Optimal Timing of Parasternal Intercostal Nerve Block Application for Acute Pain Management in Cardiac Surgery

NCT ID: NCT05363540

Last Updated: 2023-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-22

Study Completion Date

2022-12-24

Brief Summary

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Patients experiencing pain after undergoing cardiac surgery may also experience prolonged immobilization, insufficient respiratory functions, and the inability to cough due to median sternotomy. Therefore, duration of mechanical ventilation, length of intensive care unit (ICU) stay, and length of hospital stay of these patients will increase significantly.

many facial plane blocks have been introduced as simple and safe intervention for thoracic wall anesthesia and analgesia. Parasternal intercostal nerve block (PSIB) is a "superficial block" which involves local anesthetic (LA) infiltration in the intercostal space around the sternum where the anterior branches of intercostal nerves exist.

Intraoperative LA administration under direct vision of the surgeon ensures adequate delivery of drugs and minimizes bleeding complication or inadvertent administration in blood vessels. Meanwhile, Preoperative administration of LA guided by ultrasound imaging has been used in variable surgical settings with noticeable success because of preemptive inhibition of noxious stimuli.

Detailed Description

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Conditions

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Pain, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Pre-incisional parasternal block

ultrasound guided parasternal intercostal block will be administrated before surgical incision.

Group Type ACTIVE_COMPARATOR

pre-incisional parasternal intercostal block

Intervention Type PROCEDURE

LA will be administrated by the anesthesiologist under ultrasound guidance and before surgical incision On either side of thorax, 2 cm lateral to sternal edge from 2nd to 6th intercostal space, A volume of (4 mL) of 0.25% bupivacaine will be used

Post-incisional parasternal block

under direct vision parasternal intercostal block will be administrated after surgical incision and before closure of the sternum.

Group Type ACTIVE_COMPARATOR

post-incisional parasternal intercostal block

Intervention Type PROCEDURE

LA will be administered by the cardiac surgeon before the sternal closure. injection will introduced 2 cm lateral to sternal edge from 2nd to 6th intercostal space and volume (4 mL) of 0.25% bupivacaine will be used.

Interventions

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pre-incisional parasternal intercostal block

LA will be administrated by the anesthesiologist under ultrasound guidance and before surgical incision On either side of thorax, 2 cm lateral to sternal edge from 2nd to 6th intercostal space, A volume of (4 mL) of 0.25% bupivacaine will be used

Intervention Type PROCEDURE

post-incisional parasternal intercostal block

LA will be administered by the cardiac surgeon before the sternal closure. injection will introduced 2 cm lateral to sternal edge from 2nd to 6th intercostal space and volume (4 mL) of 0.25% bupivacaine will be used.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age from 20-70 years,
* Scheduled to undergo elective cardiac surgeries through median sternotomy involving cardiopulmonary bypass (CPB).

Exclusion Criteria

* Patients requiring preoperative inotropes, mechanical ventilation or intra-aortic balloon pump,
* patients who have previous cardiac surgery,
* prolonged CPB time (CPB\>120 minutes),
* Intubation time more than 12hrs or planned for overnight ventilation.
* Allergy to any of used drugs,
* opioids addiction,
* Chronic liver disease, chronic renal disease, and cognitive impairment.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Benha University

OTHER

Sponsor Role lead

Responsible Party

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Samar Rafik Mohamed Amin

lecturer of anesthesia and surgical ICU

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Samar Rafik Amin

Banhā, Qalyubia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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RC.1-3-2022

Identifier Type: -

Identifier Source: org_study_id

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