Pectointercostal Fascial Plane Block Chronic Pain Sternotomy

NCT ID: NCT06210126

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-18
• Study Completion Date: 2025-05-28

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.

Detailed Description

Chronic postsurgical pain (CPSP), defined as persistent pain at the surgical site or referred areas lasting at least three months post-surgery, poses a considerable challenge, notably after median sternotomy in cardiac procedures. Incidence rates, ranging from 28% to 56% within two years post-operation, exhibit variability, partly due to diverse presentations and potential underreporting by patients. The psychological impact of cardiac surgery often leads patients to normalize enduring pain, delaying the identification of chronic post-sternotomy pain.

The multifaceted etiology of CPSP after sternotomy remains incompletely understood. Factors such as neural sensitization during the acute phase, neuropathy from nerve entrapment or injury during surgery, musculoskeletal trauma from incisions, sternal complications, and infections contribute to this complex pain landscape. Inadequate management of acute perioperative pain can trigger central sensitization, a process-altering spinal pain pathway, and predispose individuals to hyperalgesia and chronic pain. Thus, effective acute pain control not only alleviates immediate postoperative discomfort but also potentially averts the onset of chronic pain.

Traditionally, opioids like fentanyl and morphine have been primary choices for post-cardiac surgery pain relief. However, their use is associated with dose-related side effects such as nausea, respiratory issues, chronic opioid dependence, and increased chronic pain risk. Implementing a multimodal approach, including NSAIDs, proves challenging due to bleeding and renal complications post-cardiac surgery. In contrast, regional analgesia offers an opioid-sparing alternative. Parasternal regional blocks like the pectointercostal fascial plane block (PIFB) present a low-risk option and have demonstrated efficacy in alleviating acute post-sternotomy pain.

Addressing this, a prospective, double-blinded randomized controlled trial aimed to evaluate whether a PIF block could provide effective perioperative analgesia and potentially mitigate the incidence of CPSP in patients undergoing sternotomy for cardiac surgery.

Conditions

Chronic Pain

Study Design

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

Study Groups

Pectointercostal Fascial Plane Block Group

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

Group Type: ACTIVE_COMPARATOR

local anesthetic injection

Intervention Type: OTHER

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

Control

Patients will receive standard perioperative and postoperative analgesia protocol

Group Type: OTHER

Standard perioperative and postoperative analgesia protocol

Intervention Type: OTHER

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

Interventions

local anesthetic injection

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

Intervention Type: OTHER

Standard perioperative and postoperative analgesia protocol

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Konya Meram State Hospital

OTHER

Sponsor Role: lead

Responsible Party

Betul Kozanhan

Prof. Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Betul Kozanhan

Konya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

12-31

Identifier Type: -

Identifier Source: org_study_id