NCT05475561

Brief Summary

The current study is designed to compare the perioperative analgesic efficacy of Erector spinae plane block (ESPB) and Pecto-intercostal-fascial plane block (PIFB) in adults undergoing cardiac surgery via median sternotomy. The primary outcome measure will be the analgesic effectiveness of both blocks in median sternotomy pain, while the secondary outcome measures will be time to extubation, and length of intensive care unit stay.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

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

May 25, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 27, 2022

Completed
Last Updated

July 27, 2022

Status Verified

May 1, 2022

Enrollment Period

1 month

First QC Date

July 7, 2022

Last Update Submit

July 24, 2022

Conditions

Cardiac Septal Defects With Coarctation of the AortaMitral Regurgitation

Outcome Measures

Primary Outcomes (2)

  • Total dose of fentanyl consumption

    Analgesic effectiveness of both blocks in median sternotomy pain

    after 1 hour postoperative

  • Total dose of fentanyl consumption

    Analgesic effectiveness of both blocks in median sternotomy pain

    after 24 hours postoperative

Secondary Outcomes (2)

  • time to extubation

    after 1 hour of removal of endotracheal tube

  • ICU Length of stay

    after 48 hour postoperative

Study Arms (2)

Group (P)

ACTIVE COMPARATOR
Procedure: Ultrasound guided Pecto-intercostal- fascial plane blockDrug: Bupivacain

Group (E)

ACTIVE COMPARATOR
Procedure: Ultrasound guided erector spinae plane blockDrug: Bupivacain

Interventions

Ultrasound guided Pecto-intercostal- fascial plane blockPROCEDURE

The probe of the ultrasound will be placed at 2 cm lateral to the lateral sternal border at 5th and 6th rib. On the surface plane subcutaneous tissue is identified, while Pectoralis major muscle, Intercostal muscles and ribs are seen in intermediate plane and lung along with pleura are identified in deep plane. A 22-gauge, 80-mm short bevel echogenic needle is used and advanced in in-plane manner, in a caudal-to-cranial direction, until the tip of the needle is located in the fascial plane between the pectoralis major and internal intercostal muscle, where the local anesthetic will be injected.

Group (P)
Ultrasound guided erector spinae plane blockPROCEDURE

A high-frequency linear ultrasound transducer will be placed in a longitudinal orientation 3 cm lateral to the T6 spinous process corresponding to the T5 transverse process. Three muscles trapezius (uppermost), rhomboids major (middle), and erector spinae (lowermost) will be identified superior to the hyperechoic transverse process.Local infiltration with 2% of lignocaine at the site of needle insertion will be done. Using in-plane approach a 22 G short bevel needle will be inserted in caudal-cephalad direction, until the tip is deep to erector spinae muscle, as evidenced by visible hydro dissection below the muscle plane. A 20 ml of 0.25% plain bupivacaine will be injected on each side.

Group (E)
BupivacainDRUG

local anesthetic

Group (E)Group (P)

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • adult patients of either sex
  • aged 18-50 years
  • undergoing elective cardiac surgery via median sternotomy

You may not qualify if:

  • refusal to participate,
  • redo
  • urgent cardiac surgery
  • local infection of the skin at the site of needle puncture
  • allergy to bupivacaine, coagulation disorders
  • clinically significant liver or kidney disease, heart failure, moderate to severe pulmonary hypertension
  • extubation is intentionally planned to be delayed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haasan Elhoshy

Alexandria, 21615, Egypt

Location

MeSH Terms

Conditions

Cardiac Septal Defects with Coarctation of the AortaMitral Valve Insufficiency

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2022

First Posted

July 27, 2022

Study Start

May 25, 2022

Primary Completion

June 30, 2022

Study Completion

July 5, 2022

Last Updated

July 27, 2022

Record last verified: 2022-05

Locations

EG(1)