Postoperative PainNCT07023874
Dexmedetomidine Combined With Bupivacaine in Ultrasound-guided Pecto-Intercostal Fascial Block in Cardiac Surgery
A study testing Bupivacaine group and bupivacaine + dexmedetomidine group in people with Postoperative Pain and Cardiac Surgery, run by Alexandria University.
Trial summary
Recent advancements in pain management techniques suggest that ultrasound-guided peripheral nerve blocks may significantly benefit patients undergoing cardiac surgery. One noteworthy approach is the interfascial thoracic wall plane block, which has become an essential element of multimodal analgesia for post-cardiac… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Postoperative Pain, Cardiac Surgery
- What is being tested?
- Bupivacaine group and bupivacaine + dexmedetomidine group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 1 Nov 2025
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60 years.
- Both sexes.
- ASA physical status class II or III.
- Elective fast-tracking on-pump cardiac surgery.
Who cannot join
- The patient refused to participate in the study.
- Cognitive impairment or mental disorders.
- Hepatic and renal impairment.
- Congestive heart failure.
- Urgent/emergent surgery.
- BMI <18 and >35 (kg/m2).
Show all 12Show fewer
- Documented allergy to local anaesthetics or dexmedetomidine.
- Use of chronic pain medications.
- Previous sternotomy or chest surgery.
- Patients with a history of substance abuse.
- Requires the use of mechanical circulatory support pre-operatively.
- Patients who will not be candidates for fast-tracking extubation after block administration.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Dexmedetomidine Combined With Bupivacaine in Ultrasound-guided Pecto-Intercostal Fascial Block in Cardiac Surgery: A Randomized Controlled Trial
Recent advancements in pain management techniques suggest that ultrasound-guided peripheral nerve blocks may significantly benefit patients undergoing cardiac surgery. One noteworthy approach is the interfascial thoracic wall plane block, which has become an essential element of multimodal analgesia for post-cardiac surgery care. The pecto-intercostal fascial plane block (PIFPB) is a technique that utilizes ultrasound guidance to administer local anesthetic (LA) into the space between the intercostal muscles and the pectoralis major muscle. This intervention targets the anterior cutaneous branches of the thoracic nerves, particularly T2-T6, which are responsible for sensation in the anteromedial chest wall, including the sternum. Interestingly, the potential role of dexmedetomidine in improving the quality and prolonging the duration of analgesia for post-sternotomy pain through the pecto-intercostal fascial plane block remains unexamined in the current literature, indicating an area ripe for further research.
Read the detailed description
Optimal management of median sternotomy pain is a critical factor for achieving adequate recovery after cardiac surgery. The mechanisms of postoperative pain related to cardiac surgeries are intricate and multifaceted. The origins of cardiac surgery pain can be neurogenic, musculoskeletal, or visceral. The skin incision, subcutaneous tissue dissection, sternal retraction, preparation of the internal mammary artery graft, placement of chest drains, and sternal wires directly cause tissue injury. Inadequate pain control can potentially be associated with severe adverse effects such as respiratory compromise, increased myocardial work and oxygen demand, delayed mobilisation, and prolonged hospital stay. Further, increased postoperative pain scores are associated with an increased incidence of chronic pain syndromes.
Patient-controlled analgesia with intravenous opioids is most used to alleviate pain after cardiac surgery. Still, opioids can cause adverse effects, including delayed tracheal extubation, respiratory depression, sedation, ileus, nausea, vomiting, immunosuppression, cough suppression, drowsiness and increased risk of chronic pain. Epidural anaesthesia and paravertebral blocks can provide adequate analgesia with earlier extubation and reduced opioid use in cardiac surgical patients. Still, adverse effects related to pneumothorax, injury to the spinal cord, sympathectomy-induced hypotension, and devastating epidural hematoma after full heparinisation have limited their application in cardiac surgical patients.
An ultrasound-guided peripheral nerve block technique may benefit cardiac surgery patients. Interfascial thoracic wall plane blocks have emerged as a valuable component of multimodal analgesia after cardiac surgery. The pecto-intercostal fascial plane block (PIFPB) is an ultrasound-guided parasternal technique that involves the injection of local anaesthetic (LA) into the plane between the intercostal muscles and the pectoralis major muscle. This technique aims to block the anterior cutaneous branches of the thoracic nerves, specifically T2-T6, which innervate the anteromedial chest wall, including the sternum.
A single dose of a local anaesthetic in a peripheral nerve block could provide short-term analgesia, with bupivacaine typically lasting between 4 and 12 hours. Previous studies reported a mean duration of postoperative analgesia after PIFPB ranged from 8 to 12 hours.
Dexmedetomidine had been successfully used with local anaesthetic in peripheral nerve blocks to prolong the duration of analgesia. Dexmedetomidine is a highly selective alpha-2 adrenergic receptor agonist. As an adjuvant to LAs, dexmedetomidine has been the subject of increasing interest because it has the potential to prolong blockade duration. Dexmedetomidine facilitates nerve block through several mechanisms. It inhibits neurons' sodium channels and potassium currents while blocking the hyperpolarization-activated cyclic nucleotide-gated channel, enhancing activity-dependent hyperpolarisation.
