An interventional study of Pecto-Intercostal Fascial Plane Block and Standardized Multimodal Systemic Analgesia in Chronic Poststernotomy Pain, sponsored by Izmir Katip Celebi University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Izmir Katip Celebi University · Not applicable, Interventional, and Prevention
This single-center, prospective, parallel-group randomized controlled trial will evaluate whether adding ultrasound-guided bilateral single-shot pecto-intercostal fascial plane block (PIFB) to standard multimodal systemic analgesia reduces the incidence of clinically significant chronic poststernotomy pain in adults undergoing elective isolated coronary artery bypass grafting (CABG) through median sternotomy.
A total of 180 eligible participants will be randomized in a 1:1 ratio to either standard general anesthesia with standardized multimodal systemic analgesia alone or the same perioperative analgesic regimen with the addition of bilateral PIFB performed after induction of general anesthesia and before surgical incision. In the PIFB group, 15 mL of 0.25% bupivacaine will be administered on each side under ultrasound guidance. Perioperative anesthesia, systemic analgesia, rescue analgesia, intensive care management, and routine postoperative care will otherwise be standardized between groups.
The primary outcome will be the proportion of participants with clinically significant chronic poststernotomy pain on postoperative day 90. This outcome will be defined as pain that develops or worsens after surgery, is localized to the sternotomy line or related thoracic surgical areas, persists or recurs at 3 months, has an average intensity of at least 3 on a 0-10 Numeric Rating Scale during the preceding 7 days, and is not better explained by another clinical condition.
Secondary outcomes will include early postoperative pain intensity, acute pain burden, opioid consumption, rescue analgesic requirements, time to first rescue analgesia, postoperative nausea and vomiting, time to extubation, duration of mechanical ventilation, intensive care unit and hospital length of stay, and persistent postoperative pain at day 30. Participants will be followed through postoperative day 90.
This single-center, prospective, parallel-group, randomized controlled trial will evaluate whether ultrasound-guided bilateral single-shot pecto-intercostal fascial plane block (PIFB), when added to standard multimodal systemic analgesia, reduces the incidence of clinically significant chronic poststernotomy pain in adults undergoing elective isolated coronary artery bypass grafting (CABG) through full median sternotomy.
A total of 180 eligible participants will be randomized in a 1:1 ratio to one of two groups. The control group will receive standard general anesthesia and standardized multimodal systemic analgesia. The intervention group will receive the same standard anesthesia and systemic analgesia protocol with the addition of ultrasound-guided bilateral single-shot PIFB after induction of general anesthesia and endotracheal intubation and before surgical incision. Randomization will be performed using a computer-generated sequence with concealed variable block sizes. Allocation concealment will be maintained until eligibility has been confirmed and written informed consent has been obtained.
The study will use blinded outcome assessment. The anesthesiologist performing the block and the operating room team cannot be blinded because of the nature of the intervention. However, investigators performing postoperative pain assessments and postoperative day 30 and day 90 follow-up evaluations will remain unaware of group allocation. No sham block or placebo injection will be used; therefore, the study will not be described as double-blind or placebo-controlled.
In participants assigned to the PIFB group, the block will be performed under ultrasound guidance by experienced anesthesiologists using a standardized technique. After identification of the target fascial plane between the pectoralis major muscle and the intercostal muscle layer and confirmation of needle position, 15 mL of 0.25% bupivacaine will be administered on each side, for a total volume of 30 mL and a total bupivacaine dose of 75 mg. The total dose will not exceed 2 mg/kg. Ultrasound visualization of local anesthetic spread within the target fascial plane will be confirmed.
Apart from administration of PIFB in the intervention group, perioperative management will be standardized between groups. General anesthesia, intraoperative monitoring, systemic analgesia, rescue analgesia, postoperative intensive care management, and routine postoperative care will follow the same institutional protocols in both groups. Rescue analgesia will not be withheld or delayed for study purposes.
Postoperative pain intensity will be assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain will be assessed separately at rest, during coughing or deep breathing, and during mobilization when clinically feasible. Planned early postoperative assessments will be performed at 6, 12, 24, 48, and 72 hours after surgery and on postoperative day 5, or on the day of discharge if discharge occurs earlier. If a participant is intubated, sedated, delirious, or otherwise unable to communicate reliably at a scheduled assessment time, the pain assessment will not be performed and the reason will be documented.
The primary outcome will be the proportion of participants with clinically significant chronic poststernotomy pain on postoperative day 90. Clinically significant chronic poststernotomy pain will be defined as pain that develops after surgery or is aggravated by surgery; is localized to the sternotomy line, parasternal region, chest tube insertion sites, or thoracic wall area related to internal thoracic artery dissection; persists or recurs at 3 months after surgery; has an average intensity of at least 3 on the 0-10 NRS during the preceding 7 days; and is not better explained by sternal wound infection, mediastinitis, sternal instability or nonunion, recurrent myocardial ischemia, malignancy, or another clinical condition. The primary outcome will be assessed by a blinded outcome assessor using a structured interview.
