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Clinical Trials/NCT05363540
NCT05363540
Completed
Not Applicable

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

Benha University1 site in 1 country51 target enrollmentStarted: March 22, 2022Last updated:
ConditionsPain, Acute

Overview

Phase
Not Applicable
Status
Completed
Enrollment
51
Locations
1
Primary Endpoint
Amount of rescue analgesia

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Amount of rescue analgesia

Time Frame: 24 hours postoperative

Total amount of opioid administered as rescue analgesia postoperative.

Secondary Outcomes

  • adverse effects(24 hours postoperative)
  • intraoperative mean arterial blood pressure (MAP)(during surgery (baseline, at skin incision, at sternotomy, at sternal retraction))
  • Intraoperative total fentanyl requirements(during surgery)
  • pain score (VAS)(at extubation, 12th, 16th, 20th, and 24th hour postoperative)
  • patient satisfaction(28 hours postoperative)
  • Intensive Care Unit (ICU) Length of Stay(up to 6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Samar Rafik Mohamed Amin

lecturer of anesthesia and surgical ICU

Benha University

Study Sites (1)

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