The Efficacy of PSB and Recto-intercostal Block Combination on Postoperative Pain in Patients Undergoing Cardiac Surgery Via Sternotomy: Case Series

August 12, 2024 updated by: Oguz Gundogdu, Cumhuriyet University

Investigation of the Postoperative Analgesic Effect of the Combination of Superficial Parasternal Block (PSB) and Recto-Intercostal(İC) Fascial Plane Block in Patients Undergoing Cardiac Surgery Via Sternotomy: Case Series

The aim of this study was to investigate the effectiveness of the combination of Superficial Parasternal Block and Recto-Intercostal Fascial Plane Block in patient groups undergoing cardiac surgery via sternotomy by evaluating postoperative pain scores and analgesic consumption.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Ten patients received a combination of parasternal block and recto-intercostal fascial plane block as an intervention. Patients received bilateral parasternal block and recto-intercostal fascial plane block with 0.25% bupivacaine (total volume 60 ml) in the operating room before surgery. All blocks will be performed after general anesthesia induction, before skin incision. All patients included in the study will be given 50 mg dexketoprofen and 1 g paracetamol intravenously (i.v.) 10 minutes before skin closure. All patients will be given 3x1 g iv paracetamol and 2x50 mg dexketoprofen within the first 24 hours postoperatively. Numerical rating scale (NRS) was used to assess pain at the 1st, 6th, 12th, 18th and 24th hours after surgery. Total morphine consumption was calculated using a patient-controlled analgesia (PCA) device. Tramadol was planned as rescue analgesic medication (maximum dose: 300 mg/day).

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients over 18 years of age who will undergo cardiac surgery with sternotomy under general anesthesia and who are in classes I-II-III according to the American Society of Anesthesiologists (ASA) risk classification.

Exclusion Criteria:

  • Patients who did not give consent,

    • patients with coagulopathy,
    • patients with signs of infection at the block application site,
    • patients using anticoagulants,
    • patients with local anesthetic drug allergies,
    • patients with unstable hemodynamics,
    • patients who could not cooperate during postoperative pain assessment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Parasternal Block and Recto-İntercostal Fascial Plane Block
Superficial PSB is performed with the patient in the supine position using a high-frequency linear USG probe. The probe is placed longitudinally 2 cm lateral to the sternal border to visualize the T2-T4 intercostal space and to identify the pectoralis major muscle, intercostal muscle, and pleura. 10 ml of 0.25% bupivacaine local anesthetic is administered between the pectoralis major and intercostal muscle using an in-plane approach with a 100 mm needle. In addition, a Recto-Intercostal Fascial Plane Block is performed with a high-frequency linear USG probe. The probe is placed 2-3 cm lateral to the xiphoid so that the rectus abdominis muscle and 6-7th cartilages are visualized. The needle is advanced to the plane between the costal cartilage and the rectus abdominis muscle using the in-plane technique and 1-2 ml of saline is injected. After observing the spread to the target plane, 20 ml of 0.25% bupivacaine is applied. The same process is repeated bilaterally.
Other: Parasternal Block and Recto-İntercostal Fascial Plane Block
Superficial PSB is performed with the patient in the supine position using a high-frequency linear USG probe. The probe is placed longitudinally 2 cm lateral to the sternal border to visualize the T2-T4 intercostal space and to identify the pectoralis major muscle, intercostal muscle, and pleura. 10 ml of 0.25% bupivacaine local anesthetic is administered between the pectoralis major and intercostal muscle using an in-plane approach with a 100 mm needle. In addition, a Recto-Intercostal Fascial Plane Block is performed with a high-frequency linear USG probe. The probe is placed 2-3 cm lateral to the xiphoid so that the rectus abdominis muscle and 6-7th cartilages are visualized. The needle is advanced to the plane between the costal cartilage and the rectus abdominis muscle using the in-plane technique and 1-2 ml of saline is injected. After observing the spread to the target plane, 20 ml of 0.25% bupivacaine is applied. The same process is repeated bilaterally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparing the numerical rating scale scores
Time Frame: Postoperative 24 hours
Numerical rating scale will be used for pain assessment. The scores of the numerical rating scale changes between 0 to 10 points. 10 points mean "the most severe pain that the patient ever had". 0 point means "there is no pain." Higher scores mean worse outcome.
Postoperative 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparing total morphine consumption
Time Frame: Postoperative 24 hours
Postoperative analgesic need
Postoperative 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cumhuriyet University

Investigators

  • Principal Investigator: Oğuz Gündoğdu, Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 15, 2024

Primary Completion (Estimated)

September 15, 2024

Study Completion (Estimated)

September 20, 2024

Study Registration Dates

First Submitted

August 12, 2024

First Submitted That Met QC Criteria

August 12, 2024

First Posted (Actual)

August 14, 2024

Study Record Updates

Last Update Posted (Actual)

August 14, 2024

Last Update Submitted That Met QC Criteria

August 12, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSB and Recto-İC in sternotomy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Post Operative Pain

Clinical Trials on Parasternal Block and Recto-İntercostal Fascial Plane Block

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe