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Clinical Trials/NCT05518266
NCT05518266
Not yet recruiting
Not Applicable

Ultrasound-guided Versus Surgeon Delivered Post-incisional Parasternal Block in Adult Patients Undergoing Open Cardiac Surgery: Are They the Same?

Assiut University0 sites88 target enrollmentOctober 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parasternal Intercostal Nerve Block
Sponsor
Assiut University
Enrollment
88
Primary Endpoint
Change in postoperative pain score
Status
Not yet recruiting
Last Updated
3 years ago

Overview

Brief Summary

The objective of this study is to determine whether the use of post-incisional surgeon-delivered parasternal block is at least non-inferior in relieving postoperative pain in adult patients scheduled for cardiac surgery involving sternotomy compared with ultrasound-guided post-incisional PIFB.

Detailed Description

Patients will be randomly allocated (using a sequence of computer-generated random numbers) into one of two groups (44 patients in each); group P (ultrasound guided parasternal; PIFP block) and group S (surgeon delivered parasternal block). 1. group P (ultrasound guided parasternal; PIFP block): Bupivacaine 0.25 % will be injected into the fascial plane between the pectoralis major muscle and external intercostal muscle or costal cartilages on each side of sternum after skin closure under ultrasound guidance 2. Group S (surgeon delivered parasternal block). Just before wiring the sternum, the surgeon will inject bupivacaine 0.25 % in 4 mL aliquots into the anterior (2nd-6th) intercostal spaces on each side about 2 cm lateral to the sternal edge with a total volume of 40 mL under direct vision.

Registry
clinicaltrials.gov
Start Date
October 2022
End Date
December 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohamed Ahmed Ali Ahmed

Doctor

Assiut University

Eligibility Criteria

Inclusion Criteria

  • Age: from 18 to 75 years.
  • Rheumatic heart disease needing elective valve replacement (mitral, aortic, or double valve replacement) via median sternotomy and under CPB (cardiopulmonary bypass)
  • Hemodynamic stability (no evidence of heart failure, not on vasoactive drugs, and not on mechanical ventilation).

Exclusion Criteria

  • • Previous, urgent, or emergent cardiac surgery.
  • Patients undergoing coronary artery bypass grafting (CABG)
  • local infection of the skin at the site of needle puncture,
  • Allergy to bupivacaine,
  • Coagulation disorders,
  • Clinically significant liver or kidney disease,
  • Heart failure or severe pulmonary hypertension.
  • severe renal, pulmonary, liver, or endocrine systemic disease,

Outcomes

Primary Outcomes

Change in postoperative pain score

Time Frame: 24 hours

Postoperative pain score will be measured after extubation at 0, 3, 6, 12, 16, 20, and 24 hours, using a visual analog scale (VAS). We are interested in the time at which postoperative pain is most severe. The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations, The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually, 10centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. A score of 0 is "no pain and a score of 10 is "worst imaginable pain"

Secondary Outcomes

  • Amount of rescue analgesia(24 hours)

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