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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04094532
Other study ID # AUTF ANESTHESIACARDIAC
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2019
Est. completion date January 15, 2020

Study information

Verified date January 2020
Source Ataturk University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date January 15, 2020
Est. primary completion date January 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Bupivacaine
Ultrasound guided 20 ml % 0.250 bupivacaine injection to transverse thoracic muscle plane bilaterally
Saline
Ultrasound guided 20 ml % 0.9 saline injection to transverse thoracic muscle plane bilaterally

Locations

Country Name City State
Turkey Ataturk University Erzurum Yakutiye

Sponsors (1)

Lead Sponsor Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative opioid consumption First 24 hours total fentanyl consumption with patient controlled analgesia first 24 hours
Secondary Visual analog pain score Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) postextubation 0-24 hours
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