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Presternal Bupivacaine Plus Magnesium Sulfate Infusion After Cardiac Surgery

Primary Purpose

Pain, Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Magnesium Sulfate and Bupivacaine 0.125%
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pain focused on measuring Sternotomy , cardiac surgery , 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

No Intervention

Arm Label

A magnesium

B control

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Pain assessment using a VAS
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

serum cortisol level
assessing evening serum cortisol

Full Information

First Posted
March 26, 2016
Last Updated
March 31, 2017
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT02731950
Brief Title
Presternal Bupivacaine Plus Magnesium Sulfate Infusion After Cardiac Surgery
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 Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative Pain
Keywords
Sternotomy , cardiac surgery , pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A magnesium
Arm Type
Active Comparator
Arm Description
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
Arm Title
B control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate and Bupivacaine 0.125%
Other Intervention Name(s)
study
Intervention Description
Each patient will receive bupivacaine 0.125% with 5% magnesium sulphate by infusion through a catheter used for epidural analgesia, positioned presternal.
Primary Outcome Measure Information:
Title
Pain assessment using a VAS
Description
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)
Time Frame
up to day 2 postoperative
Secondary Outcome Measure Information:
Title
serum cortisol level
Description
assessing evening serum cortisol
Time Frame
first and second postoperative day

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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emad Zarief Kamel Said, MD
Organizational Affiliation
Assiut University
Official's Role
Study Director
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 Bupivacaine Plus Magnesium Sulfate Infusion After Cardiac Surgery

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