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Completed

NCT Number: NCT05191953

ESPB vs.Combination of ESPB and Superficial PIPB in Cardiac Surgery

Cardiac surgery is associated with significant postoperative pain. Pain control is an essential part of enhanced recovery protocols. The aim of this study is to evaluate and compare the analgesic efficacies of erector spinae plane block (ESPB) and the combination of ESPB and superficial parasternal intercostal plane block (PIPB) in patients undergoing elective cardiac surgery.

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Key information

Conditions

Anesthesia Acute Pain Agnosia Analgesia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Patient Controlled Analgesia Perceptual Disorders Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ondokuz Mayis University

Samsun, Atakum, 55139, Turkey (Türkiye)

About this study

Many regional techniques have been used to manage postoperative pain in cardiac surgery, including thoracic epidural anesthesia, paravertebral, intercostal nerve block, intrathecal spinal morphine, and local infiltration. Increased risk of epidural/spinal hematoma secondary to systemic heparinization, potential hemodynamic instability, technical difficulties and complications such as pneumothorax are potential serious drawbacks. Due to the aforementioned reasons, anesthetists are understandably preferring ultrasound (US) guided interfascial plane blocks, which are generally thought to provide safer and more effective analgesia in cardiac surgery.

This study aims to evaluate and compare the effects of ESPB versus ESPB plus Superficial PIPB on pain scores and opioid consumption in patients undergoing elective cardiac surgery.

Patients will be divided into two groups:

Group ESPB:

In this group, patients will be administered bilateral ESPB (total of 40 ml, %0.25 bupivacaine) in addition to IV morphine patient-controlled analgesia (PCA) for the first 24 postoperative hours.

Group ESPB+Superficial PIPB:

In this group, patients will be administered Bilateral ESPB (total of 40 ml, %0.25 bupivacaine) and bilateral Superficial PIPB (total of 20 ml, %0.25 bupivacaine). In addition, IV morphine PCA will be administered for the first 24 postoperative hours.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • American Society of Anesthesiologists (ASA) 2-3 patients between the ages of 18-80 who are scheduled for elective cardiac surgery (coronary artery bypass graft surgery +/- 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
  • Major liver or kidney dysfunction or other pre-existing major organ dysfunction
  • Left ventricular ejection fraction <30
  • Individuals with mental health disorders (for example bipolar disorder or depression)
  • Pregnancy or breastfeeding
  • Presence of hematological disease
  • Patients with alcohol-drug addiction

Treatment and study plan

Bilateral ultrasound-guided ESPB

Procedure

Bilateral ultrasound-guided ESPB (total of 40 ml, 0.25% bupivacaine) will be performed.

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.

Bilateral ultrasound-guided ESPB and superficial PIPB

Procedure

Bilateral ultrasound-guided ESPB (total of 40 ml, %0.25 bupivacaine) and Superficial PIPB (total of 20 ml, %0.25 bupivacaine) will be performed.

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. Patients will be able to request opioids via a PCA device when their NRS score ≥4.

Secondary outcomes

  1. Postoperative pain scores

    Time frame: Postoperative day 1

    Pain at rest and while coughing will be assessed by numerical rating scale (NRS) scores at 0, 3, 6, 12, 18, and 24 hours after extubation. The NRS is an 11-point numeric scale that ranges from 0 to 10. The NRS is an 11-point scale consisting of integers from 0 to 10: 0 indicates "no pain" and 10 indicates "the worst pain ever possible." One day before the surgery, all patients will be informed about NRS and instructed on how to use a patient-controlled analgesia device.

  2. Time to extubation

    Time frame: Postoperative day 1

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

  3. The number of patient requiring rescue analgesic

    Time frame: Postoperative Day 1

    The number of patients who required rescue analgesics will be recorded at 0, 3, 6, 12, 18, and 24 hours after extubation.

  4. The incidences of post-operative nausea and vomiting (PONV)

    Time frame: Postoperative Day 1

    The severity of postoperative nausea and vomiting (PONV) will be assessed using a descriptive verbal rating scale at 0, 3, 6, 12, 18, and 24 hours after extubation. If a score of 3 or more ondansetron 4 mg IV will be administered and will repeat 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.

  5. Patient satisfaction as measured by the Revised American Pain Society Patient Outcome Questionnaire

    Time frame: Postoperative Day 1

    The Revised American Pain Society Patient Outcome Questionnaire will be used to assess satisfaction with pain expectation counseling (APS-POQ-R). The APS-POQ-R is designed for use in adult hospital pain management quality improvement activities, and it assesses six aspects of care: (1) pain severity and relief; (2) impact of pain on activity, sleep, and negative emotions; (3) side effects of treatment; (4) usefulness of pain treatment information; (5) ability to participate in pain treatment decisions; and (6) use of nonpharmacological strategies.

    Participants will rate themselves on a scale of 0 to 10. They were either severely dissatisfied or extremely satisfied, with a score of 0 indicating extreme dissatisfaction and 10 indicating extreme satisfaction.

    APS-POQ-R Turkish Version will be used for assessment.

  6. 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

Erector Spinae Plane Block Versus Its Combination With Superficial Parasternal Intercostal Plane Block for Postoperative Pain After Cardiac Surgery: A Prospective, Randomized, Double-blind Study

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 14, 2022
Registry last updated
Jun 28, 2022

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

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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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