Secondary outcomes will include postoperative pain intensity at rest and with coughing, deep breathing, and mobilization; acute postoperative pain burden; intraoperative and postoperative opioid consumption; rescue analgesic requirement and number of rescue analgesic administrations; time to first rescue analgesia; postoperative nausea and vomiting; oversedation; respiratory depression and other opioid-related adverse effects; time to extubation; duration of invasive mechanical ventilation; intensive care unit length of stay; hospital length of stay; and persistent postoperative pain on postoperative day 30.
All opioids administered intraoperatively and postoperatively will be recorded by drug, dose, route, and time of administration and converted to morphine milligram equivalents. Postoperative opioid consumption will be evaluated over prespecified periods including 0-24, 0-48, and 0-120 hours.
At postoperative day 30, participants will undergo structured assessment for persistent surgery-related thoracic wall pain, including pain location, average and worst pain intensity during the preceding 7 days, relationship to rest and activity, ongoing analgesic use, sleep disturbance, functional limitation, and return to usual activities or work.
At postoperative day 90, participants will undergo the primary chronic poststernotomy pain assessment. Additional assessments will include presence of any chronic poststernotomy pain, pain intensity and localization, continuous or intermittent pain pattern, ongoing analgesic use, effects on sleep and daily activities, and neuropathic pain features. In participants reporting pain, neuropathic characteristics will be assessed using the DN4 and S-LANSS instruments specified in the protocol.
Participants will be followed from the preoperative assessment through postoperative day 90. The primary analysis will follow the intention-to-treat principle, with participants analyzed according to their original randomized group regardless of treatment crossover, incomplete block performance, protocol deviations, or other post-randomization events. A per-protocol analysis will be performed as a supportive sensitivity analysis.
5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.
This study's planned enrollment of 180 is above the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.
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Exclusion Criteria:
Participants assigned to the control group will receive standard general anesthesia and the standardized multimodal systemic analgesia protocol used for elective coronary artery bypass grafting at the study center. No regional analgesia procedure, sham block, or placebo injection will be performed. Rescue analgesia will be provided according to the prespecified study protocol when clinically indicated.
Other: Standardized Multimodal Systemic Analgesia
Participants assigned to the intervention group will receive the same standard general anesthesia and standardized multimodal systemic analgesia protocol as the control group, with the addition of ultrasound-guided bilateral single-shot pecto-intercostal fascial plane block (PIFB) after induction of general anesthesia and endotracheal intubation and before surgical incision. A total of 15 mL of 0.25% bupivacaine will be administered on each side under ultrasound guidance.
Procedure: Pecto-Intercostal Fascial Plane Block · Other: Standardized Multimodal Systemic Analgesia
Ultrasound-guided bilateral single-shot pecto-intercostal fascial plane block (PIFB) will be performed after induction of general anesthesia and endotracheal intubation and before surgical incision. The target fascial plane between the pectoralis major muscle and the intercostal muscle layer will be identified under ultrasound guidance. After confirmation of needle position and negative aspiration, 15 mL of 0.25% bupivacaine will be administered on each side, for a total volume of 30 mL and a total dose of 75 mg. The total bupivacaine dose will not exceed 2 mg/kg. Ultrasound visualization of local anesthetic spread within the target fascial plane will be confirmed.
All participants will receive the same standardized multimodal systemic analgesia protocol. Postoperatively, paracetamol 1 g intravenously every 6 hours will be administered during the first 24 hours, followed by paracetamol 1 g orally every 8 hours after oral intake is established. Tramadol hydrochloride 100 mg intravenously every 12 hours will also be administered unless clinically contraindicated. Nonsteroidal anti-inflammatory drugs are not mandatory components of the protocol and may be used only when clinically appropriate. If the Numeric Rating Scale pain score is 4 or higher at rest or with coughing or movement, intravenous morphine 2 mg will be administered as rescue analgesia, with further analgesic treatment provided according to clinical need.
Incidence of Clinically Significant Chronic Poststernotomy Pain
The proportion of participants with clinically significant chronic poststernotomy pain on postoperative day 90 will be assessed. Clinically significant chronic poststernotomy pain will be defined as pain that develops after surgery or is aggravated by surgery; is localized to the sternotomy line, parasternal region, chest tube insertion sites, or thoracic wall area related to internal thoracic artery dissection; persists or recurs at 3 months after surgery; and has an average intensity of at least 3 on the 0-10 Numeric Rating Scale (NRS) during the preceding 7 days. Pain better explained by sternal wound infection, mediastinitis, sternal instability or nonunion, recurrent myocardial ischemia, malignancy, or another clinical condition will not be classified as chronic poststernotomy pain. The outcome will be assessed by an outcome assessor blinded to treatment allocation. Higher incidence indicates a less favorable outcome.
