Bypass SurgeryPIP-PAINNCT07759570
Parasternal Intercostal Plane Catheter for Pain Control After CABG Surgery
A study testing Parasternal blocks in people with Bypass Surgery and Arrythmia, run by Koc University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Coronary artery bypass graft (CABG) surgery performed via sternotomy (incision of the breastbone) can cause severe pain after surgery; this can slow recovery and increase the need for opioid pain relievers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bypass Surgery, Arrythmia, Postoperative Pain
- What is being tested?
- Parasternal blocks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Aug 2026to 15 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with coronary artery disease scheduled for coronary artery bypass graft surgery
Who cannot join
- Under 18 years of age
- ASA (American Society of Anesthesiologists) Class V patients
- Non-elective emergency cases
- Patient refusal to participate in the study
- Language barrier
- Patients who have previously undergone sternotomy
Show all 15Show fewer
- History of significant psychiatric disorders
- Patients with known long-term opioid use
- Patients with potential contraindications to nerve blocks (bleeding diathesis, infection, and allergy to local anesthetics)
- Patients with an ejection fraction <40%
- Patients with right ventricular systolic dysfunction (patients with TAPSE <1.8 cm)
- Patients with a left atrial diameter >4 cm
- Patients with severe valvular heart disease
- Patients undergoing concomitant valvular heart surgery
- Patients with a history of atrial flutter and/or atrial fibrillation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Koc University Hospital
Istanbul, Zeytinburnu, 34010
Rafet Onur Görgülü, MD, +90 538 731 71 39, ronurgorgulu@gmail.com
Muhammet Selman Söğüt, MD, +90 505 618 32 19, ssogut@kuh.ku.edu.tr
About this study
Official title: The Effect of Superficial Parasternal Intercostal Plane Catheter Analgesia Following Sternotomy in Coronary Artery Bypass Surgery on Postoperative Pain: A Prospective Randomized Controlled Trial
Coronary artery bypass graft (CABG) surgery performed via sternotomy (incision of the breastbone) can cause severe pain after surgery; this can slow recovery and increase the need for opioid pain relievers. This study investigates whether placing a catheter to deliver a local anesthetic to the superficial parasternal intercostal plane reduces pain following this type of heart surgery. Patients undergoing CABG via sternotomy will be randomly assigned to either the catheter-based analgesia group or the standard pain management group. The researchers will compare postoperative pain levels and analgesic medication requirements between the two groups to determine whether this technique improves postoperative pain control.
Read the detailed description
Patients undergoing coronary artery bypass surgery will be included. Patients will be divided into two groups: the block group, in which a bilateral superficial parasternal plexus catheter will be inserted, and the control group, in which no parasternal plexus block or catheter will be administered.
In the block group, the catheter placement will be performed after completion of the surgery and before the patient is transferred to the ICU, under ultrasound guidance (Venue Go, GE, L4-T12 high-frequency linear probe). The probe will be positioned transversely across the costal cartilage, parallel to the sternum, in a parasagittal orientation at the level of 3rd rib. A 5-cm Tuohy needle will be inserted 2 cm lateral to the midline and advanced between the pectoralis major and external intercostal muscles at the third parasternal intercostal space. Needle tip position will be confirmed by negative aspiration for blood or air, followed by injection of 20 mL of bupivacaine 0.2% into the parasternal plane. Correct needle position will be confirmed by visualization of local anesthetic spread and hydrodissection separating the pectoralis major from the ribs and external intercostal muscles. A catheter (Tuohy Ultra-360 18G, B. Braun Contiplex, 400 mm) will then be placed into the parasternal intercostal space. Catheter position will be confirmed by ultrasound visualization of spread of 10 mL saline, after which the catheter will be secured. The procedure will be performed bilaterally. Postoperatively, 20 mL of bupivacaine 0.2% will be administered by the clinician through each parasternal catheter at 12, 24, 36, 48, 60, and 72 hours. Catheters will be removed by the clinician at 72 hours. Catheter-related complications, including bleeding, infection, and dislocation, will be recorded.
