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Completed

NCT Number: NCT06601530

Effect of Transversus Thoracic Muscle Plane Block (TTMP) on Analgesia

In this prospective and controlled study, the investigators investigated the effect of transversus thoracic muscle plane block (TTMP) on analgesia in patients who undergo coronary artery bypass graft (CABG) surgery with median sternotomy. For this purpose, the investigators aimed to compare the hemodynamic responses to surgical incision and sternotomy and, pain intensity, total analgesic consumption, additional analgesic requirements of the patients in the first 24 hours after extubation under postoperative patient-controlled analgesia (PCA) adminisration.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Istanbul University-Cerrahpasa

Istanbul, Fatih, 34098, Turkey (Türkiye)

About this study

Forty-six patients aged 18-70 years, ASA class I-III, who undergo CABG surgery were included in our study. The patients were randomized into the TTKPB group and the control group. Heart rate (HR) and mean arterial pressure (MAP) were recorded before peroperative induction, before skin incision, after skin incision, before sternotomy and after sternotomy. PCA with tramadol was applied after extubation and "Numeric rating scale" NRS scores, total tramadol consumption, number of requests and additional analgesic requirements were recorded at 0, 1, 2, 4, 8, 12 and 24 hours.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA (American Society of Anesthesiologists) classification I-III
  • Coronary artery bypass graft operation with median sternotomy under elective conditions

Exclusion criteria

  • Refusing to participate in the study
  • Under 18 and over 70
  • ASA class IV and above
  • EF (Ejection Fraction) < 40%
  • Emergency surgery or reoperation
  • Intraaortic balloon pump placement
  • Known allergy to local anesthetics
  • Coagulation disorder
  • Infection at the block site
  • History of sternotomy
  • Those with chronic pain complaints and long-term use of analgesics
  • Patients who could not be extubated within 12 hours after the operation

Treatment and study plan

Transversus Thoracic Muscle Plane Block

Procedure

Transversus thoracic muscle plane block is a single-shot nerve block technique that provides analgesia for the anterior chest wall Tramadol IV PCA (Patient Controlled Analgesia): Basal infusion 0.2 mg/kg/h, bolus 20 mg, lock time 20 minutes

Other names: Tramadol

Tramadol

Drug

Tramadol IV PCA (Patient Controlled Analgesia): Basal infusion 0.2 mg/kg/h, bolus 20 mg, lock time 20 minutes

Primary outcomes

  1. Numeric Rating Scale (NRS) at rest

    Time frame: Postoperative 24 hours

    Numeric Rating Scale (NRS) for postoperative pain

  2. Numeric Rating Scale (NRS) during coughing

    Time frame: Postoperative 24 hours

    Numeric Rating Scale (NRS) for postoperative pain

  3. Mean arterial pressure

    Time frame: Postoperative 24 hours

    Postoperative 0, 1, 2, 4, 8, 12 and 24 hours

  4. Heart rate

    Time frame: Postoperative 24 hours

    Postoperative 0, 1, 2, 4, 8, 12 and 24 hours

  5. Mean arterial pressure

    Time frame: Peroperative

    Peroperative induction, before skin incision, after skin incision, before sternotomy and after sternotomy.

  6. Heart rate

    Time frame: Peroperative

    Peroperative induction, before skin incision, after skin incision, before sternotomy and after sternotomy.

  7. Bispectral Index (BIS)

    Time frame: Peroperative

    Peroperative induction, before skin incision, after skin incision, before sternotomy and after sternotomy.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

Investigation of the Efficacy of Transversus Thoracic Muscle Plane Block in Patients Undergoing Coronary Artery Bypass Graft Surgery

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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