recruitment Status : Completed
First Posted : April 10, 2017
Last Update Posted : November 22, 2017
Sponsor:
Information provided by (Responsible Party):
Emad Zarief , MD, Assiut University

Tracking Information
First Submitted Date  ICMJE April 4, 2017
First Posted Date  ICMJE April 10, 2017
Last Update Posted Date November 22, 2017
Actual Study Start Date  ICMJE July 2016
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2017)
postoperative pain [ Time Frame: 48 hours postoperative ]
Vas Scale
Original Primary Outcome Measures  ICMJE
 (submitted: April 7, 2017)
  • visual analog scale [ Time Frame: 48 hours postoperative ]
  • extubation time [ Time Frame: 48 hour ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2017)
  • extubation time [ Time Frame: 48 hours ]
    time to separate patient from mechanical ventilation and extubation
  • Fentanyl consumption [ Time Frame: 48 hours ]
    total fenatnyl consumption
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Postoperative Pain Alleviation in Open Heart Surgery
Official Title  ICMJE Postoperative Pain Alleviation in Patients Undergoing Cardiac Surgery; Presternal Bupivacaine and Magnesium Infiltration Versus Conventional Intravenous Analgesia
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
pain control in the early postoperative period
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Open Heart Surgery
  • Postoperative Pain
Intervention  ICMJE
  • Drug: bupivacain with magnesium sulphate
    will receive bupivacain 0.125% and magnesium sulphate 5% infusion in the presternum , for 48 hours
    Other Name: local anesthetic with adjuvant for 48 hours
  • Drug: Bupivacaine only
    will receive bupivacain 0.125% infusion in the presternum , for 48 hours
    Other Name: local anesthetic
  • Drug: conventional
    only conventional post operative analgesics will be used
    Other Name: paracetamol , Ketorolac
Study Arms  ICMJE
  • Active Comparator: group A
    ( bupivacain 0.125% magnesium sulfate 5%) infusion in the presternum , for 48 hours
    Intervention: Drug: bupivacain with magnesium sulphate
  • Active Comparator: group B
    bupivacaine 0.125% infusion in the presternum , for 48 hours
    Intervention: Drug: Bupivacaine only
  • Active Comparator: Group C
    will be conventional , will receive postoperative fentanyl , paracetamol , and ketorolac.
    Intervention: Drug: conventional
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 23, 2017)
90
Original Estimated Enrollment  ICMJE
 (submitted: April 7, 2017)
60
Actual Study Completion Date  ICMJE July 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03106818
Other Study ID Numbers  ICMJE IRB00009911
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Emad Zarief , MD, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Emad Kamel Said, MD Anesthesia departement , Faculty of Medicine , Assiut university
PRS Account Assiut University
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP