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Erector Spinae Plane Block in Post-operative Recovery in Cardiac Surgery With Median Sternotomy.

Primary Purpose

Sternotomy, Postoperative Pain

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ultrasound guided bilateral ESBP
Sponsored by
Kasr El Aini Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sternotomy focused on measuring Erector Spinae, Ultrasound, Sternotomy, Cardiac surgery

Eligibility Criteria

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

Inclusion Criteria:

  • patient aged from 18 to 70 years old
  • Adult congenital heart disease.
  • patients undergoing valve replacement due to valvular heart disease
  • Coronary artery bypass grafting( CABG) without great saphenous vein (GSV) harvesting.

Exclusion Criteria:

  • Emergency surgeries.
  • Allergy to opioids and local anesthetic
  • Patients on high inotropic support ( 100 ng/ kg/ min adrenaline or noradrenaline)
  • Patients with preoperative known chest disease ( pulmonary function tests showing moderate to severe restrictive or obstructive pulmonary disease
  • Long cardiopulmonary bypass (CPB) time ( more than 2 hours )
  • Difficult intubation (needs more than 3 attempts bu trained anesthesiologist for a successful endotracheal intubation.)
  • Skin lesions or infection at site of proposed needle insertion.
  • Bleeding disorders (INR >1.4 ),( platelet count <100,000/mm3 )

Sites / Locations

  • Cairo university hospitals, kasralainyRecruiting
  • KasralainyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

● Group A (n=110): will receive Ultrasound guided bilateral ESBP.

● Group B (n=110): will receive fentanyl IV infusion 2mic/kg/hr

Outcomes

Primary Outcome Measures

Time to extubation after cardiac surgery
Time to extubation after cardiac surgery (from the arrival to ICU till successful extubation)

Secondary Outcome Measures

Perioperative fentanyl consumption.
Perioperative fentanyl consumption.
pain scoring using the Numerical rating scales (NRS)
pain scoring using the Numerical rating scales (NRS) The NRS consists of a numeric version of the visual analog scale. The most common form of the NRS is a horizontal line with an eleven point numeric range. It is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible.