Time frame: Postoperative Day 90
Postoperative Pain Intensity at Rest
Pain intensity at rest will be assessed using the 0-10 Numeric Rating Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Time frame: 6, 12, 24, 48, and 72 hours after surgery and postoperative day 5, or at hospital discharge if discharge occurs before postoperative day 5
Postoperative Pain Intensity During Coughing or Deep Breathing
Pain intensity during coughing or deep breathing will be assessed using the 0-10 Numeric Rating Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Time frame: 6, 12, 24, 48, and 72 hours after surgery and postoperative day 5, or at hospital discharge if discharge occurs before postoperative day 5
Postoperative Pain Intensity During Mobilization
Pain intensity during mobilization will be assessed using the 0-10 Numeric Rating Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity. Mobilization pain will be assessed only when mobilization is clinically feasible.
Time frame: 6, 12, 24, 48, and 72 hours after surgery and postoperative day 5, or at hospital discharge if discharge occurs before postoperative day 5
Intraoperative Opioid Consumption
Total opioid consumption administered during surgery will be recorded and converted to morphine milligram equivalents (MME). Higher values indicate greater opioid consumption.
Time frame: Intraoperative period
Requirement for Rescue Analgesia
The proportion of participants requiring at least one rescue analgesic intervention will be recorded. The protocol-defined primary criterion for rescue analgesia is a score of 4 or higher on the 0-10 Numeric Rating Scale (NRS) at rest or during coughing or movement; rescue analgesia may also be administered according to clinical need irrespective of the NRS threshold.
Time frame: From the end of surgery through postoperative day 5 or hospital discharge, whichever occurs first
Number of Rescue Analgesic Administrations
The total number of rescue analgesic administrations received by each participant during the assessment period will be recorded. Higher values indicate greater rescue analgesic requirements.
Time frame: From the end of surgery through postoperative day 5 or hospital discharge, whichever occurs first
Time to First Rescue Analgesia
Time from the end of surgery to the first administration of rescue analgesia will be recorded in hours. Participants who do not require rescue analgesia during the observation period will be recorded as having no rescue analgesic event during that period.
Time frame: From the end of surgery through postoperative day 5 or hospital discharge, whichever occurs first
Incidence of Postoperative Nausea
The proportion of participants experiencing at least one episode of postoperative nausea during the assessment period will be recorded.
Time frame: From the end of surgery through 120 hours after surgery or hospital discharge, whichever occurs first
Incidence of Postoperative Oversedation
The proportion of participants experiencing at least one episode of clinically significant oversedation during the assessment period will be recorded. Oversedation will be defined as inability to be easily awakened, requirement for repeated stimulation, or sedation sufficiently severe to cause clinically significant impairment of communication.
Time frame: From the end of surgery through 5 days after surgery or hospital discharge, whichever occurs first
Incidence of Respiratory Depression
The proportion of participants experiencing at least one episode of respiratory depression during the assessment period will be recorded. Respiratory depression will be defined as a respiratory rate below 8 breaths per minute, clinically significant inadequate ventilation, or opioid-associated impairment of oxygenation.
Time frame: From the end of surgery through 5 days after surgery or hospital discharge, whichever occurs first
Time to Tracheal Extubation
Time from the end of surgery to first tracheal extubation will be recorded in hours. Participants who do not undergo tracheal extubation during the observation period will be recorded as not having achieved the extubation event. Extubation decisions will be made by the responsible clinical team according to routine institutional criteria and will not be accelerated or delayed for study purposes.
Time frame: Up to postoperative day 90
Duration of Invasive Mechanical Ventilation
Total duration of postoperative invasive mechanical ventilation will be recorded in hours, from the end of surgery until final liberation from invasive mechanical ventilation. Higher values indicate a longer duration of invasive mechanical ventilation.
Time frame: Up to postoperative day 90
Intensive Care Unit Length of Stay
Length of stay in the intensive care unit (ICU) will be recorded in days, from admission to the ICU after surgery until final discharge from the ICU. Higher values indicate a longer ICU stay.
Time frame: Up to postoperative day 90
Hospital Length of Stay
Total hospital length of stay will be recorded in days, from the date of admission for surgery until final discharge from the index hospitalization. Higher values indicate a longer hospital stay.
Time frame: Up to postoperative day 90
Incidence of Persistent Postoperative Pain
The proportion of participants reporting persistent surgery-related pain involving the sternotomy or associated thoracic surgical areas on postoperative day 30 will be recorded.
Time frame: Postoperative Day 30
Presence of Any Chronic Poststernotomy Pain
The proportion of participants reporting pain that persists or recurs at 3 months after surgery and is considered related to the sternotomy or associated thoracic surgical areas will be recorded, regardless of pain intensity.
