NCT05627869

Brief Summary

The objective of this study is to compare the effects of TTPB vs PIFB on postoperative opioid consumption in patients undergoing open cardiac surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

November 28, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

July 11, 2023

Status Verified

July 1, 2023

Enrollment Period

5 months

First QC Date

November 1, 2022

Last Update Submit

July 8, 2023

Conditions

PainPostoperative

Keywords

TTPBPIFB

Outcome Measures

Primary Outcomes (1)

  • The primary outcome will be total morphine consumption

    Total morphine consumption within 24 hours according Visual Analogue Score (VAS) for sternal pain both during rest and with cough (ranging from 0 indicating no pain to 10 indicating extreme pain). A score ≤ 3 was considered acceptable for pain relief. Supplementary rescue analgesia was administered in the form of morphine IV 0.05 mg/kg (at VAS ≥ 4).

    24 hours

Secondary Outcomes (1)

  • The secondary outcomes will be the first analgesic request time

    24 hours

Study Arms (2)

Transversus thoracic muscle plane block

ACTIVE COMPARATOR

TTPB group will receive bilateral ultrasound-guided transversus thoracic muscle plane block using 20 ml of bupivacaine 0.25% for each side.

Procedure: Transversus thoracic plane block

Pecto-intercostal fascial plane block

ACTIVE COMPARATOR

PIFB group will receive bilateral ultrasound-guided Pecto-intercostal fascial plane block using 20 ml of bupivacaine 0.25% for each side.

Procedure: Pecto intercostal fascial block

Interventions

Transversus thoracic plane blockPROCEDURE

TTPB group will receive bilateral ultrasound-guided transversus thoracic muscle plane block using 20 ml of bupivacaine 0.25% for each side.

Also known as: sunnypivacaine
Transversus thoracic muscle plane block
Pecto intercostal fascial blockPROCEDURE

PIFB group will receive bilateral ultrasound-guided Pecto-intercostal fascial plane block using 20 ml of bupivacaine 0.25% for each side.

Also known as: sunnypivacaine
Pecto-intercostal fascial plane block

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 75 years.
  • Patient scheduled to undergo elective on-pump cardiac surgery with sternotomy.
  • American Society of Anesthesiologists classification of physical status \< IV.

You may not qualify if:

  • Emergency surgery.
  • Off-pump surgery.
  • Redo surgery.
  • Ejection fraction less than 35%.
  • Refusal of the patient.
  • Known hypersensitivity to LA.
  • Chronic opioid use or chronic pain patient.
  • Psychiatric problems or communication difficulties.
  • Liver insufficiency (defined as a serum bilirubin ≥ 34 μmol/l, albumin ≤ 35 g/dl, INR ≥ 1.7)
  • Renal insufficiency (defined as a glomerular filtration rate \< 44 ml/min).
  • Obstructive sleep apnea syndrome.
  • Coexisting hematologic disorders.
  • Pregnancy or breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benisuef University Hospital

Benisuef, Egypt

RECRUITING

Related Publications (1)

  • Mansour MA, Mahmoud HE, Fakhry DM, Kassim DY. Comparison of the effects of transversus thoracic muscle plane block and pecto-intercostal fascial block on postoperative opioid consumption in patients undergoing open cardiac surgery: a prospective randomized study. BMC Anesthesiol. 2024 Feb 10;24(1):63. doi: 10.1186/s12871-024-02432-w.

    PMID: 38341525DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mariana A Mansour, Lecturer

    Benisuef university hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariana A Mansour, lecturer

CONTACT

01222960009mrmrsyk4@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anaesthesia, surgical intensive care and pain managment

Study Record Dates

First Submitted

November 1, 2022

First Posted

November 28, 2022

Study Start

February 1, 2023

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

July 11, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

TITLE

Locations

EG(1)