Post Operative PainPhase 4PECsNCT06453681
Dexmedetomidine as an Adjuvant to Bupivacaine in Bilateral PECs for Pain Control After Cardiac Surgeries
A Phase 4 study testing bilateral PECS and Dexmedetomidine in people with Post Operative Pain, run by Kasr El Aini Hospital at 2 sites in Egypt.
Trial summary
the study aims to test the quality of analgesia provided by dexmedetomidine as an adjuvant to bupivacaine bilateral PECs block in patients scheduled for cardiothoracic surgeries with median sternotomy incision. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- bilateral PECS and Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Aug 2024to 2 May 2025
- Phase
- Phase 4
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All adult patients between the age groups of 25 and 65 years undergoing either coronary artery bypass grafting (CABG) or valve surgeries through midline sternotomy under general anesthesia
Who cannot join
- Skin erosions, hematomas or infection at the injection site.
- coagulopathy, ACT more than 150 seconds
- History of hypersensitivity to bupivacaine or Dexametomedine.
- The Patients who are unable to use the pain score.
- patients who will need prolonged post-operative ventilation or inotropic support.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Kasralainy school of medicine
Cairo, 11954
Kasralaini Faculty of Medicine
Cairo
About this study
Official title: Dexmedetomidine as an Adjuvant to Bupivacaine in Bilateral Pectoral Nerve Blocks for Postoperative Pain Control After Cardiac Surgeries: A Randomized Controlled Trial
the study aims to test the quality of analgesia provided by dexmedetomidine as an adjuvant to bupivacaine bilateral PECs block in patients scheduled for cardiothoracic surgeries with median sternotomy incision.
Read the detailed description
Background: Good postoperative analgesia in cardiac surgical patients helps in early recovery and ambulation. An alternative to parenteral, paravertebral, and thoracic epidural analgesia can be pectoralis nerve (Pecs) block, which is a novel, less invasive regional analgesic technique.
The study aims to test the quality of analgesia provided by dexmedetomidine as an adjuvant to bupivacaine bilateral PECs block in patients scheduled for cardiothoracic surgeries with median sternotomy incision.
sixty adult patients between the age groups of 25 and 65 years undergoing coronary artery bypass grafting or valve surgeries through midline sternotomy under general anesthesia were enrolled in the study. Patients were randomly allocated into two groups with 30 ineach group. Group 1 patients will receive bilateral Pecs block, whereas Group 2 patients will receive bilateral Pecs block with dexameditomedine postoperatively. Patients will be extubated once they fulfilled extubation criteria. Ventilator duration will be recorded. Patients will be interrogated for pain by visual analog scale (VAS) scoring at rest and cough. Inspiratory flow rate will be assessed using incentive spirometry.
- Conditions
- Post Operative Pain
- Being tested
- bilateral PECS, Dexmedetomidine
- Keywords
- PECs, dexameditomedine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bilateral PECSOther
Also called PECTORAL NERVE BLOCK
ectoralis nerve (Pecs) block, which is novel, less invasive regional analgesic technique.
DexmedetomidineDrug
Also called precedex
Dexmedetomidine is a potent α2 agonist. In our practice, dexmedetomidine is administered as an additive to regional anesthesia to improve the duration and quality of analgesia
| Study group | Role | What they receive |
|---|---|---|
| bupivacain | Active comparator | patients receive bilateral Pecs block with bupivacin 0.25%, Receives: Other: bilateral PECS |
| dexameditomedine bupivacain | Active comparator | patients received bilateral Pecs block with bupivacin 0.25% plus dexmedetomidine 0.5 μg/Kg as adjuvant. Receives: Other: bilateral PECS; Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The duration of analgesia
from block start time (time of LA injection) to block end time at which VAS score 4 or more)
Measured: up to 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start1 Aug 2024
- Primary completion1 Apr 2025
- Study completion2 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Mohamed Elhaddad, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453681
- Sponsor's protocol ID
- MD-75-2024
- Acronym
- PECs
- Status last verified
- Feb 2026
- First submitted
- 27 May 2024
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine as an Adjuvant to Bupivacaine in Bilateral Pectoral Nerve Blocks for Postoperative Pain Control After Cardiac Surgeries: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06453681
- Acronym / sponsor ID
- PECs / MD-75-2024
- Conditions
- Post Operative Pain
- Keywords
- PECs, dexameditomedine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 2 May 2025 (actual)
- First posted
- 12 Jun 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.
the study aims to test the quality of analgesia provided by dexmedetomidine as an adjuvant to bupivacaine bilateral PECs block in patients scheduled for cardiothoracic surgeries with median sternotomy incision.
Detailed description
Background: Good postoperative analgesia in cardiac surgical patients helps in early recovery and ambulation. An alternative to parenteral, paravertebral, and thoracic epidural analgesia can be pectoralis nerve (Pecs) block, which is a novel, less invasive regional analgesic technique.
The study aims to test the quality of analgesia provided by dexmedetomidine as an adjuvant to bupivacaine bilateral PECs block in patients scheduled for cardiothoracic surgeries with median sternotomy incision.
sixty adult patients between the age groups of 25 and 65 years undergoing coronary artery bypass grafting or valve surgeries through midline sternotomy under general anesthesia were enrolled in the study. Patients were randomly allocated into two groups with 30 ineach group. Group 1 patients will receive bilateral Pecs block, whereas Group 2 patients will receive bilateral Pecs block with dexameditomedine postoperatively. Patients will be extubated once they fulfilled extubation criteria. Ventilator duration will be recorded. Patients will be interrogated for pain by visual analog scale (VAS) scoring at rest and cough. Inspiratory flow rate will be assessed using incentive spirometry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| bupivacain | Active comparator | Other: bilateral PECSpatients receive bilateral Pecs block with bupivacin 0.25%, |
| dexameditomedine bupivacain | Active comparator | Other: bilateral PECS, Drug: Dexmedetomidinepatients received bilateral Pecs block with bupivacin 0.25% plus dexmedetomidine 0.5 μg/Kg as adjuvant. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients between the age groups of 25 and 65 years undergoing either coronary artery bypass grafting (CABG) or valve surgeries through midline sternotomy under general anesthesia
Key exclusion criteria (5 listed)
- Skin erosions, hematomas or infection at the injection site.
- coagulopathy, ACT more than 150 seconds
- History of hypersensitivity to bupivacaine or Dexametomedine.
- The Patients who are unable to use the pain score.
- patients who will need prolonged post-operative ventilation or inotropic support.
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 |
|---|---|---|
| bilateral PECSAlso: PECTORAL NERVE BLOCKectoralis nerve (Pecs) block, which is novel, less invasive regional analgesic technique. | Other | bupivacain, dexameditomedine bupivacain |
| DexmedetomidineAlso: precedexDexmedetomidine is a potent α2 agonist. In our practice, dexmedetomidine is administered as an additive to regional anesthesia to improve the duration and quality of analgesia | Drug | dexameditomedine bupivacain |
Primary outcome
The duration of analgesia
Time frame: up to 24 hour
from block start time (time of LA injection) to block end time at which VAS score 4 or more)
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 19 Feb 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing bilateral PECS and Dexmedetomidine in people with Post Operative Pain, run by Kasr El Aini Hospital at 2 sites in Egypt.
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 5 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 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The duration of analgesia (time frame: up to 24 hour). 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 19 Feb 2026.