Postoperative Pain Alleviation in Open Heart Surgery

• Sponsor: Assiut University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03106818
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 3
• Actual Duration (Months): 12
• Patients Per Site Per Month: 7.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Open Heart Surgery; Postoperative Pain	Drug: bupivacain with magnesium sulphate; Drug: Bupivacaine only; Drug: conventional	N/A

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.

there is a need to evaluate and compare local magnesium with bupivacaine , in comparison to bupivacain ,and other conventional intarvenous analgesics

Study Design

• Study Type: Interventional
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: pain control in the early postoperative periodpain control in the early postoperative period
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Postoperative Pain Alleviation in Patients Undergoing Cardiac Surgery; Presternal Bupivacaine and Magnesium Infiltration Versus Conventional Intravenous Analgesia
• Actual Study Start Date: Jul 1, 2016
• Actual Primary Completion Date: Mar 1, 2017
• Actual Study Completion Date: Jul 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: group A ( bupivacain 0.125% magnesium sulfate 5%) infusion in the presternum , for 48 hours	Drug: bupivacain with magnesium sulphate; will receive bupivacain 0.125% and magnesium sulphate 5% infusion in the presternum , for 48 hours; Other Names: local anesthetic with adjuvant for 48 hours
Active Comparator: group B bupivacaine 0.125% infusion in the presternum , for 48 hours	Drug: Bupivacaine only; will receive bupivacain 0.125% infusion in the presternum , for 48 hours; Other Names: local anesthetic
Active Comparator: Group C will be conventional , will receive postoperative fentanyl , paracetamol , and ketorolac.	Drug: conventional; only conventional post operative analgesics will be used; Other Names: paracetamol , Ketorolac

Outcome Measures

Primary Outcome Measures

1. postoperative pain [48 hours postoperative]

   Vas Scale

Secondary Outcome Measures

1. extubation time [48 hours]

   time to separate patient from mechanical ventilation and extubation

2. Fentanyl consumption [48 hours]

   total fenatnyl consumption

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emad Zarief Kamel Said	Assiut		Egypt	71111

Sponsors and Collaborators

• Assiut University

Investigators

• Principal Investigator: Emad Kamel Said, MD, Anesthesia departement , Faculty of Medicine , Assiut university

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Emad Zarief , MD, lecturer of anesthesia and ICU, Assiut University
• ClinicalTrials.gov Identifier: NCT03106818
• Other Study ID Numbers: IRB00009911
• First Posted: Apr 10, 2017
• Last Update Posted: Nov 22, 2017
• Last Verified: Nov 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pain, Postoperative; Ketorolac; Magnesium Sulfate; Bupivacaine; Anesthetics, Local; Anesthetics

Study Results

No Results Posted as of Nov 22, 2017