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

Postoperative Pain Clinical Trial

Official title:

Bilateral Erector Spinae Plane Block Versus Fentanyl Infusion in Post-operative Recovery in Cardiac Surgery With Median Sternotomy. Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05356715
• Other study ID #: MD-394-2021
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: October 30, 2023

Study information

• Verified date: November 2023
• Source: Kasr El Aini Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: October 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 )

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain
• Sternotomy

Intervention

Procedure:
• Ultrasound guided bilateral ESBP
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

Locations

Country	Name	City	State
Egypt	Cairo university hospitals, kasralainy	Cairo
Egypt	Kasralainy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to extubation after cardiac surgery	Time to extubation after cardiac surgery (from the arrival to ICU till successful extubation)	24 hours
Secondary	Perioperative fentanyl consumption.	Perioperative fentanyl consumption.	24 hours
Secondary	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.	24 hours