The application of dexmedetomidine in enhancing the quality and duration of analgesia for post-sternotomy pain via the pecto-intercostal fascial plane block has yet to be explored in the existing literature. In this study, we hypothesise that dexmedetomidine in conjunction with bupivacaine within an ultrasound-guided PIFPB block may prolong the duration of postoperative analgesia, reduce opioid consumption and achieve better analgesia after sternotomy compared to bupivacaine alone.
- Conditions
- Postoperative Pain, Cardiac Surgery
- Being tested
- Bupivacaine group, bupivacaine + dexmedetomidine group
- Keywords
- pectointercostal fascial plain block, dexmedetomidine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine groupProcedure or surgery
Participants will receive bilateral ultrasound-guided pecto-intercostal fascial plane block
bupivacaine + dexmedetomidine groupProcedure or surgery
Participants will receive bilateral ultrasound-guided pecto intercostal fascial plane block using 30 mL of 0.25% bupivacaine with one µg/kg dexmedetomidine in each side
| Study group | Role | What they receive |
|---|---|---|
| bupivacaine only in pectointercostal fascial plain block | Active comparator | Participants will receive bilateral ultrasound-guided pecto-intercostal fascial plane block using 30 mL of 0.25% bupivacaine on each side Receives: Procedure: Bupivacaine group |
| bupivacaine and dexmedetomidine in pectointercostal fascial plain block | Experimental | Participants will receive bilateral ultrasound-guided pecto intercostal fascial plane block using 30 mL of 0.25% bupivacaine with one µg/kg dexmedetomidine on each side. Receives: Procedure: bupivacaine + dexmedetomidine group |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of opioid consumption at 24 hours after ICU admission
Postoperative total fentanyl consumption: total dose of fentanyl (µg/kg) administered postoperatively during the first postoperative 24 h after ICU admission.
Measured: 24 hours after ICU admission
Secondary outcomes (4)
time to extubation
Time to extubation (minutes): duration between ICU admission and tracheal extubation
Measured: 6 hours after ICU admiision
the intensity of postoperative pain at rest and upon coughing
The Numeric Rating Scale (NRS) (0-10) will be assessed at rest and cough, with 0 as "no pain," 1-3 as "mild pain," 4-6 as "moderate pain," and 7 10 as "severe pain." If the NRS for pain is more or equal to 4 at any point, then rescue analgesia will be administered. It will be measured immediately after extubation, 2, 4, 8, 12, and 24 hours after extubation.
Measured: 24 hours after extubation
time to first rescue analgesia
The time until the first request of fentanyl analgesia is recorded from the ICU admission time.
Measured: 24 hour after ICU admission
patient satisfaction
patient satisfaction with postoperative pain control will be assessed on a four-point scale: Excellent, Good, Fair, and Poor.
Measured: 24 hour after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Elbardan, Alexandria University
- Investigators
- LECTURER OF ANESTHESIA AND SURGICAL INTENSIVE CARE, Principal investigator, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07023874
- Sponsor's protocol ID
- 0108877
- Status last verified
- Jun 2025
- First submitted
- 8 Jun 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Combined With Bupivacaine in Ultrasound-guided Pecto-Intercostal Fascial Block in Cardiac Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07023874
- Acronym / sponsor ID
- 0108877
- Conditions
- Postoperative Pain, Cardiac Surgery
- Keywords
- pectointercostal fascial plain block, dexmedetomidine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 17 Jun 2025 (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.
Recent advancements in pain management techniques suggest that ultrasound-guided peripheral nerve blocks may significantly benefit patients undergoing cardiac surgery. One noteworthy approach is the interfascial thoracic wall plane block, which has become an essential element of multimodal analgesia for post-cardiac surgery care. The pecto-intercostal fascial plane block (PIFPB) is a technique that utilizes ultrasound guidance to administer local anesthetic (LA) into the space between the intercostal muscles and the pectoralis major muscle. This intervention targets the anterior cutaneous branches of the thoracic nerves, particularly T2-T6, which are responsible for sensation in the anteromedial chest wall, including the sternum. Interestingly, the potential role of dexmedetomidine in improving the quality and prolonging the duration of analgesia for post-sternotomy pain through the pecto-intercostal fascial plane block remains unexamined in the current literature, indicating an area ripe for further research.
Detailed description
Optimal management of median sternotomy pain is a critical factor for achieving adequate recovery after cardiac surgery. The mechanisms of postoperative pain related to cardiac surgeries are intricate and multifaceted. The origins of cardiac surgery pain can be neurogenic, musculoskeletal, or visceral. The skin incision, subcutaneous tissue dissection, sternal retraction, preparation of the internal mammary artery graft, placement of chest drains, and sternal wires directly cause tissue injury. Inadequate pain control can potentially be associated with severe adverse effects such as respiratory compromise, increased myocardial work and oxygen demand, delayed mobilisation, and prolonged hospital stay. Further, increased postoperative pain scores are associated with an increased incidence of chronic pain syndromes.
