Comparison of Paravertebral Block and Deep Parasternal Intercostal Plane Block in Cardiac Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGaziantep City Hospital

About this trial

Median sternotomy is commonly used in cardiac surgery and is often associated with significant postoperative pain. Poor pain control after sternotomy may increase opioid use, delay mobilization, prolong extubation time, and contribute to respiratory complications and longer hospital stay. Regional analgesia techniques may help improve pain management and reduce opioid requirements after surgery.

This study is a prospective, randomized, single-center clinical trial that will compare two ultrasound-guided regional analgesia techniques in adult patients undergoing elective cardiac surgery through median sternotomy: thoracic paravertebral block and bilateral deep parasternal intercostal plane block. A total of 80 patients will be randomly assigned in a 1:1 ratio to receive one of these two blocks in addition to standard general anesthesia and routine multimodal analgesia.

The main objective of the study is to compare the effects of these two techniques on total opioid consumption during the first 24 hours after surgery. Secondary outcomes include postoperative pain scores, need for additional analgesics, analgesia-related side effects such as nausea, vomiting, or respiratory depression, and extubation time. Pain will be assessed using a visual analog scale at predefined time points during the first 24 postoperative hours.

The study hypothesis is that there will be a clinically meaningful difference in postoperative analgesic effectiveness between thoracic paravertebral block and bilateral deep parasternal intercostal plane block in patients undergoing cardiac surgery via median sternotomy. The results of this study may help guide the selection of the most appropriate regional analgesia technique for pain control after sternotomy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Thoracic paravertebral block (TPVB)

    Procedure/Surgery

    Ultrasound-guided thoracic paravertebral block performed before elective cardiac surgery via median sternotomy, in addition to standard general anesthesia and routine multimodal analgesia.

  • Bilateral Deep Parasternal Intercostal Plane Block

    Procedure/Surgery

    Ultrasound-guided bilateral deep parasternal intercostal plane block performed before elective cardiac surgery via median sternotomy, in addition to standard general anesthesia and routine multimodal analgesia.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Thoracic Paravertebral Block GroupActive comparator 1 intervention
Group B: Bilateral Deep Parasternal Intercostal Plane Block GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Total Opioid Consumption in the First 24 Hours After Surgery

Total opioid consumption during the first 24 postoperative hours will be recorded and compared between the two groups.

Time frame
First 24 hours after surgery

Secondary outcomes

1

Postoperative Pain Scores Assessed by Visual Analog Scale

Postoperative pain intensity will be assessed using the Visual Analog Scale at predefined postoperative time points and compared between groups.

Time frame
0, 2, 4, 6, 12, and 24 hours after surgery
2

Additional Analgesic Requirement

The need for rescue or additional analgesic medication during the first 24 postoperative hours will be recorded and compared between groups.

Time frame
First 24 hours after surgery
3

Analgesia-Related Adverse Effects

Analgesia-related adverse effects, including nausea, vomiting, and respiratory depression, will be recorded and compared between groups.

Time frame
First 24 hours after surgery
4

Extubation Time

Time from the end of surgery to extubation will be recorded and compared between groups.

Time frame
During the postoperative period, up to 24 hours after surgery

Other outcomes

Sponsors and contacts

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