Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This randomized controlled trial aims to compare the analgesic efficacy of parasternal intercostal plane block (PIPB) alone versus the combination of parasternal intercostal plane block and serratus anterior plane block (SAPB) in adult patients undergoing elective cardiac surgery via sternotomy. Seventy patients will be randomly assigned to two groups: Group A will receive bilateral PIPB, while Group B will receive bilateral PIPB combined with unilateral SAPB on the side of chest drain placement. Postoperative pain will be assessed using the visual analog scale (VAS) at rest and during movement over the first 24 hours. Secondary outcomes include time to extubation, length of stay in the intensive care unit, and time to mobilization. The study is designed as a prospective, single-center, single-blind trial conducted at Akdeniz University Hospital, Antalya, Turkey. We hypothesize that the combined block technique will provide superior analgesia, reduce opioid consumption, and improve recovery parameters compared to PIPB alone
Poststernotomy pain after cardiac surgery is a major clinical concern, often leading to impaired respiratory function, limited mobilization, and prolonged intensive care unit (ICU) stay. Although opioids are traditionally used as the mainstay of postoperative analgesia, their side effects-including respiratory depression, nausea, constipation, and delirium-limit their optimal use. Therefore, regional anesthesia techniques that reduce opioid consumption have gained increasing importance in cardiac anesthesia practice.
The parasternal intercostal plane block (PIPB) targets the anterior branches of the thoracic intercostal nerves and has been shown to provide effective analgesia around the sternotomy site. However, PIPB alone may be insufficient for controlling pain originating from lateral chest wall regions, particularly at chest drain insertion sites, which are innervated by the lateral cutaneous branches of the intercostal nerves. To address this limitation, the serratus anterior plane block (SAPB) has been proposed, as it effectively blocks the lateral thoracic dermatomes and thus may provide broader postoperative pain coverage.
This prospective, randomized, single-blind clinical trial is designed to compare the analgesic efficacy of bilateral PIPB alone versus bilateral PIPB combined with unilateral SAPB in adult patients undergoing elective cardiac surgery via sternotomy. A total of 70 patients will be randomly allocated into two groups: Group A will receive bilateral PIPB with standard intravenous morphine, while Group B will receive bilateral PIPB plus unilateral SAPB on the side of chest drain placement. Blocks will be performed under ultrasound guidance using bupivacaine at safe dose limits.
The primary outcome is postoperative pain intensity assessed by the visual analog scale (VAS) at rest and during coughing/movement within the first 24 hours. Secondary outcomes include time to extubation, ICU length of stay, and time to first mobilization. Additional endpoints are rescue opioid requirements and total analgesic consumption within the first 24 hours. We hypothesize that the combined PIPB + SAPB technique will provide superior analgesia, reduce opioid use, and enhance recovery parameters compared with PIPB alone.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parasternal Intercostal Plane Block | Experimental | Patients will receive bilateral parasternal intercostal plane block with bupivacaine under ultrasound guidance, plus standard intravenous morphine at the end of surgery. |
|
| Parasternal + Serratus Plane Block | Experimental | Patients will receive bilateral parasternal intercostal plane block combined with unilateral serratus anterior plane block (on the chest drain side), using bupivacaine under ultrasound guidance. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parasternal Intercostal Plane Block | Procedure | Bilateral parasternal intercostal plane block will be performed under ultrasound guidance at the 3rd and 5th intercostal spaces using 0.25% bupivacaine (total 30 mL). At the end of surgery, intravenous morphine (0.1 mg/kg) will be administered. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain intensity (VAS) | Pain intensity measured using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. | 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Time to extubation | The duration (in minutes) from the end of surgery to successful extubation. | Postoperative period until extubation. |
| Length of stay in the intensive care unit (ICU) | Duration of ICU stay measured from admission to the intensive care unit after surgery until transfer to the hospital ward. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of rescue opioid administrations | Total number of rescue opioid administrations required for postoperative analgesia. | Within the first 24 hours after surgery |
| Total dose of rescue opioids | Total cumulative dose of rescue opioids administered for postoperative analgesia. |
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| BEDİA MİNE HANEDAN | Konya şehir hastanesi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SBÜ Konya Şehir Hastanesi | Konya | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10936140 | Background | Kuwano K, Kawasaki M, Maeyama T, Hagimoto N, Nakamura N, Shirakawa K, Hara N. Soluble form of fas and fas ligand in BAL fluid from patients with pulmonary fibrosis and bronchiolitis obliterans organizing pneumonia. Chest. 2000 Aug;118(2):451-8. doi: 10.1378/chest.118.2.451. | |
| 33461569 | Background | Servidio AG, Capata G, Levantino L, Riccio G, Contorno S, Barbi E, Maschio M. COVID-19 lockdown beneficial effects on lung function in a cohort of cystic fibrosis patients. Ital J Pediatr. 2021 Jan 18;47(1):12. doi: 10.1186/s13052-021-00970-4. No abstract available. |
Not provided
Not provided
The investigators have not yet determined whether individual participant data (IPD) will be shared. If sharing is pursued, de-identified data related to postoperative pain scores, opioid consumption, and recovery parameters may be made available to qualified researchers upon reasonable request after the main results are published.
6 month
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Parasternal Intercostal Plane Block + Serratus Anterior Plane Block | Procedure | Bilateral parasternal intercostal plane block will be performed as in Arm 1. In addition, a unilateral serratus anterior plane block will be performed under ultrasound guidance at the 4th-6th intercostal level on the side of chest drain placement, with 0.25% bupivacaine (5-7 mL per injection site, not exceeding 2.5 mg/kg). |
|
| From ICU admission after surgery until ICU discharge, up to 30 days |
| Time to first mobilization | Time from admission to the intensive care unit after surgery until the first documented patient mobilization attempt. | From ICU admission after surgery until the first mobilization attempt, assessed up to 30 days |
| Within the first 24 hours after surgery |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |