Postoperative Pain Alleviation in Open Heart Surgery

NCT03106818 | Completed

• 1 other identifier: IRB00009911
• Study Type: interventional
• Target: 90
• 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

Open Heart Surgery; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• postoperative pain

  Vas Scale

  48 hours postoperative

Secondary Outcomes (2)

• extubation time

  48 hours

• Fentanyl consumption

  48 hours

Study Arms (3)

group A

ACTIVE COMPARATOR

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

Drug: bupivacain with magnesium sulphate

group B

ACTIVE COMPARATOR

bupivacaine 0.125% infusion in the presternum , for 48 hours

Drug: Bupivacaine only

Group C

ACTIVE COMPARATOR

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

Drug: conventional

Interventions

bupivacain with magnesium sulphate DRUG

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

Also known as: local anesthetic with adjuvant for 48 hours

group A

Bupivacaine only DRUG

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

Also known as: local anesthetic

group B

conventional DRUG

only conventional post operative analgesics will be used

Also known as: paracetamol , Ketorolac

Group C

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 valve replacement 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

Interventions

Magnesium Sulfate; Anesthetics, Local; Adjuvants, Pharmaceutic; Congresses as Topic; Acetaminophen; Ketorolac

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Pharmaceutic Aids; Pharmaceutical Preparations; Specialty Uses of Chemicals; Organizations; Health Care Economics and Organizations; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Emad Kamel Said, MD

  Anesthesia departement , Faculty of Medicine , Assiut university

  PRINCIPAL INVESTIGATOR

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: pain control in the early postoperative period

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: April 10, 2017
• Study Start: July 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: July 1, 2017
• Last Updated: November 22, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)