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Pecto-intercostal Fascial Plane Block for Postoperative Analgesia and Recovery Profile After Off-Pump Coronary Artery Bypass Surgery

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ultrasound guided pecto-intercostal Fascial Plane Block using bupivacaine
Ultrasound guided pecto-intercostal Fascial Plane Block using normal saline
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: NYHA ( New york heart association ) class I- III Exclusion Criteria: Parents' refusal to study participation. Patients with poor coronary vessels targets. Patients with poor cardiac systolic function or preoperative hemodynamic unstability Redo coronary artery bypass surgery Intraoperative complication need conversion to on pump surgery Postoperative exploration for bleeding or poor coronary revascularization Advanced COPD(chronic obstructive pulmonary disease) patients. Myopathies and myasthenic patients Allergy to study medications

Sites / Locations

  • Ain shams university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ultrasound guided pectointercostal fascial plane block group

control group

Arm Description

using 20 mL of 0.25% bupivacaine with adrenaline 1:400,000

using 20 mL of normal saline 0.9%

Outcomes

Primary Outcome Measures

visual analogue score
0 (no pain) and 10 (worst possible pain)
visual analogue score
0 (no pain) and 100 (worst possible pain)
visual analogue score
0 (no pain) and 100 (worst possible pain)
visual analogue score
0 (no pain) and 100 (worst possible pain)
visual analogue score
0 (no pain) and 100 (worst possible pain)
visual analogue score
0 (no pain) and 100 (worst possible pain)
visual analogue score
0 (no pain) and 100 (worst possible pain)
visual analogue score
0 (no pain) and 100 (worst possible pain)

Secondary Outcome Measures

Total intraoperative opioid consumption
Total postoperative opioid consumption
Number of patients need postoperative rescue tramadol
Time to patient extubation
time for ICU discharge
postoperative complication

