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Completed

NCT Number: NCT06210126

Pectointercostal Fascial Plane Block Chronic Pain Sternotomy

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Betul Kozanhan

Konya, 42005, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

local anesthetic injection

Other

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

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.

Primary outcomes

  1. chronic pain

    Time frame: 3 months

    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.

Secondary outcomes

  1. Time to extubation

    Time frame: 24 hour

    After the operation, the time until the patient is extubated will be recorded.

  2. Postoperative pain score

    Time frame: 72 hour

    Pain levels will be evaluated with the visual analog scale (VAS) at 0, 3, 6, 12, 24, 36, 48, and 72 hours after extubation. VAS use numbers to rate pain from 0 (no pain) to 10 (worst pain).

  3. Postoperative nausea and vomiting (PONV)

    Time frame: 72 hour

    The patients will be verbally evaluated according to a descriptive five-point PONV scale at 0, 3, 6, 12, 24, 48 and 72 hours after extubation.

  4. Length of stay in the ICU

    Time frame: 7 day

    The time from admission to the ICU to the time of discharge to the hospital ward; during the hospital stay, an average of 7 days.

  5. The number of patients who required rescue analgesic

    Time frame: 72 hour

    The number of patients who require rescue analgesic will be recorded at 0, 3, 6, 12, 24, 36, 48, and 72 hours after extubation.

Sponsors and collaborators

Lead sponsor

Konya Meram State Hospital

Other

Registry information

Official study title

Effect of Pectointercostal Fascial Plane (PIF) Block on Postoperative Chronic Pain in Patients Undergoing Open Heart Surgery: Randomized, Controlled Study

Acronym: PIFB

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 18, 2024
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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