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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07621744
Enrollment
120
Registered
2026-06-02
Start date
2024-01-01
Completion date
2026-01-12
Last updated
2026-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery, Median Sternotomy, Postoperative Pain

Keywords

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

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.

Detailed description

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.

Interventions

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

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

Sponsors

Ataturk University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Participants and postoperative outcome assessors were blinded to group assignment. In addition, laboratory personnel performing salivary opiorphin measurements were blinded to treatment allocation.

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Salivary Opiorphin LevelBaseline, 3 minutes after sternotomy, and postoperative 6 hoursSalivary opiorphin levels were measured using ELISA to evaluate the analgesic effect of the study interventions.

Secondary

MeasureTime frameDescription
Postoperative Pain Intensity Assessed by the Visual Analogue ScaleAt 1, 2, 4, 8, 12, and 24 hours after extubationPostoperative 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.
Additional Analgesic RequirementWithin the first 24 hours after extubationThe need for rescue analgesia was recorded during the postoperative follow-up period.
Total Opioid ConsumptionWithin the first 24 postoperative hoursTotal opioid consumption delivered by patient-controlled analgesia was recorded.
Extubation TimeImmediately after surgery until tracheal extubation, assessed up to 24 hours postoperativelyTime to extubation was defined as the duration from the end of surgery to tracheal extubation and was recorded in minutes.
Intensive Care Unit Length of StayFrom postoperative intensive care unit admission until intensive care unit discharge, assessed up to 7 days postoperativelyIntensive 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.
Postoperative Nausea and VomitingWithin the first 24 postoperative hoursPostoperative nausea and vomiting were recorded as adverse effects.

Countries

Turkey (Türkiye)

Contacts

STUDY_DIRECTORMuhammed Enes Aydin, professor

Ataturk University Department of Anesthesiology and Reanimation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 3, 2026