Postoperative Pain Alleviation in Open Heart Surgery

Postoperative Pain Clinical Trial

Official title:

Postoperative Pain Alleviation in Patients Undergoing Cardiac Surgery; Presternal Bupivacaine and Magnesium Infiltration Versus Conventional Intravenous Analgesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03106818
• Other study ID #: IRB00009911
• Status: Completed
• Phase: N/A
• First received: April 4, 2017
• Last updated: November 21, 2017
• Start date: July 2016
• Est. completion date: July 2017

Study information

• Verified date: November 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Open Heart Surgery
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• bupivacain with magnesium sulphate
will receive bupivacain 0.125% and magnesium sulphate 5% infusion in the presternum , for 48 hours
• Bupivacaine only
will receive bupivacain 0.125% infusion in the presternum , for 48 hours
• conventional
only conventional post operative analgesics will be used

Locations

Country	Name	City	State
Egypt	Emad Zarief Kamel Said	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pain	Vas Scale	48 hours postoperative
Secondary	extubation time	time to separate patient from mechanical ventilation and extubation	48 hours
Secondary	Fentanyl consumption	total fenatnyl consumption	48 hours