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

Not Applicable

Completed

• Conditions: Pain, Acute
• Interventions: Procedure: pre-incisional parasternal intercostal block; Procedure: post-incisional parasternal intercostal block

• Registration Number: NCT05363540
• Lead Sponsor: Benha University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-22
• Study First Submitted: 2022-04-17
• Study First Submitted QC: 2022-05-03
• Study First Posted: 2022-05-06
• Primary Completion: 2022-11-20
• Study Completion: 2022-12-24
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-18
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pre-incisional parasternal block	pre-incisional parasternal intercostal block	ultrasound guided parasternal intercostal block will be administrated before surgical incision.
Post-incisional parasternal block	post-incisional parasternal intercostal block	under direct vision parasternal intercostal block will be administrated after surgical incision and before closure of the sternum.

Primary Outcome Measures

Name	Time	Method
Amount of rescue analgesia	24 hours postoperative	Total amount of opioid administered as rescue analgesia postoperative.

Secondary Outcome Measures

Name	Time	Method
patient satisfaction	28 hours postoperative	0 "extremely unsatisfied" to 10 "extremely satisfied"
Intensive Care Unit (ICU) Length of Stay	up to 6 months
adverse effects	24 hours postoperative	nausea, vomiting, excessive sedation, respiratory depression
Intraoperative total fentanyl requirements	during surgery	the amount of consumed opioid during the procedure
pain score (VAS)	at extubation, 12th, 16th, 20th, and 24th hour postoperative	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."
intraoperative mean arterial blood pressure (MAP)	during surgery (baseline, at skin incision, at sternotomy, at sternal retraction)	hemodynamic variability due to surgical stimulation

Trial Locations

Locations (1)

Samar Rafik Amin; 🇪🇬 Banhā, Qalubia, Egypt