Optimal Timing of Parasternal Intercostal Nerve Block Application for Acute Pain Management in Cardiac Surgery
Primary Purpose
Pain, Acute
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
pre-incisional parasternal intercostal block
post-incisional parasternal intercostal block
Sponsored by
About this trial
This is an interventional prevention trial for Pain, Acute
Eligibility Criteria
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.
Sites / Locations
- Samar Rafik Amin
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Pre-incisional parasternal block
Post-incisional parasternal block
Arm Description
ultrasound guided parasternal intercostal block will be administrated before surgical incision.
under direct vision parasternal intercostal block will be administrated after surgical incision and before closure of the sternum.
Outcomes
Primary Outcome Measures
Amount of rescue analgesia
Total amount of opioid administered as rescue analgesia postoperative.
Secondary Outcome Measures
Intraoperative total fentanyl requirements
the amount of consumed opioid during the procedure
intraoperative mean arterial blood pressure (MAP)
hemodynamic variability due to surgical stimulation
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."
adverse effects
nausea, vomiting, excessive sedation, respiratory depression
patient satisfaction
0 "extremely unsatisfied" to 10 "extremely satisfied"
Intensive Care Unit (ICU) Length of Stay
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05363540
Brief Title
Optimal Timing of Parasternal Intercostal Nerve Block Application for Acute Pain Management in Cardiac Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 22, 2022 (Actual)
Primary Completion Date
November 20, 2022 (Actual)
Study Completion Date
December 24, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pre-incisional parasternal block
Arm Type
Active Comparator
Arm Description
ultrasound guided parasternal intercostal block will be administrated before surgical incision.
Arm Title
Post-incisional parasternal block
Arm Type
Active Comparator
Arm Description
under direct vision parasternal intercostal block will be administrated after surgical incision and before closure of the sternum.
Intervention Type
Procedure
Intervention Name(s)
pre-incisional parasternal intercostal block
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
post-incisional parasternal intercostal block
Intervention Description
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.
Primary Outcome Measure Information:
Title
Amount of rescue analgesia
Description
Total amount of opioid administered as rescue analgesia postoperative.
Time Frame
24 hours postoperative
Secondary Outcome Measure Information:
Title
Intraoperative total fentanyl requirements
Description
the amount of consumed opioid during the procedure
Time Frame
during surgery
Title
intraoperative mean arterial blood pressure (MAP)
Description
hemodynamic variability due to surgical stimulation
Time Frame
during surgery (baseline, at skin incision, at sternotomy, at sternal retraction)
Title
pain score (VAS)
Description
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."
Time Frame
at extubation, 12th, 16th, 20th, and 24th hour postoperative
Title
adverse effects
Description
nausea, vomiting, excessive sedation, respiratory depression
Time Frame
24 hours postoperative
Title
patient satisfaction
Description
0 "extremely unsatisfied" to 10 "extremely satisfied"
Time Frame
28 hours postoperative
Title
Intensive Care Unit (ICU) Length of Stay
Time Frame
up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Samar Rafik Amin
City
Banhā
State/Province
Qalubia
ZIP/Postal Code
13511
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Optimal Timing of Parasternal Intercostal Nerve Block Application for Acute Pain Management in Cardiac Surgery
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