Time frame: Postoperative Day 90
Average Chronic Poststernotomy Pain Intensity
Among participants reporting chronic poststernotomy pain, a single recalled rating of average pain intensity during the preceding 7 days will be obtained on postoperative day 90 using the 0-10 Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Time frame: Postoperative Day 90
Worst Chronic Poststernotomy Pain Intensity
Among participants reporting chronic poststernotomy pain, a single recalled rating of the worst pain intensity experienced during the preceding 7 days will be obtained on postoperative day 90 using the 0-10 Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Time frame: Postoperative Day 90
Neuropathic Pain Features Assessed With the Douleur Neuropathique en 4 Questions (DN4)
Among participants reporting pain at postoperative day 90, neuropathic pain features will be assessed using the Douleur Neuropathique en 4 Questions (DN4). The DN4 consists of 10 dichotomously scored items, with a total score ranging from 0 to 10. Higher scores indicate a greater likelihood that the pain has a neuropathic component. A score of 4 or higher will be considered indicative of neuropathic pain characteristics.
Time frame: Postoperative Day 90
Neuropathic Pain Features Assessed With the Self-Report Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS)
Among participants reporting pain at postoperative day 90, neuropathic pain features will be assessed using the Self-Report Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS). The S-LANSS consists of 7 weighted items, with a total score ranging from 0 to 24. Higher scores indicate a greater likelihood that the pain has a neuropathic component. A score of 12 or higher will be considered indicative of pain with neuropathic characteristics.
Time frame: Postoperative Day 90
Cumulative Postoperative Opioid Consumption Through 24 Hours
Total opioid consumption during the first 24 postoperative hours will be converted to morphine milligram equivalents (MME). Higher values indicate greater opioid consumption.
Time frame: From the end of surgery through 24 hours after surgery
Cumulative Postoperative Opioid Consumption Through 48 Hours
Cumulative opioid consumption during the first 48 postoperative hours will be converted to morphine milligram equivalents (MME). Higher values indicate greater opioid consumption.
Time frame: From the end of surgery through 48 hours after surgery
Cumulative Postoperative Opioid Consumption Through 120 Hours
Cumulative opioid consumption through 120 postoperative hours will be converted to morphine milligram equivalents (MME). Higher values indicate greater opioid consumption.
Time frame: From the end of surgery through 120 hours after surgery or hospital discharge, whichever occurs first
Incidence of Postoperative Vomiting
The proportion of participants experiencing at least one episode of postoperative vomiting during the assessment period will be recorded.
Time frame: From the end of surgery through 120 hours after surgery or hospital discharge, whichever occurs first
Average Persistent Postoperative Pain Intensity
Among participants reporting persistent postoperative pain, a single recalled rating of average pain intensity during the preceding 7 days will be obtained on postoperative day 30 using the 0-10 Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Time frame: Postoperative Day 30
Worst Persistent Postoperative Pain Intensity
Among participants reporting persistent postoperative pain, a single recalled rating of the worst pain intensity experienced during the preceding 7 days will be obtained on postoperative day 30 using the 0-10 Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Time frame: Postoperative Day 30
Ongoing Analgesic Use for Persistent Postoperative Pain
The proportion of participants with persistent postoperative pain who report ongoing use of analgesic medication for surgery-related pain at postoperative day 30 will be recorded.
Time frame: Postoperative Day 30
Ongoing Analgesic Use for Chronic Poststernotomy Pain
The proportion of participants with chronic poststernotomy pain who report ongoing use of analgesic medication for surgery-related pain at postoperative day 90 will be recorded.
Time frame: Postoperative Day 90
Pain-Related Sleep DisturbanceDescription:
The proportion of participants with chronic poststernotomy pain who report sleep disturbance attributable to surgery-related pain at postoperative day 90 will be recorded.
Time frame: Postoperative Day 90
Pain-Related Physical Activity Limitation
The proportion of participants with chronic poststernotomy pain who report limitation of physical activity attributable to surgery-related pain at postoperative day 90 will be recorded.
Time frame: Postoperative Day 90
Pain-Related Impairment of Activities of Daily Living
The proportion of participants with chronic poststernotomy pain who report impairment of activities of daily living attributable to surgery-related pain at postoperative day 90 will be recorded.
Time frame: Postoperative Day 90
Plan to share: No — De-identified individual participant data collected in this study will not be made available to researchers outside the primary study team. No external individual participant data sharing is planned because the study protocol and informed consent do not include a prospective data-sharing arrangement.
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Start is estimated for Jan 2027; primary completion for Jan 2028, 12 months later.
Of 1,888 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's planned 12 months is close to that.
Counting every sponsor, half of 1,901 studies reached it within 11 months; a quarter within 6 and three quarters within 23.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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