In the control group, no parasternal plexus block or catheter will be placed.
Intraoperative anesthesia technique will be identical in both groups. All patients will be admitted to the ICU orotracheally intubated and will be extubated in the ICU rather than in the operating room.
Pain nurses will assess all patients every 12 hours for 72 hours postoperatively. At each visit, pain score will be recorded using the Visual Analog Scale, where 0 corresponds to no pain and 10 corresponds to worst pain, assessed both at rest and during movement. Postoperative opioid consumption will be monitored via a patient-controlled analgesia device. The Morphine PCA solution will be prepared at a concentration of 1 mg/mL, with no background infusion, a bolus dose of 1 mL, and a lockout interval of 15 minutes. Additional (rescue) opioid analgesic requirements will be recorded by pain monitoring nurses. Rescue analgesia in both groups will consist of tramadol 1 mg/kg administered intravenously.
Patients' heart rhythm will be monitored continuously via telemetry throughout their hospital stay. Atrial tachyarrhythmias, including atrial flutter and atrial fibrillation, will be recorded throughout the hospital stay. Nausea, vomiting, and constipation will be recorded for 72 hours postoperatively.
Patient satisfaction will be assessed using a 5-point Likert scale, where 1 corresponds to strongly not satisfied and 5 corresponds to strongly satisfied. Hospital length of stay, ICU length of stay, and time to extubation in the ICU will be recorded for both groups.
- Conditions
- Bypass Surgery, Arrythmia, Postoperative Pain
- Being tested
- Parasternal blocks
- Keywords
- parasternal block, postoperative analgesia, cardiovascular surgery, arrhythmia, regional anesthesia
- Medical subject headings
- Arrhythmias, Cardiac, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parasternal blocksOther
Bilateral superficial parasternal block catheters will be placed at the end of the surgery, at the level of 3rd rib using ultrasound guidance
| Study group | Role | What they receive |
|---|---|---|
| Block group | Active comparator | Patiens receiving bilateral superficial parasternal catheter at the end of the surgery Receives: Other: Parasternal blocks |
| Control group | No intervention | No superficial parasternal catheter will be placed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative opioid consumption at 24 hours post-operatively (mg morphine equivalent).
Cumulative opioid consumption (patient controlled analgesia and rescue analgesia) at the first 24 hours postoperatively
Measured: Postoperative 24 hours
Secondary outcomes (14)
Resting NRS pain scores at 12, 24, 36, 48, 60, and 72 hours post-Surgery
Resting pain levels of patients will be evaluated using the numeric rating scale where 0 point meaning no pain and 10 points meaning the worst pain possible
Measured: at 12, 24, 36, 48, 60, and 72 hours post-Surgery
NRS pain scores associated with coughing at 12, 24, 36, 48, 60, and 72 hours post-Surgery
Pain levels associated with cough of patients will be evaluated using the numeric rating scale where 0 point meaning no pain and 10 points meaning the worst pain possible
Measured: at 12, 24, 36, 48, 60, and 72 hours post-Surgery
Total amount of opioids consumed during the first 72 hours after surgery
Measured: at the first 72 hours after surgery
Time to first rescue analgesic administration
The time when rescue analgesia is first administered during the postoperative recovery period
Measured: The patient will be monitored for the first 72 hours after surgery.
Time to extubation (in minutes) following admission to the postoperative intensive care unit
It will be recorded as postoperative minutes.
Measured: From intensive care unit admission until extubation, assessed up to 72 hours after intensive care unit admission
Length of stay in the intensive care unit
Measured: From intensive care unit admission until ICU discharge, assessed up to 14 days after intensive care unit admission
Length of hospital stay
Measured: From surgery until hospital discharge, assessed up to 30 days after intensive care unit admission
Assessment of Patient Satisfaction Using a numeric rating scale
Patients will be asked "How satisfied are you with your pain treatment" at 72 hours after surgery. A numeric rating scale will be used where 0 point meaning not satisfied at all and 10 points meaning can not be satisfied more.
