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ESPB Versus Combined PIPB and RIB for Analgesia in Minimally Invasive Cardiac Surgery

9 listopada 2026 zaktualizowane przez: Ankara Etlik City Hospital

Comparison of the Postoperative Analgesic Efficacy of Combined Parasternal Intercostal Plane and Rhomboid Intercostal Blocks Versus Erector Spinae Plane Block in Minimally Invasive Cardiac Surgery: A Prospective Randomized Controlled Trial

Pain after minimally invasive cardiac surgery can affect breathing, movement, and recovery. Regional anesthesia techniques may help reduce postoperative pain and the need for opioid pain medications.

This study aims to compare two ultrasound-guided regional anesthesia approaches for pain management after minimally invasive cardiac surgery: erector spinae plane block (ESPB) and a combination of parasternal intercostal plane block (PIPB) and rhomboid intercostal block (RIB).

A total of 56 adult patients undergoing minimally invasive cardiac surgery will be randomly assigned to one of two groups. One group will receive ESPB, while the other group will receive the combined PIPB and RIB technique. Both approaches will use the same total dose of local anesthetic and will be performed after induction of general anesthesia and before surgery.

The main objective is to compare how pain scores at rest change between the two groups during the first 12 hours after removal of the breathing tube. Pain will be assessed using a numerical scale from 0 (no pain) to 10 (worst imaginable pain).

The study will also evaluate postoperative opioid consumption, additional pain measurements, quality of recovery, and block-related adverse events. Quality of recovery will be assessed using the QoR-15T questionnaire before surgery and 48 hours after extubation.Patient-reported acceptability of postoperative pain management will also be evaluated using a Likert scale at 48 hours postoperatively.

The findings may help identify effective regional anesthesia strategies for postoperative pain management in minimally invasive cardiac surgery.

Przegląd badań

Szczegółowy opis

Postoperative pain management is an important component of enhanced recovery after minimally invasive cardiac surgery (MICS). Although minimally invasive approaches avoid conventional median sternotomy, patients may experience substantial pain related to the thoracic incision, intercostal tissue injury, and chest drains.

Ultrasound-guided regional anesthesia techniques are increasingly used as part of multimodal analgesia in cardiac surgery. The erector spinae plane block (ESPB) is a fascial plane block that may provide analgesia through the spread of local anesthetic across multiple thoracic segments. The combined parasternal intercostal plane block (PIPB) and rhomboid intercostal block (RIB) approach targets different regions of the thoracic wall and may provide complementary analgesic coverage.

This prospective, single-center, randomized controlled trial will compare the postoperative analgesic efficacy of unilateral ESPB with combined PIPB and RIB in 56 adult patients undergoing minimally invasive cardiac surgery.

Following induction of general anesthesia and before surgical incision, patients will receive one of two ultrasound-guided regional anesthesia approaches. The ESPB group will receive 30 mL of 0.25% bupivacaine on the surgical side. The combined-block group will receive 15 mL of 0.25% bupivacaine for PIPB and 15 mL of 0.25% bupivacaine for RIB. The total local anesthetic dose will be identical between groups.

All patients will receive standardized perioperative care and multimodal postoperative analgesia, including acetaminophen and patient-controlled tramadol analgesia.

The primary outcome will be the between-group difference in the trajectory of resting Numeric Rating Scale (NRS) pain scores at 0, 2, 4, 8, and 12 hours after extubation, evaluated through the group-by-time interaction.

Secondary outcomes will include postoperative pain measurements at additional time points, cumulative tramadol consumption during the first 24 hours, time to first rescue analgesia, postoperative quality of recovery assessed using the Turkish version of the Quality of Recovery-15 questionnaire (QoR-15T),Patient-reported acceptability of postoperative pain management will also be assessed using a Likert scale at 48 hours postoperatively and block-related adverse events.

The study aims to determine whether the combined PIPB and RIB approach offers a clinically useful alternative to ESPB for postoperative analgesia after minimally invasive cardiac surgery.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

56

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 80 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Patients aged 18-80 years.
  • Patients scheduled for elective minimally invasive cardiac surgery (MICS).
  • American Society of Anesthesiologists (ASA) physical status I-III.
  • Body mass index (BMI) between 18 and 35 kg/m².
  • Ability to communicate adequately in Turkish and participate in postoperative pain assessments.
  • Provision of written informed consent.

Exclusion Criteria:

  • Age younger than 18 years or older than 80 years.
  • ASA physical status IV.
  • BMI below 18 or above 35 kg/m².
  • Severe hepatic or renal dysfunction.
  • Pregnancy or breastfeeding.
  • Dementia, psychiatric disorders, or cognitive impairment preventing reliable cooperation or pain assessment.
  • Language barriers preventing effective communication.
  • History of alcohol, substance, or medication dependence.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: Erector Spinae Plane Block (ESPB) group

Patients allocated to this group will receive a unilateral ultrasound-guided erector spinae plane block (ESPB) at the T5 vertebral level on the surgical side after induction of general anesthesia and before surgical incision. A total of 30 mL of 0.25% bupivacaine (75 mg) will be administered.