Full Information

First Posted
April 27, 2022
Last Updated
March 3, 2023
Sponsor
Kasr El Aini Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05356715
Brief Title
Erector Spinae Plane Block in Post-operative Recovery in Cardiac Surgery With Median Sternotomy.
Official Title
Bilateral Erector Spinae Plane Block Versus Fentanyl Infusion in Post-operative Recovery in Cardiac Surgery With Median Sternotomy. Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aim is to measure the time of extubation in patients receiving ultrasound guided bilateral Erector Spinae Plane (ESP) block after cardiac surgery .
Detailed Description
On arrival to the operating room, an I.V 20 G cannula will be inserted. . and 500 ml of ringer acetate solution will be infused within 30 minutes. .A five-lead electrocardiogram, a pulse oximeter and an noninvasive blood pressure monitor will be applied. Basal readings ( HR,blood pressur) will be recorded . Then arterial cannula will be inserted in the radial artery of the non dominant hand. Sedation with Midazolam 0.02 mg/kg will be administered at the pre- anethesia room. . Induction will be done using titrated doses of propofol (1-2 mg /kg). ,atracurium 0.5 mg /kg and 200 mcg of fentanyl patients will be randomly assigned into two groups : Group A (n=110): will receive Ultrasound guided bilateral ESBP. Group B (n=110): will receive fentanyl IV infusion 2mic/kg/hr. Patients in group A will be positioned in the lateral position , ESPB will be done under complete aseptic conditions , using , linear ultrasound probe(Philips HD11XE Ultrasound System) , to locate the ESP at the level of the fifth dorsal vertebrae , 22 G spinal needle will be used to inject 20 ml of 0.25% of bupivacaine in the ESP bilaterally, block will done by an expert anesthesiologist , who will not be included in the data collection. Patients in group B will be on fentanyl infusion 2 mcg /kg/hr. Blood pressure and heart rate will be recorded every 15 min until we go on CPB. An incremental dose of fentanyl bolus 50 mcg will be given when there is increase in the heart rate or the blood pressure by 20% from the baseline. If more than tow boluses needed, then the block will be considered as failed block .Then patients will go on CPB after heparinization and cannulation of the aorta and the venous system ( single venous or double venous ), after valve replacement or CABG done , weaning from the CPB , and inotropic support will start if needed . Then patient will be transferred to ICU mechanically ventilated on assisted control mode, FiO2 :0.6 , TV: 6ml /kg , RR: 12-16/min , PEEP:5. After fulfilling the criteria for extubation ( such as P/F ratio more than 200 , spontaneous tidal volume greater than 5 mL/kg, vital capacity greater than 15 mL/kg, maximum inspiratory pressure (MIP) greater than 25 cm H2O,, fully conscious patient , stable hemodynamics and accepted valves for the arterial blood gases and chest tube drains, patient will be extubated. All patients will be observed in the postoperative period at 4, 6, 8, 12,24 hours interval and all hemodynamics will be recorded including heart rate ,blood pressure ,the need for incremental doses of narcotics, pain assessment using the Numerical rating scales (NRS), (use numbers to rate pain), and time of extubation ( the time from the arrival to the ICU until successful extubation).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sternotomy, Postoperative Pain
Keywords
Erector Spinae, Ultrasound, Sternotomy, Cardiac surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients aged from 18-70 years old, who will undergo open heart surgery procedure through sternotomy will be included in the study. Patients will be randomly allocated into one of two groups: Group A (n=110): will receive Ultrasound guided bilateral ESBP after induction of general anesthesia. Group B (n=110): will receive fentanyl IV infusion 2mic/kg/hr after induction of General anesthesia
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
● Group A (n=110): will receive Ultrasound guided bilateral ESBP.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
● Group B (n=110): will receive fentanyl IV infusion 2mic/kg/hr
Intervention Type
Procedure
Intervention Name(s)
Ultrasound guided bilateral ESBP
Intervention Description
Patients in group A will be positioned in the lateral position , ESPB will be done under complete aseptic conditions , using , linear ultrasound probe(Philips HD11XE Ultrasound System) , to locate the ESP at the level of the fifth dorsal vertebrae , 22 G spinal needle will be used to inject 20 ml of 0.25% of bupivacaine in the ESP bilaterally, block will done by an expert anesthesiologist , who will not be included in the data collection
Primary Outcome Measure Information:
Title
Time to extubation after cardiac surgery
Description
Time to extubation after cardiac surgery (from the arrival to ICU till successful extubation)
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Perioperative fentanyl consumption.
Description
Perioperative fentanyl consumption.
Time Frame
24 hours
Title
pain scoring using the Numerical rating scales (NRS)
Description
pain scoring using the Numerical rating scales (NRS) The NRS consists of a numeric version of the visual analog scale. The most common form of the NRS is a horizontal line with an eleven point numeric range. It is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patient aged from 18 to 70 years old Adult congenital heart disease. patients undergoing valve replacement due to valvular heart disease Coronary artery bypass grafting( CABG) without great saphenous vein (GSV) harvesting. Exclusion Criteria: Emergency surgeries. Allergy to opioids and local anesthetic Patients on high inotropic support ( 100 ng/ kg/ min adrenaline or noradrenaline) Patients with preoperative known chest disease ( pulmonary function tests showing moderate to severe restrictive or obstructive pulmonary disease Long cardiopulmonary bypass (CPB) time ( more than 2 hours ) Difficult intubation (needs more than 3 attempts bu trained anesthesiologist for a successful endotracheal intubation.) Skin lesions or infection at site of proposed needle insertion. Bleeding disorders (INR >1.4 ),( platelet count <100,000/mm3 )
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Khaled A Sarham, MD
Phone
+201020067816
Email
khaled.sarhan@kasralainy.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Khaled A Sarhan, MD
Phone
+201020067816
Email
khaled.sarhan@kasralainy.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khaled Sarhan, MD
Organizational Affiliation
Lecturer of anesthesia, Cairo university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo university hospitals, kasralainy
City
Cairo
ZIP/Postal Code
11559
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
khaled sarhan, MD
Phone
+201020067816
Email
khaled.sarhan@kasralainy.edu.eg
Facility Name
Kasralainy
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Khaled Sarhan, MD
Phone
+201020067816
Email
khaled.sarhan@kasralainy.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No

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Erector Spinae Plane Block in Post-operative Recovery in Cardiac Surgery With Median Sternotomy.

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