NCT05356715

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
239

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 2, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

1.8 years

First QC Date

April 27, 2022

Last Update Submit

November 3, 2023

Conditions

SternotomyPostoperative Pain

Keywords

Erector SpinaeUltrasoundSternotomyCardiac surgery

Outcome Measures

Primary Outcomes (1)

  • Time to extubation after cardiac surgery

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

    24 hours

Secondary Outcomes (2)

  • Perioperative fentanyl consumption.

    24 hours

  • pain scoring using the Numerical rating scales (NRS)

    24 hours

Study Arms (2)

Group A

EXPERIMENTAL

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

Procedure: Ultrasound guided bilateral ESBP

Group B

ACTIVE COMPARATOR

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

Procedure: Ultrasound guided bilateral ESBP

Interventions

Ultrasound guided bilateral ESBPPROCEDURE

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

Group AGroup B

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 )

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cairo university hospitals, kasralainy

Cairo, 11559, Egypt

Location

Kasralainy

Cairo, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Khaled Sarhan, MD

    Lecturer of anesthesia, Cairo university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

April 27, 2022

First Posted

May 2, 2022

Study Start

January 1, 2022

Primary Completion

October 30, 2023

Study Completion

October 30, 2023

Last Updated

November 7, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(2)