An ultrasound-guided unilateral erector spinae plane block (ESPB) will be performed at the T5 vertebral level on the surgical side after induction of general anesthesia and before surgical incision. A total of 30 mL of 0.25% bupivacaine (75 mg) will be injected into the fascial plane between the erector spinae muscle and the transverse process.

Eksperymentalny: Combined Parasternal Intercostal Plane Block and Rhomboid Intercostal Block

Patients allocated to this group will receive a combination of ultrasound-guided parasternal intercostal plane block (PIPB) and rhomboid intercostal block (RIB) after induction of general anesthesia and before surgical incision. A total of 15 mL of 0.25% bupivacaine will be administered for PIPB and 15 mL of 0.25% bupivacaine for RIB on the surgical side. The total local anesthetic volume will be 30 mL (75 mg).

Following induction of general anesthesia and before surgical incision, patients will receive two ultrasound-guided fascial plane blocks on the surgical side. A parasternal intercostal plane block (PIPB) will be performed with 15 mL of 0.25% bupivacaine, followed by a rhomboid intercostal block (RIB) with 15 mL of 0.25% bupivacaine injected between the rhomboid major and intercostal muscles. The total administered volume will be 30 mL of 0.25% bupivacaine (75 mg).

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Postoperative Resting Pain Scores Assessed by the Numeric Rating Scale (NRS)
Ramy czasowe: At 0, 2, 4, 8, and 12 hours after extubation

Postoperative pain intensity at rest will be assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Measurements will be obtained at 0, 2, 4, 8, and 12 hours after extubation. The primary outcome will be the group-by-time interaction in resting NRS scores, comparing the erector spinae plane block (ESPB) group with the combined parasternal intercostal plane block and rhomboid intercostal block (PIPB + RIB) group using a repeated-measures statistical approach.

At 0, 2, 4, 8, and 12 hours after extubation

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Cumulative Postoperative Tramadol Consumption Within 24 Hours
Ramy czasowe: From extubation to 24 hours after extubation

Total tramadol consumption (mg) during the first 24 hours after extubation will be recorded. Postoperative patient-controlled analgesia (PCA) will be provided using tramadol with a 10 mg bolus dose, a 10-minute lockout interval, and no basal infusion. Cumulative tramadol consumption will be compared between the ESPB and combined PIPB + RIB groups. Higher consumption indicates greater postoperative opioid requirements.

From extubation to 24 hours after extubation
Postoperative Pain Score at Rest at 24 Hours
Ramy czasowe: 24 hours after extubation

Postoperative pain intensity at rest will be assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Pain scores will be recorded at 24 hours after extubation and compared between the ESPB and combined PIPB + RIB groups. Higher scores indicate greater pain intensity.

24 hours after extubation
Change in Quality of Recovery-15 Turkish Version (QoR-15T) Score
Ramy czasowe: Preoperatively (baseline) and 48 hours after extubation

Quality of postoperative recovery will be assessed using the validated Turkish version of the 15-item Quality of Recovery questionnaire (QoR-15T). The questionnaire evaluates five domains: pain, physical comfort, physical independence, psychological support, and emotional state. Each item is scored from 0 to 10, yielding a total score ranging from 0 to 150, with higher scores indicating better recovery quality. The QoR-15T will be administered preoperatively and at 48 hours after extubation. The change in total score from baseline to 48 hours will be compared between the ESPB and combined PIPB + RIB groups.

Preoperatively (baseline) and 48 hours after extubation
Patient-Reported Acceptability of Postoperative Pain Management at 48 Hours
Ramy czasowe: 48 hours after extubation

Patient-reported acceptability of postoperative pain management will be assessed using a five-point Likert scale at 48 hours after extubation. Patients will rate their agreement with the statement, "The level of pain I experienced after surgery was acceptable to me." Responses will be scored as follows: 1 = Strongly disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, and 5 = Strongly agree. Higher scores indicate greater acceptability of postoperative pain management. The distribution of responses will be compared between the ESPB and combined PIPB + RIB groups.

48 hours after extubation
Time to First Rescue Analgesia
Ramy czasowe: Within 24 hours after extubation

Time elapsed from extubation to the first administration of rescue analgesia, measured in minutes.

Within 24 hours after extubation
Incidence of Block-related Adverse Events
Ramy czasowe: Within 24 hours after block administration

Number of participants experiencing block-related adverse events, including pneumothorax and local anesthetic systemic toxicity.

Within 24 hours after block administration
Postoperative Pain Score During Movement at 24 Hours
Ramy czasowe: 24 hours after extubation

Postoperative pain intensity during movement will be assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Pain scores will be recorded at 24 hours after extubation and compared between the ESPB and combined PIPB + RIB groups. Higher scores indicate greater pain intensity.

24 hours after extubation

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Śledczy

  • Główny śledczy: havva sayhan kaplan, MD, Ankara Etlik City Hospital

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 grudnia 2026

Zakończenie podstawowe (Szacowany)

1 marca 2027

Ukończenie studiów (Szacowany)

1 marca 2027

Daty rejestracji na studia

Pierwszy przesłany

9 listopada 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

9 listopada 2026

Pierwszy wysłany (Rzeczywisty)

13 listopada 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

13 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

9 listopada 2026

Ostatnia weryfikacja

1 listopada 2026

Więcej informacji

Terminy związane z tym badaniem

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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