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

NCT07621744 | Completed

• 2 other identifiers: B.30.2.ATA.0.01.00/3532023/2
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain; Cardiac Surgery; Median Sternotomy

Keywords

Parasternal Block; Wound Site Infiltration; Opiorphin; Median Sternotomy; Postoperative Analgesia

Outcome Measures

Primary Outcomes (1)

• Change in Salivary Opiorphin Level

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

  Baseline, 3 minutes after sternotomy, and postoperative 6 hours

Secondary Outcomes (6)

• Postoperative Pain Intensity Assessed by the Visual Analogue Scale

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

• Additional Analgesic Requirement

  Within the first 24 hours after extubation

• Total Opioid Consumption

  Within the first 24 postoperative hours

• Extubation Time

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

• Intensive Care Unit Length of Stay

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

Study Arms (3)

Parasternal Block Group

EXPERIMENTAL

Participants in this group received ultrasound-guided parasternal block with local anesthetic before surgical incision, in addition to standard perioperative systemic analgesia.

Procedure: Parasternal blocks

Wound Site Infiltration Group

ACTIVE COMPARATOR

Participants in this group received wound site infiltration with local anesthetic before surgical incision, in addition to standard perioperative systemic analgesia.

Procedure: Wound Site Infiltration

Standard Analgesia Group

NO INTERVENTION

Participants in this group received standard perioperative systemic analgesia without local anesthetic intervention at the surgical site.

Interventions

Parasternal blocks PROCEDURE

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

Parasternal Block Group

Wound Site Infiltration PROCEDURE

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

Wound Site Infiltration Group

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University

Erzurum, 25240, Turkey (Türkiye)

Location

Related Publications (4)

• Parida SK, Guruprasad T, Krishnakumar VB, Ravi RP. A study of salivary opiorphin levels using different anesthetic drugs and techniques - A randomized controlled clinical study. J Stomatol Oral Maxillofac Surg. 2018 Jun;119(3):169-171. doi: 10.1016/j.jormas.2017.11.017. Epub 2017 Dec 13.

  PMID: 29247820 BACKGROUND

• Ozdogan MS, Gungormus M, Ince Yusufoglu S, Ertem SY, Sonmez C, Orhan M. Salivary opiorphin in dental pain: A potential biomarker for dental disease. Arch Oral Biol. 2019 Mar;99:15-21. doi: 10.1016/j.archoralbio.2018.12.006. Epub 2018 Dec 15.

  PMID: 30590229 BACKGROUND

• Gavcar EG, Kabukcu Basay B, Avci E, Basay O. Relationship between saliva opiorphin levels, pain threshold, and cutting number in adolescents with non suicidal self injury. J Psychiatr Res. 2022 Jul;151:611-618. doi: 10.1016/j.jpsychires.2022.05.030. Epub 2022 May 24.

  PMID: 35636040 BACKGROUND

• Yilmaz N, Baygin O, Tuzuner T, Mentese A, Demir S. Determination of the effect of two different methods of dental anesthesia on pain level in pediatric patients: A cross-over, randomized trial. Niger J Clin Pract. 2022 Nov;25(11):1853-1863. doi: 10.4103/njcp.njcp_289_22.

  PMID: 36412293 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Muhammed Enes Aydin, professor

  Ataturk University Department of Anesthesiology and Reanimation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and postoperative outcome assessors were blinded to group assignment. In addition, laboratory personnel performing salivary opiorphin measurements were blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants were assigned to one of three parallel groups: parasternal block, wound site infiltration, or standard systemic analgesia.

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 2, 2026
• Study Start: January 1, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 12, 2026
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)