Pectointercostal Fascial Plane Block Chronic Pain Sternotomy

Chronic Pain Clinical Trial

— PIFB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06210126
• Other study ID #: 12-31
• Status: Recruiting
• Phase: N/A
• Start date: January 18, 2024
• Est. completion date: December 28, 2024

Study information

• Verified date: January 2024
• Source: Konya Meram State Hospital
• Contact: Betül kozanhan, M.D.
• Phone: +905055044808
• Email: betulkozanhan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 28, 2024
• Est. primary completion date: December 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Other:
• local anesthetic injection
Ultrasound-guided pectointercostal fascial plane block group using 20 mL of 0.25% bupivacaine
• 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.

Locations

Country	Name	City	State
Turkey	Betul Kozanhan	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Konya Meram State Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to extubation	After the operation, the time until the patient is extubated will be recorded.	24 hour
Secondary	Postoperative pain score	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).	72 hour
Secondary	Postoperative nausea and vomiting (PONV)	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.	72 hour
Secondary	Length of stay in the ICU	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.	7 day
Secondary	The number of patients who required rescue analgesic	The number of patients who require rescue analgesic will be recorded at 0, 3, 6, 12, 24, 36, 48, and 72 hours after extubation.	72 hour