- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07315308
Preoperative Deep Parasternal Intercostal Plane Block and Intraoperative Opioid Use in Cardiac Surgery
Preoperative Ultrasound-Guided Deep Parasternal Intercostal Plane Block Reduces Intraoperative Opioid Consumption in Adults Undergoing Cardiac Surgery Via Median Sternotomy
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Adequate pain control during and after cardiac surgery via median sternotomy remains challenging despite advances in perioperative care. Opioids continue to be the mainstay of analgesia; however, excessive intraoperative opioid administration has been associated with delayed extubation, respiratory complications, postoperative nausea and vomiting, and prolonged intensive care unit stay. As part of enhanced recovery protocols, regional anesthesia techniques that provide effective opioid-sparing analgesia are increasingly emphasized.
The deep parasternal intercostal plane (DPIP) block is a relatively novel ultrasound-guided regional anesthesia technique that targets the anterior cutaneous branches of the intercostal nerves within the fascial plane between the internal intercostal and transversus thoracis muscles. Compared with more proximal neuraxial or paravertebral techniques, the DPIP block offers a more localized and anatomically specific approach to sternotomy-related pain while potentially reducing the risk of serious complications.
In this prospective, randomized controlled trial, adult patients scheduled for elective cardiac surgery via median sternotomy will be allocated to one of two parallel groups. Patients in the intervention group will receive a bilateral ultrasound-guided DPIP block performed preoperatively after induction of general anesthesia, in addition to standardized general anesthesia management. Patients in the control group will receive standardized general anesthesia alone, without a regional block. Perioperative anesthetic management, including opioid administration, will follow institutional protocols and will be guided by routine clinical parameters.
The primary objective of the study is to assess the effect of the preoperative DPIP block on total intraoperative opioid consumption. Secondary objectives include evaluation of early recovery parameters such as time to extubation, postoperative opioid requirements within the first 24 hours, postoperative pain intensity, and the occurrence of opioid-related adverse events. Safety outcomes related to the block procedure will also be recorded.
This study is designed to provide clinically relevant data on the role of the DPIP block as part of a multimodal analgesic strategy in cardiac surgery. By focusing on intraoperative opioid consumption and early recovery outcomes, the trial aims to clarify whether preoperative application of this targeted regional technique can contribute to improved perioperative management and opioid-sparing anesthesia in patients undergoing median sternotomy.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Burak Cemil BALIK, MD
- Phone Number: 905339545102
- Email: cburakbalik@hotmail.com
Study Locations
-
-
Sahinbey
-
Gaziantep, Sahinbey, Turkey (Türkiye)
- Recruiting
- Gaziantep Şehir Hastanesi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Adults aged 18 to 65 years Scheduled to undergo elective cardiac surgery via median sternotomy Planned general anesthesia Able to provide written informed consent
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Deep Parasternal Intercostal Plane Block Group
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.
|
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.
|
|
Active Comparator: Standard Analgesia (Control) Group
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.
|
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.
Standard postoperative multimodal analgesia administered according to institutional cardiac anesthesia protocols, without any regional anesthesia technique.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Intraoperative Opioid Consumption
Time Frame: From induction of general anesthesia until completion of surgery
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to First Rescue Analgesia
Time Frame: Up to 24 hours postoperatively
|
Time elapsed from arrival in the intensive care unit to the administration of the first rescue analgesic medication.
|
Up to 24 hours postoperatively
|
|
Block-Related Complications
Time Frame: Intraoperative period and first 24 postoperative hours
|
Incidence of complications related to the parasternal intercostal plane block, including but not limited to pneumothorax, vascular puncture, local anesthetic systemic toxicity, and infection.
|
Intraoperative period and first 24 postoperative hours
|
|
Intraoperative Hemodynamic Stability
Time Frame: During surgery
|
Incidence of intraoperative hemodynamic instability, defined as the need for additional opioid administration or vasoactive support in response to surgical stimulation, recorded from anesthesia records.
|
During surgery
|
|
Time to Extubation
Time Frame: From completion of surgery to successful tracheal extubation in the intensive care unit
|
Time elapsed between the end of surgery and successful tracheal extubation, recorded in minutes.
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From completion of surgery to successful tracheal extubation in the intensive care unit
|
|
Postoperative Opioid Consumption
Time Frame: First 24 hours postoperatively
|
Cumulative amount of opioids administered during the first 24 postoperative hours, expressed as intravenous morphine equivalents (mg), obtained from medical records.
|
First 24 hours postoperatively
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Parasternal block
- Multimodal analgesia
- Ultrasound-guided regional anesthesia
- Deep parasternal intercostal plane block
- Sternotomy analgesia
- Cardiac surgery pain management
- Opioid-sparing analgesia
- Anterior chest wall block
- Regional anesthesia in cardiac surgery
- Intraoperative Pain
- Intraoperative Opioid Consumption
Additional Relevant MeSH Terms
Other Study ID Numbers
- 390
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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