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

Optimal Timing of Parasternal Intercostal Nerve Block Application (Pre-incisional Versus Post-incisional) for Acute Pain Management in Cardiac Surgery; a Randomized Double Blinded Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Pain, Acute
• Intervention / Treatment: Procedure: pre-incisional parasternal intercostal block; Procedure: post-incisional parasternal intercostal block

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Qalubia
    • Banhā, Qalubia, Egypt, 13511
      • Samar Rafik Amin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pre-incisional parasternal block; ultrasound guided parasternal intercostal block will be administrated before surgical incision.	Procedure: 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
Active Comparator: Post-incisional parasternal block; under direct vision parasternal intercostal block will be administrated after surgical incision and before closure of the sternum.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of rescue analgesia	Total amount of opioid administered as rescue analgesia postoperative.	24 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative total fentanyl requirements	the amount of consumed opioid during the procedure	during surgery
intraoperative mean arterial blood pressure (MAP)	hemodynamic variability due to surgical stimulation	during surgery (baseline, at skin incision, at sternotomy, at sternal retraction)
pain score (VAS)	VAS scores will be recorded by making a handwritten mark on a 10-cm line that represented a continuum between "no pain" and "worst possible pain."	at extubation, 12th, 16th, 20th, and 24th hour postoperative
adverse effects	nausea, vomiting, excessive sedation, respiratory depression	24 hours postoperative
patient satisfaction	0 "extremely unsatisfied" to 10 "extremely satisfied"	28 hours postoperative
Intensive Care Unit (ICU) Length of Stay		up to 6 months

Collaborators and Investigators

• Sponsor: Benha University

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2022
• Primary Completion (Actual): November 20, 2022
• Study Completion (Actual): December 24, 2022

Study Registration Dates

• First Submitted: April 17, 2022
• First Submitted That Met QC Criteria: May 3, 2022
• First Posted (Actual): May 6, 2022

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 18, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: RC.1-3-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No