Faculty of medicine ,Alexandria university
Alexandria, Alexandria Governorate, 21521, Egypt
Location contact
Hesham ELgoweini, Prof.Dr.
CONTACT
Islam LECTURER OF ANESTHESIA AND SURGICAL INTENSIVE CARE, Dr
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07175298
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
Trial opening soon.
Get Notified18 year–60 year
All sexes
Interventional
Not applicable
Alexandria, Alexandria Governorate, 21521, Egypt
Hesham ELgoweini, Prof.Dr.
CONTACT
Islam LECTURER OF ANESTHESIA AND SURGICAL INTENSIVE CARE, Dr
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Control Group: Participants will receive general anaesthesia with a conventional opioid-based technique
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
Time frame: the first 24 and 48 hours post-extubation.
will be measured as the total amount of fentanyl (in micrograms) consumed via PCA
Time frame: post operative 6 hour
duration (minutes) between ICU admission and endotracheal extubation.
Time frame: 48hour post operatively
Time from extubation to the first request for PCA bolus.
Time frame: 6, 12, 18,24, 36, and 48 hours post-extubation.
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).
Time frame: at 24 hours post-extubation
Assessed using a 5-point Likert scale ( 1-Very dissatisfied 2-Dissatisfied 3-Neutral 4-Satisfied 5-Very satisfied)
Time frame: post operative 5 days
total hospital stay (days).
Time frame: 28hour postoperative
Contact information is provided by the study sponsor or research team.
Alexandria University
Other
Efficacy of Serratus Posterior Superior Intercostal Plane Block on Post-operative Pain Management in Patients Undergoing Adult Cardiac Surgery. A Randomized Controlled Trial
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