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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-26

Study Completion Date

2022-06-25

Brief Summary

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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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Detailed Description

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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.

Conditions

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Anesthesia Analgesia Acute Pain Patient Controlled Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A block randomization list will be created by a doctor who does not participate in patient follow-up using a web-based program, 'Research Randomizer (Urbaniak and Plous 2013)'.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Sealed opaque envelopes containing study participation numbers will be used for the purpose of assigning each patient. A researcher not involved in patient followup will use the web based "Research Randomizer'' (Urbaniak and Plous 2013) tool in order to assign each participation number into a random group with a 1:1 ratio.

A nurse that is not an active investigator in the study will have each participant choose an envelope that contains the study participation number. An assistant not active in the study will inform the anesthetist who will administer the block/blocks about which group the patient is in, immediately prior to administration. Researchers, patients, surgeons, and nurses will not be aware of the randomization of groups.

Study Groups

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Group ESPB

A bilateral ESPB (40 ml, %0.25 bupivacaine, totally) + IV morphine-PCA

Group Type ACTIVE_COMPARATOR

Bilateral ultrasound-guided ESPB

Intervention Type 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.

Group ESPB+Superficial PIPB

A bilateral ESPB (40 ml, %0.25 bupivacaine, totally) and a bilateral superficial PIPB (20 ml, %0.25 bupivacaine, totally) + IV morphine-PCA

Group Type ACTIVE_COMPARATOR

Bilateral ultrasound-guided ESPB and superficial PIPB

Intervention Type 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.

Interventions

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Bilateral ultrasound-guided ESPB

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.

Intervention Type PROCEDURE

Bilateral ultrasound-guided ESPB and superficial PIPB

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No