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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

Tracking Information
First Submitted Date  ICMJE March 26, 2016
First Posted Date  ICMJE April 8, 2016
Last Update Posted Date April 4, 2017
Study Start Date  ICMJE April 2015
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 7, 2016)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02731950 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2017)
serum cortisol level [ Time Frame: first and second postoperative day ]
assessing evening serum cortisol
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 Presternal Bupivacaine Plus Magnesium Sulfate Infusion After Cardiac Surgery
Official Title  ICMJE 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.
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE
  • Pain
  • Postoperative Pain
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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

    Intervention: Drug: Magnesium Sulfate and Bupivacaine 0.125%
  • 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.

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: April 7, 2016)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 NCT02731950
Other Study ID Numbers  ICMJE IRB00009904
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Emad Zarief , MD, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Emad Zarief Kamel Said, MD Assiut University
PRS Account Assiut University
Verification Date March 2017

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