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

NCT07175298 | Not Yet Recruiting

• 1 other identifier: 0307518
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Postoperative Pain; Cardiac Surgery

Keywords

The Serratus Posterior Superior Intercostal Plane Block

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (6)

• Time to extubation

  post operative 6 hour

• Time to first rescue analgesia

  48hour post operatively

• Postoperative pain intensity

  6, 12, 18,24, 36, and 48 hours post-extubation.

• Patient satisfaction

  at 24 hours post-extubation

• Length of stay

  post operative 5 days

Study Arms (2)

Control Group: PCS fentanyl based

ACTIVE COMPARATOR

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

Procedure: conventional opioid-based technique

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

Procedure: SPSIPB Group

Interventions

conventional opioid-based technique PROCEDURE

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

Control Group: PCS fentanyl based

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

The Serratus Posterior Superior Intercostal Plane Block group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of medicine ,Alexandria university

Alexandria, Alexandria Governorate, 21521, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Islam LECTURER OF ANESTHESIA AND SURGICAL INTENSIVE CARE, Dr

  University of Alexandria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ISLAM ELBARDAN, MD

CONTACT

00201112278083; Islam.elbardan@Alexmed.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: LECTURER OF ANESTHESIA AND SURGICALMINTENSIVE CARE

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 16, 2025
• Study Start: September 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: March 1, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)