Additive Regional Fascial Plain Blocks to Pectointercostal Fascial Block for Postoperative Pain Management After Cardiac Surgery: a Randomized Controlled Trial

NCT06865404 | Completed

• 1 other identifier: IRP 00012098
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Acute postoperative pain is severe in cardiac patients undergoing sternotomy, and pain intensity is more severe than expected. Many patients referred to tube insertion as the most painful site after coronary artery bypass surgery. (6) Rectus sheath block (RSB) can offer somatic analgesia for midline incisions. (7) It has been verified to manage subxiphoid drainage pain effectively and safely for cardiac surgery patients. Another intervention, External oblique intercoastal plane block (EOIPB) is given at the mid-clavicular line and may block the intercostal nerve's anterior and lateral branches. Anesthesia is provided between the external oblique and intercostal nerves. This allows analgesia of the anterior upper abdominal wall between T6-T10 dermatomes in the anterior axillary line and T6-T9 dermatomes in the midline. It blocks the lateral and anterior branches of T6-T10 intercostal nerves.

Conditions

Postoperative Pain Management

Keywords

pain; sternotomy; cardiac surgery

Outcome Measures

Primary Outcomes (1)

• To compare the incidence of epigastric drain site pain after ultrasound-guided bilateral PIFPB, PIPRSB, and PIEOB for acute postoperative pain after sternotomy in adult cardiac surgery patients

  Incidence of non-sternal wound pain by asking the patients about the site of pain. Is it at the sternal wound or the epigastric drain?

  24 hours postoperatively

Secondary Outcomes (6)

• Recording intravenous opioid consumption 24 hours after ICU admission

  24 hours postoperatively

• Time to extubation

  24 hours postoperatively

• the intensity of postoperative pain & time to 1st rescue analgesia

  24 hours postoperatively

• possible side effects of the study drugs and technique.

  24 hours postoperatively

• The incidence of pethidine rescue analgesia

  24 hours post- extubation.

Study Arms (3)

Pecto-Intercostal Fascial Plane Block technique

EXPERIMENTAL

The ultrasound probe will be positioned parallel and 2-3 cm lateral from the midline in the 4th or 5th intercostal space. The needle will be inserted in-plane in a cauda-cranial direction until the tip of the needle reaches the plane of the fascia between the pectoralis major muscle and the external intercostal muscles. A 20 ml volume of bupivacaine 0.25% will be injected on each side.

Procedure: PIFPB block

Pecto-Intercostal Rectus Sheath Fascial Plane Block technique (14)

ACTIVE COMPARATOR

After the PIFPB is performed with the same position and probe, a bilateral posterior rectus sheath block (PRSB) will be conducted. The probe will be placed 2-3 cm next to the xiphoid in the epigastric region and parallel to the costal margin. The needle will be inserted into the plane between the rectus abdominal muscle and its posterior sheath. After verifying needle placement, 10 ml of bupivacaine 0.25% will be injected on each side.

Procedure: PIRSB Block

Pecto-intercostal facial plane with an external oblique intercostal block

ACTIVE COMPARATOR

After the PIFPB is performed with the same position and probe, an external oblique block will be used to place the linear array ultrasound probe between the midclavicular line and the anterior axillary line at the level of the 6th rib, with the direction mark pointing to the cephalad. The probe will be rotated on the slightly medial cranial end, and the caudal end will be lateral to produce a mesial sagittal oblique view and a short-axis view of the ribs. The following structures will be identified from superficial to deep layers: subcutaneous tissue, external oblique muscle, intercostal muscles, pleura, and lung. After determining the thoracic fascial space between the external oblique muscle and the intercostal muscles, bupivacaine 20 mL will be slowly injected into the space with a nerve block needle at the head side of the 6th rib horizontally near the mid axillary line. The block will be repeated

Interventions

PIFPB block PROCEDURE

The ultrasound probe will be positioned parallel and 2-3 cm lateral from the midline in the 4th or 5th intercostal space. The needle will be inserted in-plane in a cauda-cranial direction until the tip of the needle reaches the plane of the fascia between the pectoralis major muscle and the external intercostal muscles. A 20 ml volume of bupivacaine 0.25% will be injected on each side.

Pecto-Intercostal Fascial Plane Block technique

PIRSB Block PROCEDURE

After the PIFPB is performed with the same position and probe, a bilateral posterior rectus sheath block (PRSB) will be conducted. The probe will be placed 2-3 cm next to the xiphoid in the epigastric region and parallel to the costal margin. The needle will be inserted into the plane between the rectus abdominal muscle and its posterior sheath. After verifying needle placement, 10 ml of bupivacaine 0.25% will be injected on each side.

Pecto-Intercostal Rectus Sheath Fascial Plane Block technique (14)

PIEOB block PROCEDURE

After the PIFPB is performed with the same position and probe, an external oblique block will be used to place the linear array ultrasound probe between the midclavicular line and the anterior axillary line at the level of the 6th rib, with the direction mark pointing to the cephalad. The probe will be rotated on the slightly medial cranial end, and the caudal end will be lateral to produce a mesial sagittal oblique view and a short-axis view of the ribs. The following structures will be identified from superficial to deep layers: subcutaneous tissue, external oblique muscle, intercostal muscles, pleura, and lung. After determining the thoracic fascial space between the external oblique muscle and the intercostal muscles, bupivacaine 20 mL will be slowly injected into the space with a nerve block needle at the head side of the 6th rib horizontally near the mid axillary line. The block will be repeated in the same way on the other side.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The study will include adult patients of both sexes, aged 18 to 65, with American Society of Anesthesiologists (ASA) physical status II and III who are scheduled to have fast-tracking elective on-pump cardiac surgery through a median sternotomy with epigastric drain insertion.

You may not qualify if:

• patients who refused to participate in the study, also
• who had Cognitive impairment or mental disorders,
• Ages \<18 and \>65 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 and
• patients undergoing emergency procedures
• patients with a history of substance abuse.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria University

Alexandria, Alexandria Governorate, 21521, Egypt

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Islam Elbardan, Dr

  University of Alexandria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 7, 2025
• Study Start: March 4, 2025
• Primary Completion: August 30, 2025
• Study Completion: August 30, 2025
• Last Updated: April 22, 2026

Record last verified: 2025-02

Locations

EG (1)