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

NCT05363540 | Completed

• 1 other identifier: RC.1-3-2022
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Acute

Outcome Measures

Primary Outcomes (1)

• Amount of rescue analgesia

  Total amount of opioid administered as rescue analgesia postoperative.

  24 hours postoperative

Secondary Outcomes (6)

• Intraoperative total fentanyl requirements

  during surgery

• intraoperative mean arterial blood pressure (MAP)

  during surgery (baseline, at skin incision, at sternotomy, at sternal retraction)

• pain score (VAS)

  at extubation, 12th, 16th, 20th, and 24th hour postoperative

• adverse effects

  24 hours postoperative

• patient satisfaction

  28 hours postoperative

Study Arms (2)

Pre-incisional parasternal block

ACTIVE COMPARATOR

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

Procedure: pre-incisional parasternal intercostal block

Post-incisional parasternal block

ACTIVE COMPARATOR

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

Procedure: post-incisional parasternal intercostal block

Interventions

pre-incisional parasternal intercostal block 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

Pre-incisional parasternal block

post-incisional parasternal intercostal block 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.

Post-incisional parasternal block

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Samar Rafik Amin

Banhā, Qalyubia Governorate, 13511, Egypt

Location

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia and surgical ICU

Study Record Dates

• First Submitted: April 17, 2022
• First Posted: May 6, 2022
• Study Start: March 22, 2022
• Primary Completion: November 20, 2022
• Study Completion: December 24, 2022
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

EG (1)