Measured: at the 72nd hour postoperatively
Bleeding associated with a peripheral block catheter
Measured: for 72 hours after surgery
Postoperative Nausea and Vomiting
Measured: for 72 hours after surgery
Time to first bowel movement
Postoperative time to first bowel movement (defecation or flattus)
Measured: for 72 hours after surgery
Postoperative arrhythmia
Patients will be monitored via telemetry during their discharge period.
Measured: During the first 72 hours after surgery
Postoperative catheter-site infection
Measured: From the end of the surgery until hospital discharge, assessed up to 30 days after surgery
Dislocation of the parasternal block catheter
After the catheter is placed using ultrasound, the catheter site will be verified with saline.
Measured: During the first 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start30 Aug 2026 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bypass SurgeryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Koc University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafet Onur Gorgulu, Koc University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759570
- Sponsor's protocol ID
- 2026.216.IRB1.015
- Acronym
- PIP-PAIN
- Status last verified
- Aug 2026
- First submitted
- 31 Jul 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized patient data will be published in a public repository
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Superficial Parasternal Intercostal Plane Catheter Analgesia Following Sternotomy in Coronary Artery Bypass Surgery on Postoperative Pain: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07759570
- Acronym / sponsor ID
- PIP-PAIN / 2026.216.IRB1.015
- Conditions
- Bypass Surgery, Arrythmia, Postoperative Pain
- Keywords
- parasternal block, postoperative analgesia, cardiovascular surgery, arrhythmia, regional anesthesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Koc University HospitalUniversity, hospital or other
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 12 Aug 2026 (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.
Coronary artery bypass graft (CABG) surgery performed via sternotomy (incision of the breastbone) can cause severe pain after surgery; this can slow recovery and increase the need for opioid pain relievers. This study investigates whether placing a catheter to deliver a local anesthetic to the superficial parasternal intercostal plane reduces pain following this type of heart surgery. Patients undergoing CABG via sternotomy will be randomly assigned to either the catheter-based analgesia group or the standard pain management group. The researchers will compare postoperative pain levels and analgesic medication requirements between the two groups to determine whether this technique improves postoperative pain control.
Detailed description
Patients undergoing coronary artery bypass surgery will be included. Patients will be divided into two groups: the block group, in which a bilateral superficial parasternal plexus catheter will be inserted, and the control group, in which no parasternal plexus block or catheter will be administered.
In the block group, the catheter placement will be performed after completion of the surgery and before the patient is transferred to the ICU, under ultrasound guidance (Venue Go, GE, L4-T12 high-frequency linear probe). The probe will be positioned transversely across the costal cartilage, parallel to the sternum, in a parasagittal orientation at the level of 3rd rib. A 5-cm Tuohy needle will be inserted 2 cm lateral to the midline and advanced between the pectoralis major and external intercostal muscles at the third parasternal intercostal space. Needle tip position will be confirmed by negative aspiration for blood or air, followed by injection of 20 mL of bupivacaine 0.2% into the parasternal plane. Correct needle position will be confirmed by visualization of local anesthetic spread and hydrodissection separating the pectoralis major from the ribs and external intercostal muscles. A catheter (Tuohy Ultra-360 18G, B. Braun Contiplex, 400 mm) will then be placed into the parasternal intercostal space. Catheter position will be confirmed by ultrasound visualization of spread of 10 mL saline, after which the catheter will be secured. The procedure will be performed bilaterally. Postoperatively, 20 mL of bupivacaine 0.2% will be administered by the clinician through each parasternal catheter at 12, 24, 36, 48, 60, and 72 hours. Catheters will be removed by the clinician at 72 hours. Catheter-related complications, including bleeding, infection, and dislocation, will be recorded.
In the control group, no parasternal plexus block or catheter will be placed.
Intraoperative anesthesia technique will be identical in both groups. All patients will be admitted to the ICU orotracheally intubated and will be extubated in the ICU rather than in the operating room.