Full Information

First Posted
March 4, 2023
Last Updated
July 20, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05774249
Brief Title
Pecto-intercostal Fascial Plane Block for Postoperative Analgesia and Recovery Profile After Off-Pump Coronary Artery Bypass Surgery
Official Title
The Value of Adding Pecto-intercostal Fascial Plane Block on the Postoperative Analgesia and Recovery Profile After Off-Pump Coronary Artery Bypass Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 20, 2023 (Actual)
Primary Completion Date
March 20, 2023 (Actual)
Study Completion Date
July 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams 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
Moderate to severe postoperative pain is usually encountered after cardiac surgery.Improper postoperative pain control could have multiple hemodynamic hazards in addition to prolonged postoperative ventilatory support and intensive care unit stay .The safety and efficacy of ultrasound guided chest wall plane blocks has been described for postoperative analgesia after cardiac surgeries. Study objective: to investigate the effect of adding of pecto-intercostal fascial plane block on the postoperative pain control, perioperative analgesic consumptions and the time for ventilation weaning and intensive care unit discharge in patients who will undergo off-pump Coronary artery bypass surgeries. Methods: This study patients will be randomly assigned to 2 Groups to receive preoperative ultrasound-guided pecto-intercostal fascial plane block with either 20 mL of 0.25% bupivacaine with adrenaline 1:400,000 or saline bilaterally.
Detailed Description
After preoperative patients' anesthesia assessment; the study patients (20 in each group) will receive general anesthesia under invasive monitoring of hemodynamics, and oxygen saturation. After anesthesia induction; cannulation of jugular vein and insertion of transoesophageal echocardiography and temperature probe will be done. In block group : while Patients in supine decubitus position,parasternal area will be scanned using high frequency ultrasound linear probe .After identification of ribs with intercostal spaces in between ;the fourth intercostal space will be approached via 10 cm block needle targeting the plane between pectoralis major and external intercostal muscle under ultrasound guidance after which 20 mL of 0.25% bupivacaine with adrenaline 1:400,000 will be administered in increments bilaterally. In control group:Sham Block will be done using 20 mL of normal saline 0.9% bilaterally . Anesthesia will be maintained with sevoflurane inhalational anesthesia and incremental cisatracurium and fentanyl for intraoperative muscle relaxation and analgesia respectively. Intraoperative anticoagulation will be carried out before revascularization using intravenous heparin titrated according to activated clotting time ,which will be reversed after end of surgery using protamine sulfate. At the end of surgery patients will be sent to post cardiac surgery intensive care unit . Postoperative analgesia in the form of intravenous paracetamol one gram will be administered on intensive care unit admission then fentanyl based patient controlled analgesia will be started . IV tramadol 1mg/kg as second rescue analgesia will be given if visual analogue scores are still ≥ 4.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound guided pectointercostal fascial plane block group
Arm Type
Active Comparator
Arm Description
using 20 mL of 0.25% bupivacaine with adrenaline 1:400,000
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
using 20 mL of normal saline 0.9%
Intervention Type
Procedure
Intervention Name(s)
Ultrasound guided pecto-intercostal Fascial Plane Block using bupivacaine
Intervention Description
while Patients in supine decubitus position,parasternal area will be scanned using high frequency ultrasound linear probe .After identification of ribs with intercostal spaces in between ;the fourth intercostal space will be approached via 10 cm block needle targeting the plane between pectoralis major and external intercostal muscle under ultrasound guidance after which 20 mL of 0.25% bupivacaine with adrenaline 1:400,000 will be administered in increments bilaterally.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound guided pecto-intercostal Fascial Plane Block using normal saline
Intervention Description
Sham Block will be done while Patients in supine decubitus position,parasternal area will be scanned using high frequency ultrasound linear probe .After identification of ribs with intercostal spaces in between ;the fourth intercostal space will be approached via 10 cm block needle targeting the plane between pectoralis major and external intercostal muscle under ultrasound guidance after which 20 mL of normal saline 0.9 % will be administered bilaterally.
Primary Outcome Measure Information:
Title
visual analogue score
Description
0 (no pain) and 10 (worst possible pain)
Time Frame
immediately after extubation
Title
visual analogue score
Description
0 (no pain) and 100 (worst possible pain)
Time Frame
1 st hour after extubation
Title
visual analogue score
Description
0 (no pain) and 100 (worst possible pain)
Time Frame
2 nd hour after extubation
Title
visual analogue score
Description
0 (no pain) and 100 (worst possible pain)
Time Frame
4 th hour after extubation
Title
visual analogue score
Description
0 (no pain) and 100 (worst possible pain)
Time Frame
8 th hour after extubation
Title
visual analogue score
Description
0 (no pain) and 100 (worst possible pain)
Time Frame
12 th hour after extubation
Title
visual analogue score
Description
0 (no pain) and 100 (worst possible pain)
Time Frame
18 th hour after extubation
Title
visual analogue score
Description
0 (no pain) and 100 (worst possible pain)
Time Frame
24 th hour after extubation
Secondary Outcome Measure Information:
Title
Total intraoperative opioid consumption
Time Frame
during the operation
Title
Total postoperative opioid consumption
Time Frame
24 hour after operation
Title
Number of patients need postoperative rescue tramadol
Time Frame
24 hours after extubation
Title
Time to patient extubation
Time Frame
at the end of surgery
Title
time for ICU discharge
Time Frame
72 hours after surgery
Title
postoperative complication
Time Frame
72 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: NYHA ( New york heart association ) class I- III Exclusion Criteria: Parents' refusal to study participation. Patients with poor coronary vessels targets. Patients with poor cardiac systolic function or preoperative hemodynamic unstability Redo coronary artery bypass surgery Intraoperative complication need conversion to on pump surgery Postoperative exploration for bleeding or poor coronary revascularization Advanced COPD(chronic obstructive pulmonary disease) patients. Myopathies and myasthenic patients Allergy to study medications
Facility Information:
Facility Name
Ain shams university
City
Cairo
ZIP/Postal Code
20
Country
Egypt

12. IPD Sharing Statement

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Pecto-intercostal Fascial Plane Block for Postoperative Analgesia and Recovery Profile After Off-Pump Coronary Artery Bypass Surgery

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