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NCT Number: NCT04791592

Pecto-Intercostal Fascial Block vs. Transversus Thoracic Muscle Plane Block in Cardiac Surgery

In patients undergoing open cardiac surgery, pain control is an essential part of the enhanced recovery process. The current study aimed to evaluate the analgesic efficacies of ultrasound-guided pecto-intercostal fascial block and ultrasound-guided transversus thoracic muscle plane block for open cardiac surgeries. Analgesic efficacy will be assessed on the numeric rating scale (NRS) along with intraoperative and 24 h postoperative opioid consumption.

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Key information

Conditions

Pain, Postoperative Arterial Occlusive Diseases Arteriosclerosis Bites and Stings Cardiovascular Diseases Chemically-Induced Disorders Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Poisoning Postoperative Complications Signs and Symptoms Vascular Diseases Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Burhan Dost

Samsun, 55270, Turkey (Türkiye)

About this study

It has been reported that the TTMP block and PIF block produce effective postoperative analgesia for open cardiac surgeries.

The hypothesis of our study; PIF block reduces pain and analgesic consumption in the acute period (0-24 hours) similar to TTP block in patients undergoing elective cardiac surgery requiring median sternotomy.

Patients will be divided into two groups:

Group PIFB: A bilateral PIF block will be performed intraoperatively (20 ml, %0.25 bupivacaine + 1:400.000 adrenaline). In addition, IV morphine patient-controlled analgesia (PCA) will be applied postoperatively for 24 hours.

Group TTMPB: A bilateral TTMP block will be performed intraoperatively (20 ml, %0.25 bupivacaine + 1:400.000 adrenaline). In addition, IV morphine-PCA will be applied postoperatively for 24 hours.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ASA 1-3 patients between the ages of 18-80 who are scheduled for elective cardiac surgery (coronary artery bypass graft surgery with median sternotomy +/- valve replacement or isolated valve surgery)
  • BMI <35 kg / m2

Exclusion criteria

  • Emergent surgeries, redo cases, minimally invasive procedures
  • Patients who do not want to participate
  • Patients with cognitive dysfunction (patients who are not able to evaluate the verbal numerical pain scale)
  • Hypersensitivity or history of allergies to local anesthetics
  • Patients with severe major organ dysfunction (such as renal or hepatic insufficiency)
  • LVEF <30
  • Patients with psychiatric disorders
  • Pregnancy or breastfeeding
  • Presence of hematological disease
  • Patients with alcohol-drug addiction
  • Patients who use daily opioids for any reason

Treatment and study plan

Single-injection, ultrasound-guided bilateral PIF block.

Procedure

PIF block bilaterally (20 ml, 0.25% bupivacaine + 1:400.000 adrenaline). In addition, LA infiltration (10 ml, 0.25% bupivacaine) will be performed by the surgeon around the chest tube in all patients.

Intraoperative analgesia: At the end of the surgery, all patients will be given 0.05 mg/kg morphine IV.

Postoperative analgesia: Paracetamol 1 gr IV (every 6 hours) and IV PCA of 0.5 mg/ml morphine (demand dose 20µg/kg; lock out interval 6-10 min.; the 4-hour limit will be 80% of the total calculated dose).

In cases where rescue analgesia is required (NRS score ≥4) tramadol 100 mg IV will be infused within 30 minutes (max. 300 mg / day).

For postoperative nausea and vomiting prophylaxis, patients will be routinely administered ondansetron 4 mg IV 20 minutes before extubation in the intensive care unit.

Single-injection, ultrasound-guided bilateral TTMP block.

Procedure

TTMP block bilaterally (20 ml, 0.25% bupivacaine + 1:400.000 adrenaline). In addition, LA infiltration (10 ml, 0.25% bupivacaine) will be performed by the surgeon around the chest tube in all patients.

Intraoperative analgesia: At the end of the surgery, all patients will be given 0.05 mg/kg morphine IV.

Postoperative analgesia: Paracetamol 1 gr IV (every 6 hours) and IV PCA of 0.5 mg/ml morphine (demand dose 20µg/kg; lock out interval 6-10 min.; the 4-hour limit will be 80% of the total calculated dose).

In cases where rescue analgesia is required (NRS score ≥4) tramadol 100 mg IV will be infused within 30 minutes (max. 300 mg / day).

For postoperative nausea and vomiting prophylaxis, patients will be routinely administered ondansetron 4 mg IV 20 minutes before extubation in the intensive care unit.

Primary outcomes

  1. Morphine consumption in the first 24 hours after surgery

    Time frame: Postoperative day 1

    Morphine consumption in the first 24 hours will be measured by IV PCA. Patients will be able to request opioids via a PCA device when their NRS score is above 3.

Secondary outcomes

  1. Postoperative pain: NRS score

    Time frame: Postoperative Day 1

    Pain status at rest and while coughing will be assessed by NRS scores at 0, 3, 6, 12, 18, and 24 hours after extubation.In addition, the time until first analgesic requirement will be recorded. The NRS is an 11-point numeric scale which ranges from 0 to 10.

  2. Postoperative nausea and vomiting (PONV)

    Time frame: Postoperative Day 1

    The patients will be verbally evaluated according to a descriptive five-point PONV scale at 0, 3, 6, 12, 18, and 24 hours after extubation. If a score of 3 or more is registered, ondansetron 4 mg IV will be administered and repeated after 8 hours if required.The PONV scale is 0 = no nausea; 1 = slight nausea; 2 = moderate nausea; 3 = vomiting once; and 4 = vomiting more than once.

  3. Patient satisfaction

    Time frame: Postoperative Day 1

    Patients' satisfaction with pain management will be evaluated with a 5-point verbal satisfaction scale at the end of 24 hours. The Likert scale is 5 = very satisfied, 4 = satisfied, 3 = unsure, 2 = dissatisfied, 1 = very dissatisfied.

  4. The number of patient required rescue analgesic

    Time frame: Postoperative Day 1

    The number of patient requires rescue analgesic will be recorded at 0, 3, 6, 12, 18, and 24 hours after extubation.

  5. Time to extubation

    Time frame: Postoperative Day 1

    After the operation, the time until the patient is extubated will be recorded.

  6. Length of stay in the ICU

    Time frame: The time from admission to the ICU to the time of discharge to the hospital ward; during the hospital stay, an average of 7 days

    Total duration of stay in ICU will be recorded.

  7. Length of stay in the hospital

    Time frame: Measured in days admitted in the hospital, an average of 7 days

    Their stay in the hospital will be recorded.

  8. The number of patients with complications

    Time frame: Postoperative 7 days on an average

    The number of patients have any complications -directly related to the block or the drug used in the block- will be recorded.

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

Pecto-Intercostal Fascial Block Versus Transversus Thoracic Muscle Plane Block for Acute Post-sternotomy Pain After Cardiac Surgery: A Prospective, Randomized, Double-Blind Study

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 10, 2021
Registry last updated
Apr 23, 2021

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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