Patient-controlled analgesia with intravenous opioids is most used to alleviate pain after cardiac surgery. Still, opioids can cause adverse effects, including delayed tracheal extubation, respiratory depression, sedation, ileus, nausea, vomiting, immunosuppression, cough suppression, drowsiness and increased risk of chronic pain. Epidural anaesthesia and paravertebral blocks can provide adequate analgesia with earlier extubation and reduced opioid use in cardiac surgical patients. Still, adverse effects related to pneumothorax, injury to the spinal cord, sympathectomy-induced hypotension, and devastating epidural hematoma after full heparinisation have limited their application in cardiac surgical patients.
An ultrasound-guided peripheral nerve block technique may benefit cardiac surgery patients. Interfascial thoracic wall plane blocks have emerged as a valuable component of multimodal analgesia after cardiac surgery. The pecto-intercostal fascial plane block (PIFPB) is an ultrasound-guided parasternal technique that involves the injection of local anaesthetic (LA) into the plane between the intercostal muscles and the pectoralis major muscle. This technique aims to block the anterior cutaneous branches of the thoracic nerves, specifically T2-T6, which innervate the anteromedial chest wall, including the sternum.
A single dose of a local anaesthetic in a peripheral nerve block could provide short-term analgesia, with bupivacaine typically lasting between 4 and 12 hours. Previous studies reported a mean duration of postoperative analgesia after PIFPB ranged from 8 to 12 hours.
Dexmedetomidine had been successfully used with local anaesthetic in peripheral nerve blocks to prolong the duration of analgesia. Dexmedetomidine is a highly selective alpha-2 adrenergic receptor agonist. As an adjuvant to LAs, dexmedetomidine has been the subject of increasing interest because it has the potential to prolong blockade duration. Dexmedetomidine facilitates nerve block through several mechanisms. It inhibits neurons' sodium channels and potassium currents while blocking the hyperpolarization-activated cyclic nucleotide-gated channel, enhancing activity-dependent hyperpolarisation.
The application of dexmedetomidine in enhancing the quality and duration of analgesia for post-sternotomy pain via the pecto-intercostal fascial plane block has yet to be explored in the existing literature. In this study, we hypothesise that dexmedetomidine in conjunction with bupivacaine within an ultrasound-guided PIFPB block may prolong the duration of postoperative analgesia, reduce opioid consumption and achieve better analgesia after sternotomy compared to bupivacaine alone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bupivacaine only in pectointercostal fascial plain block | Active comparator | Procedure: Bupivacaine groupParticipants will receive bilateral ultrasound-guided pecto-intercostal fascial plane block using 30 mL of 0.25% bupivacaine on each side |
| bupivacaine and dexmedetomidine in pectointercostal fascial plain block | Experimental | Procedure: bupivacaine + dexmedetomidine groupParticipants will receive bilateral ultrasound-guided pecto intercostal fascial plane block using 30 mL of 0.25% bupivacaine with one µg/kg dexmedetomidine on each side. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-60 years.
- Both sexes.
- ASA physical status class II or III.
- Elective fast-tracking on-pump cardiac surgery.
Key exclusion criteria (12 listed)
- The patient refused to participate in the study.
- Cognitive impairment or mental disorders.
- Hepatic and renal impairment.
- Congestive heart failure.
- Urgent/emergent surgery.
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 |
|---|---|---|
| Bupivacaine groupParticipants will receive bilateral ultrasound-guided pecto-intercostal fascial plane block | Procedure or surgery | bupivacaine only in pectointercostal fascial plain block |
| bupivacaine + dexmedetomidine groupParticipants will receive bilateral ultrasound-guided pecto intercostal fascial plane block using 30 mL of 0.25% bupivacaine with one µg/kg dexmedetomidine in each side | Procedure or surgery | bupivacaine and dexmedetomidine in pectointercostal fascial plain block |
Primary outcome
amount of opioid consumption at 24 hours after ICU admission
Time frame: 24 hours after ICU admission
Postoperative total fentanyl consumption: total dose of fentanyl (µg/kg) administered postoperatively during the first postoperative 24 h after ICU admission.
4 secondary outcomes
time to extubation
Time frame: 6 hours after ICU admiision
the intensity of postoperative pain at rest and upon coughing
Time frame: 24 hours after extubation
time to first rescue analgesia
Time frame: 24 hour after ICU admission
patient satisfaction
Time frame: 24 hour after ICU admission
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 17 Jun 2025.
- Individual participant dataSharing planned: No
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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.
LECTURER OF ANESTHESIA AND SURGICAL INTENSIVE CARE principal investigator
University of Alexandria
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine group and bupivacaine + dexmedetomidine group in people with Postoperative Pain and Cardiac Surgery, run by Alexandria University.
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 4 inclusion and 12 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 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact ISLAM MOHAMMED ELBARDAN, MD (0020 1112278083, Islam.elbardan@Alexmed.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
amount of opioid consumption at 24 hours after ICU admission (time frame: 24 hours after ICU admission). 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 17 Jun 2025; AzTrials last refreshed its copy on 8 Nov 2026.