Presternal Magnesium With Bupivacain Versus Bupivacain Only for Postoperative Pain Relief in Open Heart Surgery

NCT03230227 | Completed

• 1 other identifier: IRB00009912
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• postoperative pain

  assessing VAS scale

  2 days

Secondary Outcomes (1)

• hemodynamics

  24 hours

Study Arms (2)

Bupivacaine magnesium

ACTIVE COMPARATOR

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

Drug: Bupivacaine magnesium

bupivacain only

ACTIVE COMPARATOR

bupivacaine 0.125% infusion in the presternum , for 48 hours

Drug: Bupivacaine only

Interventions

Bupivacaine magnesium DRUG

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

Bupivacaine magnesium

Bupivacaine only DRUG

bupivacaine 0.125% infusion in the presternum , for 48 hours

bupivacain only

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years old
• American Society of Anesthesiologists physical status II and III
• Patients scheduled for open heart surgery with sternotomy

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Emad Zarief Kamel Said

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia and ICU

Model Details: post open heart surgery pain alleviation

Study Record Dates

• First Submitted: July 14, 2017
• First Posted: July 26, 2017
• Study Start: February 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: February 1, 2017
• Last Updated: November 24, 2017

Record last verified: 2017-11

Locations

EG (1)