Presternal Bupivacaine Plus Magnesium Sulfate Infusion After Cardiac Surgery

NCT02731950 | Completed DMC

• 1 other identifier: IRB00009904
• 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

Pain; Postoperative Pain

Keywords

Sternotomy , cardiac surgery , pain

Outcome Measures

Primary Outcomes (1)

• 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)

  up to day 2 postoperative

Secondary Outcomes (1)

• serum cortisol level

  first and second postoperative day

Study Arms (2)

A magnesium

ACTIVE COMPARATOR

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

Drug: Magnesium Sulfate and Bupivacaine 0.125%

B control

NO INTERVENTION

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.

Interventions

Magnesium Sulfate and Bupivacaine 0.125% DRUG

Each patient will receive bupivacaine 0.125% with 5% magnesium sulphate by infusion through a catheter used for epidural analgesia, positioned presternal.

Also known as: study

A magnesium

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, Asyut Governorate, 71111, Egypt

Location

MeSH Terms

Conditions

Pain; Pain, Postoperative

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Emad Zarief Kamel Said, MD

  Assiut University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia and critical care Medicine

Study Record Dates

• First Submitted: March 26, 2016
• First Posted: April 8, 2016
• Study Start: April 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2017
• Last Updated: April 4, 2017

Record last verified: 2017-03

Locations

EG (1)