Clinical trial NCT06210126: Pectointercostal Fascial Plane Block Chronic Pain Sternotomy
Official title: Effect of Pectointercostal Fascial Plane (PIF) Block on Postoperative Chronic Pain in Patients Undergoing Open Heart Surgery: Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Konya Meram State Hospital
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: chronic pain
timeFrame: 3 months
Secondary outcomes:
measure: Time to extubation
timeFrame: 24 hour
measure: Postoperative pain score
timeFrame: 72 hour
measure: Postoperative nausea and vomiting (PONV)
timeFrame: 72 hour
measure: Length of stay in the ICU
timeFrame: 7 day
measure: The number of patients who required rescue analgesic
timeFrame: 72 hour
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Betul Kozanhan
Study officials:
References: