NCT04094532

Brief Summary

Poststernotomy pain is a complication of cardiac surgery. Poorly controlled pain is associated with myocardial ischemia, cardiac arrhythmias, hypercoagulability, pulmonary complications, and increased rates of delirium and wound infection. The transverse thoracic muscle plane (TTMP) block is a novel plane block that provide pain for sternotomy. The aim of this study was to evaluate the analgesic effect of ultrasound guided TTMP block 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
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

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

First Submitted

Initial submission to the registry

September 17, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 19, 2019

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2020

Completed
Last Updated

January 29, 2020

Status Verified

January 1, 2020

Enrollment Period

3 months

First QC Date

September 17, 2019

Last Update Submit

January 28, 2020

Conditions

Pain, AcutePain, Chest

Outcome Measures

Primary Outcomes (1)

  • Postoperative opioid consumption

    First 24 hours total fentanyl consumption with patient controlled analgesia

    first 24 hours

Secondary Outcomes (1)

  • Visual analog pain score

    postextubation 0-24 hours

Study Arms (2)

ultrasound guided transverse thoracic muscle plane block

ACTIVE COMPARATOR
Drug: Bupivacaine

ultrasound guided sham block

SHAM COMPARATOR
Drug: Saline

Interventions

BupivacaineDRUG

Ultrasound guided 20 ml % 0.250 bupivacaine injection to transverse thoracic muscle plane bilaterally

ultrasound guided transverse thoracic muscle plane block
SalineDRUG

Ultrasound guided 20 ml % 0.9 saline injection to transverse thoracic muscle plane bilaterally

ultrasound guided sham block

Eligibility Criteria

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

You may qualify if:

  • American Society of Anesthesiologist's physiologic state I-III patients Undergoing Open Heart Surgery

You may not qualify if:

  • chronic pain bleeding disorders renal or hepatic insufficiency patients on chronic non-steroidal anti-inflammatory medications emergency cases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University

Erzurum, Yakutiye, 25100, Turkey (Türkiye)

Location

Related Publications (1)

  • Murata H, Hida K, Hara T. Transverse Thoracic Muscle Plane Block: Tricks and Tips to Accomplish the Block. Reg Anesth Pain Med. 2016 May-Jun;41(3):411-2. doi: 10.1097/AAP.0000000000000374. No abstract available.

    PMID: 27093277BACKGROUND

MeSH Terms

Conditions

Acute PainChest Pain

Interventions

BupivacaineSodium Chloride

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 17, 2019

First Posted

September 19, 2019

Study Start

October 1, 2019

Primary Completion

January 1, 2020

Study Completion

January 15, 2020

Last Updated

January 29, 2020

Record last verified: 2020-01

Locations

TU(1)