Pectointercostal Fascial Plane Block Chronic Pain Sternotomy

NCT06210126 | Completed

• 1 other identifier: 12-31
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the effect of pectointercostal fascial plane block (PIFB) on postoperative chronic pain in patients undergoing open heart surgery with the standard multimodal analgesia technique.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• chronic pain

  Postoperative chronic pain will be evaluated using brief pain inventory at 3 months after cardiac surgery. Brief Pain Inventory is a questionnaire designed to capture both pain intensity and the amount of interference that pain has on functioning. Pain intensity is measured with four items (worst, least, on average, and currently). Interference is measured with seven items, including general activity, mood, walking, work (including paid and household work), relations with others, sleep, and enjoyment of life. The patient answers the items on a scale of 0-10, the highest number indicating the worst imaginable pain for intensity items and complete interference for interference items.

  3 months

Secondary Outcomes (5)

• Time to extubation

  24 hour

• Postoperative pain score

  72 hour

• Postoperative nausea and vomiting (PONV)

  72 hour

• Length of stay in the ICU

  7 day

• The number of patients who required rescue analgesic

  72 hour

Study Arms (2)

Pectointercostal Fascial Plane Block Group

ACTIVE COMPARATOR

In addition to routine standard perioperative and postoperative analgesia protocol patients will receive bilateral local anesthetic injections at the Pectointercostal Fascial Plane Block

Other: local anesthetic injection

Control

OTHER

Patients will receive standard perioperative and postoperative analgesia protocol

Other: Standard perioperative and postoperative analgesia protocol

Interventions

local anesthetic injection OTHER

Ultrasound-guided pectointercostal fascial plane block group using 20 mL of 0.25% bupivacaine

Pectointercostal Fascial Plane Block Group

Standard perioperative and postoperative analgesia protocol OTHER

postoperative IV morphine PCA and paracetamol will be given. If VAS is 3 or above, 75 mg dexketoprofen trometamol will be administered.

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA 3 risk score patients scheduled for elective open heart surgery

You may not qualify if:

• Emergent surgery
• Previous thoracotomy
• LVEF \<30
• Patients with psychiatric disorders
• Presence of hematological disease
• Patients with alcohol-drug addiction
• Patients who use daily opioids for any reason
• Chronic analgesic use
• Allergy to local anesthetics
• BMI \>40

Sponsors & Collaborators

• Konya Meram State Hospital: lead

Study Sites (1)

Betul Kozanhan

Konya, 42005, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Anesthetics, Local

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 18, 2024
• Study Start: January 18, 2024
• Primary Completion: May 28, 2025
• Study Completion: May 28, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05

Locations

TU (1)