Preoperative Deep Parasternal Intercostal Plane Block and Intraoperative Opioid Use in Cardiac Surgery

NCT07315308 | Recruiting

• 1 other identifier: 390
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Median sternotomy is commonly used in cardiac surgery and is associated with significant intraoperative and postoperative pain, often requiring substantial opioid administration. High opioid use during cardiac surgery may contribute to adverse effects such as respiratory depression, delayed extubation, postoperative nausea and vomiting, and prolonged intensive care unit stay. Therefore, effective opioid-sparing strategies are an important component of modern perioperative care. The deep parasternal intercostal plane (DPIP) block is a regional anesthesia technique that targets the anterior cutaneous branches of the intercostal nerves, which are responsible for transmitting pain from the sternum and adjacent tissues. When performed under ultrasound guidance, this block allows precise local anesthetic deposition while minimizing the risk of pleural or vascular injury. The purpose of this randomized controlled study is to evaluate whether a preoperative ultrasound-guided DPIP block reduces intraoperative opioid consumption in adult patients undergoing elective cardiac surgery via median sternotomy. Patients will be randomly assigned to receive either a bilateral DPIP block in addition to standard general anesthesia or standard general anesthesia alone. The primary outcome of the study is total intraoperative opioid consumption. Secondary outcomes include time to extubation, postoperative opioid consumption within the first 24 hours, postoperative pain scores, and the incidence of opioid-related adverse effects. The results of this study may help define the role of the DPIP block as part of a multimodal, opioid-sparing analgesic strategy in cardiac surgery.

Conditions

Postoperative Pain; Sternotomy; Intraoperative Pain Control; Opioid Consumption

Keywords

Deep parasternal intercostal plane block; Parasternal block; Ultrasound-guided regional anesthesia; Sternotomy analgesia; Cardiac surgery pain management; Opioid-sparing analgesia; Multimodal analgesia; Anterior chest wall block; Regional anesthesia in cardiac surgery; Intraoperative Pain; Intraoperative Opioid Consumption

Outcome Measures

Primary Outcomes (1)

• Total Intraoperative Opioid Consumption

  Total amount of opioids administered intraoperatively, expressed as intravenous fentanyl equivalents (µg), adjusted for body weight (µg/kg), recorded from anesthesia records.

  From induction of general anesthesia until completion of surgery

Secondary Outcomes (5)

• Intraoperative Hemodynamic Stability

  During surgery

• Time to Extubation

  From completion of surgery to successful tracheal extubation in the intensive care unit

• Postoperative Opioid Consumption

  First 24 hours postoperatively

• Time to First Rescue Analgesia

  Up to 24 hours postoperatively

• Block-Related Complications

  Intraoperative period and first 24 postoperative hours

Study Arms (2)

Deep Parasternal Intercostal Plane Block Group

EXPERIMENTAL

Participants in this arm will receive a bilateral ultrasound-guided deep parasternal intercostal plane block following induction of general anesthesia, in addition to standard multimodal perioperative analgesia. The block will be performed in the parasternal region under real-time ultrasound guidance by injection of local anesthetic into the fascial plane between the internal intercostal and transversus thoracis muscles.

Procedure: Deep Parasternal Intercostal Plane Block

Standard Analgesia (Control) Group

ACTIVE COMPARATOR

Participants in this arm will receive standard multimodal perioperative analgesia according to institutional cardiac anesthesia protocols. No regional anesthesia techniques, including parasternal plane blocks, will be performed.

Procedure: Deep Parasternal Intercostal Plane Block; Other: Standard Multimodal Analgesia

Interventions

Standard Multimodal Analgesia OTHER

Standard postoperative multimodal analgesia administered according to institutional cardiac anesthesia protocols, without any regional anesthesia technique.

Standard Analgesia (Control) Group

Deep Parasternal Intercostal Plane Block PROCEDURE

Bilateral ultrasound-guided deep parasternal intercostal plane block performed after induction of general anesthesia, with injection of local anesthetic into the fascial plane between the internal intercostal and transversus thoracis muscles for postoperative analgesia.

Deep Parasternal Intercostal Plane Block Group; Standard Analgesia (Control) Group

Eligibility Criteria

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

You may qualify if:

• Adults aged 18 to 65 years Scheduled to undergo elective cardiac surgery via median sternotomy Planned general anesthesia Able to provide written informed consent

You may not qualify if:

• Known allergy or contraindication to local anesthetics Coagulation disorders or ongoing anticoagulant therapy that contraindicates regional anesthesia Infection at or near the planned injection site Pre-existing chronic pain conditions requiring long-term opioid use Severe cognitive impairment or inability to communicate pain intensity Emergency surgery Refusal or inability to provide informed consent

Sponsors & Collaborators

• Gaziantep City Hospital: lead

Study Sites (1)

Gaziantep Sehir Hastanesi

Gaziantep, Sahinbey, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Medeiros HJS, Rodrigue ACLF, Mueller A, Korn E, Sabouri AS. Analgesic efficacy of parasternal intercostal plane block for midline sternotomy in adult cardiac surgery: A systematic review and meta-analysis of randomized controlled trials. J Biol Methods. 2024 Nov 14;12(1):e99010033. doi: 10.14440/jbm.2024.0070. eCollection 2025.

  PMID: 40200942 BACKGROUND

• Wong HMK, Chen PY, Tang GCC, Chiu SLC, Mok LYH, Au SSW, Wong RHL. Deep Parasternal Intercostal Plane Block for Intraoperative Pain Control in Cardiac Surgical Patients for Sternotomy: A Prospective Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2024 Mar;38(3):683-690. doi: 10.1053/j.jvca.2023.11.038. Epub 2023 Nov 30.

  PMID: 38148266 BACKGROUND

• Li Q, Liao Y, Wang X, Zhan M, Xiao L, Chen Y. Efficacy of bilateral catheter superficial parasternal intercostal plane blocks using programmed intermittent bolus for opioid-sparing postoperative analgesia in cardiac surgery with sternotomy: A randomized, double-blind, placebo-controlled trial. J Clin Anesth. 2024 Aug;95:111430. doi: 10.1016/j.jclinane.2024.111430. Epub 2024 Mar 26.

  PMID: 38537393 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Burak Cemil BALIK, MD

CONTACT

905339545102; cburakbalik@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be blinded to group allocation, as the deep parasternal intercostal plane block will be performed after induction of general anesthesia. Postoperative outcome assessments, including pain scores, opioid consumption, and time to extubation, will be conducted by an independent outcome assessor who is blinded to group assignment. The anesthesiologist performing the regional block will not be blinded due to the nature of the intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Anesthesiologist

Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups. The intervention group will receive a preoperative bilateral ultrasound-guided deep parasternal intercostal plane block in addition to standardized multimodal analgesia, while the control group will receive standardized multimodal analgesia alone. All participants will undergo elective cardiac surgery via median sternotomy under general anesthesia. Outcomes will be assessed intraoperatively and during the first 24 hours postoperatively.

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 2, 2026
• Study Start: February 12, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)