Skip to main content
OpenTrials
Completed

NCT Number: NCT07621744

Parasternal Block Versus Wound Infiltration for Pain After Median Sternotomy:A Salivary Opiorphin-Based Study

This study evaluated the effects of parasternal block and wound site infiltration on postoperative pain in patients undergoing median sternotomy. Patients were allocated to receive parasternal block, wound site infiltration, or standard systemic analgesia. Salivary opiorphin levels and postoperative pain scores were assessed to compare analgesic effectiveness between the groups.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postoperative Pain Cardiac Surgery Median Sternotomy Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ataturk University

Erzurum, 25240, Turkey (Türkiye)

About this study

This randomized prospective study included patients undergoing surgery through median sternotomy. The study compared three perioperative analgesic approaches: parasternal block, wound site infiltration, and standard systemic analgesia without local intervention at the surgical site.

Salivary samples were collected before surgery, after sternotomy, and during the postoperative period to measure opiorphin levels. Postoperative pain was assessed using visual analogue scale scores, and additional analgesic requirement, opioid consumption, extubation time, intensive care unit stay, and adverse effects such as nausea and vomiting were recorded.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients scheduled for surgery through median sternotomy
  • Patients who provided informed consent

Exclusion criteria

  • Age under 30 years
  • Presence of ischemic, inflammatory, or systemic disease, except cardiovascular disease
  • Use of analgesic medication within the last 24 hours
  • Diagnosis of psychiatric disorder
  • Presence of any oral pathology, including active dental caries, aphthous lesions, or salivary gland inflammation
  • Prolonged intubation or inability to be separated from mechanical ventilation for more than 8 hours

Treatment and study plan

Parasternal blocks

Procedure

Ultrasound-guided parasternal block was performed with local anesthetic before surgical incision.

Wound Site Infiltration

Procedure

Local anesthetic infiltration was performed at the surgical wound site before surgical incision.

Primary outcomes

  1. Change in Salivary Opiorphin Level

    Time frame: Baseline, 3 minutes after sternotomy, and postoperative 6 hours

    Salivary opiorphin levels were measured using ELISA to evaluate the analgesic effect of the study interventions.

Secondary outcomes

  1. Postoperative Pain Intensity Assessed by the Visual Analogue Scale

    Time frame: At 1, 2, 4, 8, 12, and 24 hours after extubation

    Postoperative pain intensity was assessed using the Visual Analogue Scale. The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse postoperative pain.

  2. Additional Analgesic Requirement

    Time frame: Within the first 24 hours after extubation

    The need for rescue analgesia was recorded during the postoperative follow-up period.

  3. Total Opioid Consumption

    Time frame: Within the first 24 postoperative hours

    Total opioid consumption delivered by patient-controlled analgesia was recorded.

  4. Extubation Time

    Time frame: Immediately after surgery until tracheal extubation, assessed up to 24 hours postoperatively

    Time to extubation was defined as the duration from the end of surgery to tracheal extubation and was recorded in minutes.

  5. Intensive Care Unit Length of Stay

    Time frame: From postoperative intensive care unit admission until intensive care unit discharge, assessed up to 7 days postoperatively

    Intensive care unit length of stay was defined as the duration from admission to the intensive care unit after surgery until discharge from the intensive care unit and was recorded in hours.

  6. Postoperative Nausea and Vomiting

    Time frame: Within the first 24 postoperative hours

    Postoperative nausea and vomiting were recorded as adverse effects.

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

Determination of the Effect of Parasternal Block Versus Wound Site Infiltration on Postoperative Pain Levels by Salivary Opiorphin Levels in Patients Undergoing Median Sternotomy: A Randomized Prospective Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 2, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.