Pain nurses will assess all patients every 12 hours for 72 hours postoperatively. At each visit, pain score will be recorded using the Visual Analog Scale, where 0 corresponds to no pain and 10 corresponds to worst pain, assessed both at rest and during movement. Postoperative opioid consumption will be monitored via a patient-controlled analgesia device. The Morphine PCA solution will be prepared at a concentration of 1 mg/mL, with no background infusion, a bolus dose of 1 mL, and a lockout interval of 15 minutes. Additional (rescue) opioid analgesic requirements will be recorded by pain monitoring nurses. Rescue analgesia in both groups will consist of tramadol 1 mg/kg administered intravenously.
Patients' heart rhythm will be monitored continuously via telemetry throughout their hospital stay. Atrial tachyarrhythmias, including atrial flutter and atrial fibrillation, will be recorded throughout the hospital stay. Nausea, vomiting, and constipation will be recorded for 72 hours postoperatively.
Patient satisfaction will be assessed using a 5-point Likert scale, where 1 corresponds to strongly not satisfied and 5 corresponds to strongly satisfied. Hospital length of stay, ICU length of stay, and time to extubation in the ICU will be recorded for both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Block group | Active comparator | Other: Parasternal blocksPatiens receiving bilateral superficial parasternal catheter at the end of the surgery |
| Control group | No intervention | –No superficial parasternal catheter will be placed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with coronary artery disease scheduled for coronary artery bypass graft surgery
Key exclusion criteria (15 listed)
- Under 18 years of age
- ASA (American Society of Anesthesiologists) Class V patients
- Non-elective emergency cases
- Patient refusal to participate in the study
- Language barrier
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 |
|---|---|---|
| Parasternal blocksBilateral superficial parasternal block catheters will be placed at the end of the surgery, at the level of 3rd rib using ultrasound guidance | Other | Block group |
Primary outcome
Cumulative opioid consumption at 24 hours post-operatively (mg morphine equivalent).
Time frame: Postoperative 24 hours
Cumulative opioid consumption (patient controlled analgesia and rescue analgesia) at the first 24 hours postoperatively
14 secondary outcomes
Resting NRS pain scores at 12, 24, 36, 48, 60, and 72 hours post-Surgery
Time frame: at 12, 24, 36, 48, 60, and 72 hours post-Surgery
NRS pain scores associated with coughing at 12, 24, 36, 48, 60, and 72 hours post-Surgery
Time frame: at 12, 24, 36, 48, 60, and 72 hours post-Surgery
Total amount of opioids consumed during the first 72 hours after surgery
Time frame: at the first 72 hours after surgery
Time to first rescue analgesic administration
Time frame: The patient will be monitored for the first 72 hours after surgery.
Time to extubation (in minutes) following admission to the postoperative intensive care unit
Time frame: From intensive care unit admission until extubation, assessed up to 72 hours after intensive care unit admission
Length of stay in the intensive care unit
Time frame: From intensive care unit admission until ICU discharge, assessed up to 14 days after intensive care unit admission
Length of hospital stay
Time frame: From surgery until hospital discharge, assessed up to 30 days after intensive care unit admission
Assessment of Patient Satisfaction Using a numeric rating scale
Time frame: at the 72nd hour postoperatively
Bleeding associated with a peripheral block catheter
Time frame: for 72 hours after surgery
Postoperative Nausea and Vomiting
Time frame: for 72 hours after surgery
Time to first bowel movement
Time frame: for 72 hours after surgery
Postoperative arrhythmia
Time frame: During the first 72 hours after surgery
Postoperative catheter-site infection
Time frame: From the end of the surgery until hospital discharge, assessed up to 30 days after surgery
Dislocation of the parasternal block catheter
Time frame: During the first 72 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: Yes. Anonymized patient data will be published in a public repository
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parasternal blocks in people with Bypass Surgery and Arrythmia, run by Koc University 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 15 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: opening soon, as of the sponsor's last update on 12 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative opioid consumption at 24 hours post-operatively (mg morphine equivalent). (time frame: Postoperative 24 hours). 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 12 Aug 2026.