NCT06625580

Brief Summary

Poststernotomy pain represents a complication that can arise following cardiac surgery. Inadequately managed pain has been linked to various adverse outcomes, including myocardial ischemia, cardiac arrhythmias, heightened coagulation tendencies, pulmonary complications, and elevated incidences of delirium and wound infections. The Erector Spinae Plane (ESP) block, Serratus Anterior Plane (SAP) block, and Transverse Thoracic Muscle Plane (TTMP) block are demonstrated as effective regional anesthesia techniques for sternotomy pain. While these blocks differ in ease of application and efficacy, the optimal analgesic approach for cardiac surgery remains unclear. The aim of this study is to compare the analgesic efficacy of ultrasound-guided SAP and TTMP blocks combination versus ESP block administered alone in patients undergoing open heart surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 3, 2024

Completed
Last Updated

October 3, 2024

Status Verified

August 1, 2023

Enrollment Period

10 months

First QC Date

September 22, 2024

Last Update Submit

October 1, 2024

Conditions

Pain, AcutePain, Chest

Outcome Measures

Primary Outcomes (1)

  • Postoperative opioid consumption

    postoperative opioid consumption will be recorded for 48 hours

    Postoperative 48 hours

Secondary Outcomes (1)

  • Postoperative Visual Analog Scale

    Postoperative 48 hours

Study Arms (2)

ultrasound guided transverse thoracic muscle plane block and serratus anterior plane block

ACTIVE COMPARATOR

ultrasound guided transverse thoracic muscle plane block and serratus anterior plane block will be performed with %0.25 bupivacaine

Procedure: transverse thoracic muscle plane and serratus anterior plane block

ultrasound guided erector spinae plane block

ACTIVE COMPARATOR

ultrasound guided erector spinae plane block

Procedure: erector spinae plane block

Interventions

transverse thoracic muscle plane and serratus anterior plane blockPROCEDURE

ultrasound guided transverse thoracic muscle plane block and serratus anterior plane block will be performed with 0.25% bupivacaine

ultrasound guided transverse thoracic muscle plane block and serratus anterior plane block
erector spinae plane blockPROCEDURE

ultrasound guided erector spinae plane block will be performed with 0.25% bupivacaine

ultrasound guided erector spinae plane block

Eligibility Criteria

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

You may qualify if:

  • Cardiac Surgery with median sternotomy (valvular and coronary surgeries)

You may not qualify if:

  • Minimal invasive cardiac surgeries
  • Revision surgeries (during postoperative 48 hours)
  • Redo cardiac surgeries
  • Any contraindications for regional anesthesia technique (any allergies for local anesthetics)
  • Preoperative chronic opioid usage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University

Erzurum, Turkey (Türkiye)

Location

Related Publications (2)

  • Aydin ME, Ahiskalioglu A, Ates I, Tor IH, Borulu F, Erguney OD, Celik M, Dogan N. Efficacy of Ultrasound-Guided Transversus Thoracic Muscle Plane Block on Postoperative Opioid Consumption After Cardiac Surgery: A Prospective, Randomized, Double-Blind Study. J Cardiothorac Vasc Anesth. 2020 Nov;34(11):2996-3003. doi: 10.1053/j.jvca.2020.06.044. Epub 2020 Jun 18.

    PMID: 32665179BACKGROUND

  • Muhammad QUA, Sohail MA, Azam NM, Bashir HH, Islam H, Ijaz R, Aquil S, Mansoor T, Dhakal B, Fatima T, Noor J, Khan AS, Iqbal A, Khatri M, Kumar S. Analgesic efficacy and safety of erector spinae versus serratus anterior plane block in thoracic surgery: a systematic review and meta-analysis of randomized controlled trials. J Anesth Analg Crit Care. 2024 Jan 12;4(1):3. doi: 10.1186/s44158-023-00138-y.

    PMID: 38217050BACKGROUND

MeSH Terms

Conditions

Acute PainChest Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Muhammet Enes Aydin

    Associate Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 22, 2024

First Posted

October 3, 2024

Study Start

September 1, 2023

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

October 3, 2024

Record last verified: 2023-08

Locations

TU(1)