Efficacy of Serratus Posterior Superior Intercostal Plane Block on Post-operative Pain in Cardiac Surgery.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: conventional opioid-based technique, SPSIPB Group.
- Who it may be relevant to
- Registry conditions: Postoperative Pain, Cardiac Surgery. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Serratus Posterior Superior Intercostal Plane Block on Post-operative Pain Management in Patients Undergoing Adult Cardiac Surgery. A Randomized Controlled Trial
Overview
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
Detailed description
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.
Interventions
- Procedure conventional opioid-based technique
Control Group: Participants will receive general anaesthesia with a conventional opioid-based technique - Procedure SPSIPB Group
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
Primary outcome measures
- Total postoperative fentanyl consumption [Time frame: the first 24 and 48 hours post-extubation.]
Secondary outcome measures (6)
- Time to extubation [Time frame: post operative 6 hour]
- Time to first rescue analgesia [Time frame: 48hour post operatively]
- Postoperative pain intensity [Time frame: 6, 12, 18,24, 36, and 48 hours post-extubation.]
- Patient satisfaction [Time frame: at 24 hours post-extubation]
- Length of stay [Time frame: post operative 5 days]
- Incidence of adverse [Time frame: 28hour postoperative]
Eligibility criteria
Inclusion criteria
- aged 18 to 60
- both sexes
- who are scheduled to have fast-tracking elective on-pump cardiac surgery through a median sternotomy,
- American Society of Anesthesiologists Physical status II-III,
- Ability to understand and provide informed consent
Exclusion criteria
- patients who refused to participate in the study,
- who had Cognitive impairment or mental disorders,
- Ages <18 and >60 years,
- BMI <18 and >35,
- patients with puncture site infection,
- patients who documented allergy to local anesthetic drugs,
- patients used to take chronic pain medications, patients who made previous sternotomy or chest surgery
- patients with a history of substance abuse.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Faculty of medicine ,Alexandria university — Alexandria
Identifiers
NCT: NCT07175298 · 0307518