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

NCT ID: NCT07175298

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2026-03-31

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.

Conditions

Postoperative Pain; Cardiac Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Control Group: PCS fentanyl based

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

Group Type: ACTIVE_COMPARATOR

conventional opioid-based technique

Intervention Type: PROCEDURE

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

The Serratus Posterior Superior Intercostal Plane Block 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

Group Type: EXPERIMENTAL

SPSIPB Group

Intervention Type: 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

Interventions

conventional opioid-based technique

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

Intervention Type: 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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Islam Elbardan

LECTURER OF ANESTHESIA AND SURGICALMINTENSIVE CARE

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Islam LECTURER OF ANESTHESIA AND SURGICAL INTENSIVE CARE, Dr

Role: PRINCIPAL_INVESTIGATOR

University of Alexandria

Locations

Faculty of medicine ,Alexandria university

Alexandria, Alexandria Governorate, Egypt

Countries

Egypt

Central Contacts

ISLAM ELBARDAN, MD

Role: CONTACT

Islam.elbardan@Alexmed.edu.eg

00201112278083

Facility Contacts

Hesham ELgoweini, Prof.Dr.

Role: primary

ethics.comm@alexmed.edu.eg

00201287740750

Other Identifiers

0307518

Identifier Type: -

Identifier Source: org_study_id