NCT06558123

Brief Summary

In this study, we aimed to compare the effects of this block, which is routinely applied in our hospital but has not been studied in our hospital or in the literature before, on the pain in the first 24 hours after the operation, between the single-level and the two-level block.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 14, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

August 15, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 16, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

4 months

First QC Date

August 14, 2024

Last Update Submit

December 24, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • numeric rating scale

    24 hours pain

    4 month

Study Arms (2)

Control

single level

Procedure: block

study

two level

Procedure: block

Interventions

blockPROCEDURE

Single Level and Two Level Deep Parasternal Intercostal Plane (DPIP) Block

Controlstudy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients over the age of 18 who will undergo sternotomy

You may qualify if:

  • Adult patients aged 18 years and older
  • American Society of Anesthesiologists physical status of II-III
  • Undergoing elective coronary artery bypass grafting (CABG), valve repair/replacement, or combined CABG/valve procedure via median sternotomy

You may not qualify if:

  • Patients who are unable to communicate
  • Patients who have had emergency surgery, reoperation, thoracotomy or mastectomy
  • Patients with a history of chronic pain
  • Patients who are using chronic opioids or sedatives
  • Patients who have had a re-sternotomy within 24 hours of surgery
  • Patients with liver or kidney failure
  • Patients who are using narcotics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istinye Üniversity

Istanbul, Merkez Mahallesi, 34250, Turkey (Türkiye)

Location

Related Publications (3)

  • Zhang Y, Min J, Chen S. Sensory Assessment and Block Duration of Deep Parasternal Intercostal Plane Block in Patients Undergoing Cardiac Surgery: A Prospective Observational Study. Pain Ther. 2022 Sep;11(3):951-958. doi: 10.1007/s40122-022-00403-y. Epub 2022 Jun 25.

    PMID: 35751781BACKGROUND
  • 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.

  • Gelinas C. Management of pain in cardiac surgery ICU patients: have we improved over time? Intensive Crit Care Nurs. 2007 Oct;23(5):298-303. doi: 10.1016/j.iccn.2007.03.002. Epub 2007 Apr 19.

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. prof

Study Record Dates

First Submitted

August 14, 2024

First Posted

August 16, 2024

Study Start

August 15, 2024

Primary Completion

December 15, 2024

Study Completion

December 20, 2024

Last Updated

December 27, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations