Chronic PainPIFBNCT06210126
Pectointercostal Fascial Plane Block Chronic Pain Sternotomy
A study testing local anesthetic injection and Standard perioperative and postoperative analgesia protocol in people with Chronic Pain, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- local anesthetic injection and Standard perioperative and postoperative analgesia protocol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Jan 2024to 28 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 3 risk score patients scheduled for elective open heart surgery
Who cannot join
- Emergent surgery
- Previous thoracotomy
- LVEF <30
- Patients with psychiatric disorders
- Presence of hematological disease
- Patients with alcohol-drug addiction
Show all 10Show fewer
- Patients who use daily opioids for any reason
- Chronic analgesic use
- Allergy to local anesthetics
- BMI >40
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Pectointercostal Fascial Plane (PIF) Block on Postoperative Chronic Pain in Patients Undergoing Open Heart Surgery: Randomized, Controlled Study
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.
Read the 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
- Being tested
- local anesthetic injection, Standard perioperative and postoperative analgesia protocol
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
local anesthetic injectionOther
Ultrasound-guided pectointercostal fascial plane block group using 20 mL of 0.25% bupivacaine
Standard perioperative and postoperative analgesia protocolOther
postoperative IV morphine PCA and paracetamol will be given. If VAS is 3 or above, 75 mg dexketoprofen trometamol will be administered.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: local anesthetic injection |
| Control | Other | Patients will receive standard perioperative and postoperative analgesia protocol Receives: Other: Standard perioperative and postoperative analgesia protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (5)
Time to extubation
After the operation, the time until the patient is extubated will be recorded.
Measured: 24 hour
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).
Measured: 72 hour
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.
Measured: 72 hour
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.
Measured: 7 day
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.
Measured: 72 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start18 Jan 2024
- Primary completion28 May 2025
- Study completion28 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya Meram State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betul Kozanhan, Konya Meram State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06210126
- Sponsor's protocol ID
- 12-31
- Acronym
- PIFB
- Status last verified
- May 2025
- First submitted
- 20 Dec 2023
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pectointercostal Fascial Plane (PIF) Block on Postoperative Chronic Pain in Patients Undergoing Open Heart Surgery: Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT06210126
- Acronym / sponsor ID
- PIFB / 12-31
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Konya Meram State HospitalUniversity, hospital or other
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 28 May 2025 (actual)
- Study completion
- 28 May 2025 (actual)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pectointercostal Fascial Plane Block Group | Active comparator | Other: local anesthetic injectionIn addition to routine standard perioperative and postoperative analgesia protocol patients will receive bilateral local anesthetic injections at the Pectointercostal Fascial Plane Block |
| Control | Other | Other: Standard perioperative and postoperative analgesia protocolPatients will receive standard perioperative and postoperative analgesia protocol |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA 3 risk score patients scheduled for elective open heart surgery
Key exclusion criteria (10 listed)
- Emergent surgery
- Previous thoracotomy
- LVEF <30
- Patients with psychiatric disorders
- Presence of hematological disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| local anesthetic injectionUltrasound-guided pectointercostal fascial plane block group using 20 mL of 0.25% bupivacaine | Other | Pectointercostal Fascial Plane Block Group |
| Standard perioperative and postoperative analgesia protocolpostoperative IV morphine PCA and paracetamol will be given. If VAS is 3 or above, 75 mg dexketoprofen trometamol will be administered. | Other | Control |
Primary outcome
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.
5 secondary outcomes
Time to extubation
Time frame: 24 hour
Postoperative pain score
Time frame: 72 hour
Postoperative nausea and vomiting (PONV)
Time frame: 72 hour
Length of stay in the ICU
Time frame: 7 day
The number of patients who required rescue analgesic
Time frame: 72 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing local anesthetic injection and Standard perioperative and postoperative analgesia protocol in people with Chronic Pain, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
chronic pain (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.