NCT06553560

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 14, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

August 15, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2024

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2024

Completed
Last Updated

August 14, 2024

Status Verified

August 1, 2024

Enrollment Period

1 month

First QC Date

August 12, 2024

Last Update Submit

August 12, 2024

Conditions

Keywords

sternotomycardiac surgeryparasternal blockrecto-intercostal fascial plane blockpostoperative painregional anesthesia

Outcome Measures

Primary Outcomes (1)

  • Comparing the numerical rating scale scores

    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 Outcomes (1)

  • Comparing total morphine consumption

    Postoperative 24 hours

Study Arms (1)

Parasternal Block and Recto-İntercostal Fascial Plane Block

OTHER

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

Interventions

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.

Parasternal Block and Recto-İntercostal Fascial Plane Block

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Oğuz Gündoğdu

    Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 12, 2024

First Posted

August 14, 2024

Study Start

August 15, 2024

Primary Completion

September 15, 2024

Study Completion

September 20, 2024

Last Updated

August 14, 2024

Record last verified: 2024-08