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Efficacy of Serratus Posterior Superior Intercostal Plane Block on Post-operative Pain in Cardiac Surgery.

Efficacy of Serratus Posterior Superior Intercostal Plane Block on Post-operative Pain Management in Patients Undergoing Adult Cardiac Surgery. A Randomized Controlled Trial

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07175298
Enrollment
120
Registered
2025-09-16
Start date
2025-09-30
Completion date
2026-03-31
Last updated
2025-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery, Postoperative Pain

Keywords

The Serratus Posterior Superior Intercostal Plane Block

Brief summary

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

PROCEDUREconventional opioid-based technique

Control Group: Participants will receive general anaesthesia with a conventional opioid-based technique

PROCEDURESPSIPB 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

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Total postoperative fentanyl consumptionthe first 24 and 48 hours post-extubation.will be measured as the total amount of fentanyl (in micrograms) consumed via PCA

Secondary

MeasureTime frameDescription
Time to first rescue analgesia48hour post operativelyTime from extubation to the first request for PCA bolus.
Postoperative pain intensity6, 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 to extubationpost operative 6 hourduration (minutes) between ICU admission and endotracheal extubation.
Length of staypost operative 5 daystotal hospital stay (days).
Incidence of adverse28hour postoperative1. Related to local anesthesia toxicity (neurologic or cardiovascular events). 2. Related to block procedure (hematoma and pneumothorax, nerve injury). 3. Related to opioid administration (postoperative nausea and vomiting, dizziness, and pruritus, respiratory depression (respiratory rate \< 10breaths/min or SpO2 \< 90% on room air)).
Patient satisfactionat 24 hours post-extubationAssessed using a 5-point Likert scale ( 1-Very dissatisfied 2-Dissatisfied 3-Neutral 4-Satisfied 5-Very satisfied)

Countries

Egypt

Contacts

Primary ContactISLAM ELBARDAN, MD
Islam.elbardan@Alexmed.edu.eg00201112278083

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026