Clinical Trial on Postoperative Pain, Extubation Time - Clinical Trials Registry

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

"Median sternotomy performed in open-heart surgery causes severe anterior chest wall pain in the postoperative period. This pain leads to inadequate inspiration, suppression of the cough reflex, atelectasis, and increased pulmonary complications. On the other hand, traditionally used high-dose opioid-based analgesia regimens delay the extubation process by causing respiratory depression, nausea, sedation, and impaired intestinal motility.

In current cardiac anesthesia practice, the primary goal is to reduce opioid consumption through multimodal analgesia approaches, enable early extubation (fast-track cardiac anesthesia), and shorten the duration of intensive care unit stay.

Median sternotomy performed in open-heart surgery causes severe anterior chest wall pain in the postoperative period. This pain leads to inadequate inspiration, suppression of the cough reflex, atelectasis, and an increase in pulmonary complications. On the other hand, traditionally used high-dose opioid-based analgesia regimens delay the extubation process by causing respiratory depression, nausea, sedation, and gastrointestinal motility disorders.

In current cardiac anesthesia practice, the primary goal is to reduce opioid consumption through multimodal analgesia approaches, enable early extubation (fast-track cardiac anesthesia), and shorten the length of stay in the intensive care unit.

Parasternal block (parasternal intercostal block or pectoral/parasternal fascial plane blocks) targets the anterior cutaneous branches of T2-T6 spinal nerves, providing potent analgesia around the sternum and internal mammary area. Studies in the literature demonstrate that bilateral parasternal block performed under ultrasonography (USG) guidance significantly controls somatic pain related to sternotomy incision.

Rectointercostal fascial plane block blocks the anterior and lateral cutaneous branches of T6-T9 intercostal nerves. It provides somatic analgesia in the epigastric region, subxiphoid incision lines, and the lower border of the anterior abdominal/chest wall. It specifically blocks the sharp pain at the subxiphoid chest tube (drain) insertion sites-which are not covered by the parasternal block applied for median sternotomy in open-heart surgery-and the discomfort during tube removal.

Opioid Sparing and Pulmonary Functions: Randomized controlled trials have reported that blocks administered intraoperatively or at the end of surgery reduce total postoperative 24-hour opioid (fentanyl, morphine, tramadol) consumption by 30% to 50%. Decreased opioid requirement improves the recovery quality of patients by minimizing systemic side effects.

Extubation Time: Optimization of analgesia ensures the maintenance of patient chest wall compliance and tidal volume. Literature shows that patients receiving blocks reach weaning criteria faster once normothermia and hemodynamic stability are achieved, and their mean extubation times are significantly shorter compared to control groups.

Although prospective studies exist in the literature, retrospective cohort analyses investigating the impact of clinical routine practice on extubation times and reflecting real-world data are needed.

For this purpose, patients who underwent open-heart surgery in our clinic during a 2-year period (2024-2025) will be screened to investigate the effect of block applications on extubation times.

"Patients' age, sex, BMI, presence of comorbidities, ejection fraction, duration of surgery, cardiopulmonary bypass time, cross-clamp time, extubation time, administration of rescue analgesia, Visual Analog Scale (VAS) score at extubation, EuroSCORE II, and length of intensive care unit (ICU) stay will be recorded.

The primary endpoint was determined as meeting the weaning criteria and achieving successful extubation.

The secondary endpoint was determined as discharge from the intensive care unit

Study Type

Observational

Enrollment (Estimated)

40

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

Name: GÖKÇE ÜLTAN ÖZGEN
Phone Number: 05067750245
Email: gokceozgen55@gmail.com

Study Locations

Turkey (Türkiye)
- - Samsun, Turkey (Türkiye)
    - Samsun City Hospital
    - Contact:
      
      mehmet gökhan taflan
      
      Phone Number: 05352114070
      
      Email: drmehmettaflan@gmail.com

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

Child
Adult
Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

"Patients who underwent open-heart surgery in our clinic during the period of 2024-2025

Description

Inclusion Criteria:

Patients undergoing elective CABG or valve surgery
Patients with median sternotomy and chest tube/drain placement
Patients with complete anesthesia and intensive care unit follow-up records

Exclusion Criteria:

Patients undergoing emergency surgery or reoperation
Patients who could not be extubated for more than 24 hours
Patients with missing medical record or follow-up data

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

Observational Models: COHORT
Time Perspectives: RETROSPECTIVE

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
NERVE BLOCK GROUP "Patients who underwent ultrasound-guided parasternal and rectointercostal block for postoperative analgesia.
Standard Analgesia Group "Patients followed up with routine postoperative analgesics without receiving any nerve block."

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
POSTOPERATİVE EXTUBATİON TİME Time Frame: Within the first 24-48 hours postoperatively	The primary result measure is the extubation period recorded as the time from the patient's arrival at the intensive care unit to successful extubation.	Within the first 24-48 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS) Pain Score at 30 Minutes Post-Extubation Time Frame: postoperative 30th minute	"Assessment of postoperative pain intensity using the Visual Analog Scale (ranging from 0 to 10) 30 minutes following tracheal extubation	postoperative 30th minute
Visual Analog Scale (VAS) Pain Score at 2 Hours Post-Extubation Time Frame: postoperative 2nd hour	Assessment of postoperative pain intensity using the Visual Analog Scale (ranging from 0 to 10) 2 hours following tracheal extubation.	postoperative 2nd hour

Collaborators and Investigators

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

Sponsor

Samsun University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 26, 2026

Primary Completion (Estimated)

November 2, 2026

Study Completion (Estimated)

November 10, 2026

Study Registration Dates

First Submitted

October 24, 2026

First Submitted That Met QC Criteria

October 31, 2026

First Posted (Actual)

November 4, 2026

Study Record Updates

Last Update Posted (Actual)