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

Pain, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05363540
• Other study ID #: RC.1-3-2022
• Status: Completed
• Phase: N/A
• Start date: March 22, 2022
• Est. completion date: December 24, 2022

Study information

• Verified date: June 2023
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 24, 2022
• Est. primary completion date: November 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain
• Pain, Acute

Intervention

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
• 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.

Locations

Country	Name	City	State
Egypt	Samar Rafik Amin	Banha	Qalubia

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of rescue analgesia	Total amount of opioid administered as rescue analgesia postoperative.	24 hours postoperative
Secondary	Intraoperative total fentanyl requirements	the amount of consumed opioid during the procedure	during surgery
Secondary	intraoperative mean arterial blood pressure (MAP)	hemodynamic variability due to surgical stimulation	during surgery (baseline, at skin incision, at sternotomy, at sternal retraction)
Secondary	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
Secondary	adverse effects	nausea, vomiting, excessive sedation, respiratory depression	24 hours postoperative
Secondary	patient satisfaction	0 "extremely unsatisfied" to 10 "extremely satisfied"	28 hours postoperative
Secondary	Intensive Care Unit (ICU) Length of Stay		up to 6 months