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Postoperative Pain Alleviation in Open Heart Surgery

NCT ID: NCT03106818

Last Updated: 2017-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-07-31

Brief Summary

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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

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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

Conditions

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Open Heart Surgery Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

pain control in the early postoperative period
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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group A

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

Group Type ACTIVE_COMPARATOR

bupivacain with magnesium sulphate

Intervention Type DRUG

will receive bupivacain 0.125% and magnesium sulphate 5% infusion in the presternum , for 48 hours

group B

bupivacaine 0.125% infusion in the presternum , for 48 hours

Group Type ACTIVE_COMPARATOR

Bupivacaine only

Intervention Type DRUG

will receive bupivacain 0.125% infusion in the presternum , for 48 hours

Group C

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

Group Type ACTIVE_COMPARATOR

conventional

Intervention Type DRUG

only conventional post operative analgesics will be used

Interventions

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bupivacain with magnesium sulphate

will receive bupivacain 0.125% and magnesium sulphate 5% infusion in the presternum , for 48 hours

Intervention Type DRUG

Bupivacaine only

will receive bupivacain 0.125% infusion in the presternum , for 48 hours

Intervention Type DRUG

conventional

only conventional post operative analgesics will be used

Intervention Type DRUG

Other Intervention Names

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local anesthetic with adjuvant for 48 hours local anesthetic paracetamol , Ketorolac

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Emad Zarief , MD

lecturer of anesthesia and ICU

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emad Kamel Said, MD

Role: PRINCIPAL_INVESTIGATOR

Anesthesia departement , Faculty of Medicine , Assiut university

Locations

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Emad Zarief Kamel Said

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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IRB00009911

Identifier Type: -

Identifier Source: org_study_id