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

NCT05191953 | Completed

• 1 other identifier: ESPBPIPB0255
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia; Analgesia; Acute Pain; Patient Controlled Analgesia

Keywords

Regional Anesthesia; Acute Pain Scores; Morphine Consumption

Outcome Measures

Primary Outcomes (1)

• Morphine consumption in the first 24 hours after surgery

  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.

  Postoperative day 1

Secondary Outcomes (6)

• Postoperative pain scores

  Postoperative day 1

• Time to extubation

  Postoperative day 1

• The number of patient requiring rescue analgesic

  Postoperative Day 1

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

  Postoperative Day 1

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

  Postoperative Day 1

Study Arms (2)

Group ESPB

ACTIVE COMPARATOR

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

Procedure: Bilateral ultrasound-guided ESPB

Group ESPB+Superficial PIPB

ACTIVE COMPARATOR

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

Procedure: Bilateral ultrasound-guided ESPB and superficial PIPB

Interventions

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.

Group ESPB

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.

Group ESPB+Superficial PIPB

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayis University

Samsun, Atakum, 55139, Turkey (Türkiye)

Location

Related Publications (5)

• Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.

  PMID: 23392233 BACKGROUND

• Khera T, Murugappan KR, Leibowitz A, Bareli N, Shankar P, Gilleland S, Wilson K, Oren-Grinberg A, Novack V, Venkatachalam S, Rangasamy V, Subramaniam B. Ultrasound-Guided Pecto-Intercostal Fascial Block for Postoperative Pain Management in Cardiac Surgery: A Prospective, Randomized, Placebo-Controlled Trial. J Cardiothorac Vasc Anesth. 2021 Mar;35(3):896-903. doi: 10.1053/j.jvca.2020.07.058. Epub 2020 Jul 24.

  PMID: 32798172 BACKGROUND

• Aydin ME, Ahiskalioglu A, Ates I, Tor IH, Borulu F, Erguney OD, Celik M, Dogan N. Efficacy of Ultrasound-Guided Transversus Thoracic Muscle Plane Block on Postoperative Opioid Consumption After Cardiac Surgery: A Prospective, Randomized, Double-Blind Study. J Cardiothorac Vasc Anesth. 2020 Nov;34(11):2996-3003. doi: 10.1053/j.jvca.2020.06.044. Epub 2020 Jun 18.

  PMID: 32665179 BACKGROUND

• de la Torre PA, Garcia PD, Alvarez SL, Miguel FJ, Perez MF. A novel ultrasound-guided block: a promising alternative for breast analgesia. Aesthet Surg J. 2014 Jan 1;34(1):198-200. doi: 10.1177/1090820X13515902. No abstract available.

  PMID: 24396082 BACKGROUND

• Dost B, Kaya C, Turunc E, Dokmeci H, Yucel SM, Karakaya D. 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. BMC Anesthesiol. 2022 Sep 16;22(1):295. doi: 10.1186/s12871-022-01832-0.

  PMID: 36114466 DERIVED

MeSH Terms

Conditions

Agnosia; Acute Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain

Study Officials

• BURHAN DOST

  Ondokuz Mayıs University Faculty of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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)'.

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: January 14, 2022
• Study Start: January 26, 2022
• Primary Completion: May 17, 2022
• Study Completion: June 25, 2022
• Last Updated: June 28, 2022

Record last verified: 2022-06

Locations

TU (1)