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
Not provided
Cardiac surgery, particularly procedures involving median sternotomy, is associated with significant postoperative pain. Acute postoperative pain is severe in cardiac patients undergoing sternotomy, and pain intensity is more severe than expected. Poorly controlled pain after surgery can lead to myocardial ischemia and pulmonary infections.Regional anesthesia techniques offer a promising alternative or adjunct to systemic opioids, providing targeted pain relief with fewer systemic side effects. The Serratus Posterior Superior Intercostal Plane Block (SPSIPB) is a novel regional anesthesia technique that involves injecting local anesthetic into the fascial plane between the serratus posterior superior muscle and the intercostal muscles
Cardiac surgery, particularly procedures involving median sternotomy, is associated with significant postoperative pain. Acute postoperative pain is severe in cardiac patients undergoing sternotomy, and pain intensity is more severe than expected. Poorly controlled pain after surgery can lead to myocardial ischemia and pulmonary infections.
Effective pain management is crucial for patient recovery, reducing complications, and facilitating early mobilization. Opioids are commonly used for postoperative analgesia but are associated with numerous side effects, including respiratory depression, nausea, vomiting, constipation, and prolonged hospitalization.
Regional anesthesia techniques offer a promising alternative or adjunct to systemic opioids, providing targeted pain relief with fewer systemic side effects. The Serratus Posterior Superior Intercostal Plane Block (SPSIPB) is a novel regional anesthesia technique that involves injecting local anesthetic into the fascial plane between the serratus posterior superior muscle and the intercostal muscles. This block will provide analgesia to the anterolateral and posterior chest wall, covering dermatomes relevant to cardiac surgery.
Preliminary case reports and small studies suggest its efficacy in thoracic and cardiac surgeries, demonstrating effective pain control and reduced opioid consumption. However, a randomized controlled trial is necessary to definitively determine the efficacy and safety of SPSIPB as part of multimodal analgesia in adult cardiac surgery.
Fascial plane blocks in regional anesthesia have gained importance in recent years. It involves injection into a tissue plane to provide analgesia and is an alternative to neuraxial and paravertebral techniques. It is often safer and is associated with less cardiorespiratory instability or complications compared to epidural analgesia.
The primary objective of the study is to examine the effect of adding preemptive SPSIPB to general anesthesia in adult cardiac surgery through sternotomy on the postoperative opioid consumption. The secondary objectives will include time to extubation, the intensity of postoperative pain, time to 1st rescue analgesia, patient satisfaction, and any possible side effects of the study drugs and technique.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group: PCS fentanyl based | Active Comparator | Control Group: Participants will receive general anaesthesia with a conventional opioid-based technique(fentanyl) |
|
| The Serratus Posterior Superior Intercostal Plane Block group | Experimental | SPSIPB Group: Participants will receive an ultrasound-guided Serratus posterior superior intercostal plane block with 30 ml 0.25% bupivacaine per side pre-incision and general anaesthesia with opioid based fentanyl |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| conventional opioid-based technique | Procedure | Control Group: Participants will receive general anaesthesia with a conventional opioid-based technique |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total postoperative fentanyl consumption | will be measured as the total amount of fentanyl (in micrograms) consumed via PCA | the first 24 and 48 hours post-extubation. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to extubation | duration (minutes) between ICU admission and endotracheal extubation. | post operative 6 hour |
| Time to first rescue analgesia | Time from extubation to the first request for PCA bolus. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ISLAM ELBARDAN, MD | Contact | 00201112278083 | Islam.elbardan@Alexmed.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Islam LECTURER OF ANESTHESIA AND SURGICAL INTENSIVE CARE, Dr | University of Alexandria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of medicine ,Alexandria university | Alexandria | Alexandria Governorate | 21521 | Egypt |
Not provided
Not provided
Not provided
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
| SPSIPB Group | Procedure | SPSIPB Group: Participants will receive an ultrasound-guided Serratus posterior superior intercostal plane block with 30 ml 0.25% bupivacaine per side pre-incision and general anaesthesia with opioid based fentanyl |
|
| 48hour post operatively |
| Postoperative pain intensity | Assessed using the Critical-Care Pain Observation Tool (CPOT) during intubation and the Numerical Rating Scale (NRS), at 6, 12, 18,24, 36, and 48 hours post-extubation. The CPOT ranges from 0 to 8, and the NRS ranges from 0 (no pain) to 10 (worst possible pain). | 6, 12, 18,24, 36, and 48 hours post-extubation. |
| Patient satisfaction | Assessed using a 5-point Likert scale ( 1-Very dissatisfied 2-Dissatisfied 3-Neutral 4-Satisfied 5-Very satisfied) | at 24 hours post-extubation |
| Length of stay | total hospital stay (days). | post operative 5 days |
| Incidence of adverse |
| 28hour postoperative |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |