PainPhase 4NCT06981949
Addition of Dexmedetomidine to Ropivacaine in Bilateral Erector Spinae Plane Block in Patients Undergoing Coronary Artery Bypass Surgery
A Phase 4 study testing Dexmedetomidine and Ropivacaine in people with Pain and Pain Management Following Cardiopulmonary Bypass Surgery, run by Lebanese American University.
Trial summary
Coronary artery bypass surgery (CABG), typically performed through a median sternotomy, causes significant postoperative pain. Managing this pain effectively while reducing reliance on opioids is essential, as opioids can lead to side effects such as respiratory depression, nausea, and potential for dependence. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Pain, Pain Management Following Cardiopulmonary Bypass Surgery, Erector Spinae Plane Block
- What is being tested?
- Dexmedetomidine and Ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2025to 16 May 2026
- Phase
- Phase 4
- 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 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range: 25 - 80 years old
- Planned for elective OFF PUMP CABG
- Cognitively not impaired
- American Society of Anesthesiologists class 3
- Left ventricular ejection fraction ≥40%
- Consent form for the study signed
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- No infection at the site of injection
- No contraindication for ESP block (thrombocytopenia, anticoagulation therapy)
- No documented allergy to ropivacaine or dexmedetomidine
Who cannot join
- Refusal to participate in the study
- Emergency surgery
- American Society of Anesthesiologists class >3
- Left ventricular ejection fraction <40%
- Infection at the site of injection for ultrasound-guided ESPB
- Coagulation disorders
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- Documented allergy to ropivacaine or dexmedetomidine
- Greater than first-degree heart block
- Bradycardia (heart rate [HR] < 50 bpm)
- Pregnancy
- BMI ≥40
- Psychiatric illnesses that would interfere with the assessment of pain scores
- History of alcohol or drug abuse and chronic analgesic use
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: The Addition of Dexmedetomidine to Ropivacaine in Bilateral Erector Spinae Plane Block in Patients Undergoing Coronary Artery Bypass Surgery - A Double-blinded Randomized Clinical Trial
Coronary artery bypass surgery (CABG), typically performed through a median sternotomy, causes significant postoperative pain. Managing this pain effectively while reducing reliance on opioids is essential, as opioids can lead to side effects such as respiratory depression, nausea, and potential for dependence. Regional anesthesia techniques like the erector spinae plane block (ESPB) have emerged as promising tools to control pain and support recovery.
This randomized, double-blind clinical trial evaluates whether adding dexmedetomidine, a sedative and analgesic, to ropivacaine, a local anesthetic, in bilateral ESPB can improve pain control after off-pump CABG surgery. The study is conducted at the Lebanese American University Medical Center - Rizk Hospital.
Read more
A total of 110 adult patients undergoing elective surgery are randomly assigned to one of two groups:
- Group R: Receives ropivacaine alone in the ESPB.
- Group RD: Receives ropivacaine with dexmedetomidine.
The nerve block is administered before anesthesia. The primary outcome is the duration of effective pain relief (pain score ≤4) before the patient needs opioid medication, assessed up to 24 hours after extubation.
Secondary outcomes include:
- Pain scores monitored for up to 48 hours post-extubation
- Total intraoperative opioid use
- Time to extubation, ambulation, and incentive spirometry use
- ICU stay duration
- Side effects such as nausea, bradycardia, or local anesthetic toxicity
This study supports efforts to reduce opioid use after heart surgery while maintaining effective pain management, aligning with enhanced recovery protocols and addressing the broader public health challenge of opioid overuse.
- Conditions
- Pain, Pain Management Following Cardiopulmonary Bypass Surgery, Erector Spinae Plane Block
- Being tested
- Dexmedetomidine, Ropivacaine
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Dexmedetomidine added to ropivacaine in the bilateral single-shot Ultrasound-guided erector spinae plane block that will be applied to each side (bilateral):
20ml/side of 0.375% ropivacaine+0.5 μg/kg/side of dexmedetomidine (lean body weight if BMI >30)
RopivacaineDrug
Ropivacaine only in the Bilateral single-shot Ultrasound-guided Erector Spinae Plane Block:
20ml/side of 0.375% ropivacaine
| Study group | Role | What they receive |
|---|---|---|
| Group Ropivacaine Only (R) | Active comparator | In Group R, patients will receive 20 ml of 0.375% ropivacaine in each side of a bilateral single-shot ultrasound-guided erector spinae plane block. Receives: Drug: Ropivacaine |
| Group Combination Ropivacaine and Dexmedetomidine (RD) | Experimental | In Group RD, patients will receive 20 ml of 0.375% ropivacaine plus 0.5 micrograms/kg of dexmedetomidine in each side of a bilateral single-shot ultrasound-guided erector spinae plane block. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesia time
The period during which the pain numerical rating scale score remains less than or equal to 4 and until the time the patient required the administration of opioid as the first administration. The numerical rating scale score is a 0-10 scale, where 0 represents "no pain" and 10 represents "worst pain imaginable".
Measured: From the moment the patient is awake in the Intensive Care Unit until the end of the patient's study inclusion time (48 hours after extubation)
Secondary outcomes (3)
Total intraoperative opioid
Total intraoperative opioid usage in terms of morphine equivalent
Measured: Intraoperatively
Total amount of rescue analgesics used
Rescue analgesia requirements, including morphine or other than morphine, includes the total amount of each rescue analgesic used
Measured: Postoperatively until 48 hours post-extubation
Pain score
Pain scores postoperatively related to chest pain: measured using the numerical rating scale to get pain scores on pre-specified time points. The minimum score is 0, "no pain at all," and the maximum score is 10, "worst possible pain."
Measured: Postoperatively until 48 hours post-extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start15 May 2025 (estimated)
- Primary completion15 May 2026 (estimated)
- Study completion16 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lebanese American University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caroline Chahine, Lebanese American University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06981949
- Sponsor's protocol ID
- LAUMCRH.CC1.23/Apr/2025
- Status last verified
- May 2025
- First submitted
- 3 May 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only de-identified research-related clinical data will be shared on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Addition of Dexmedetomidine to Ropivacaine in Bilateral Erector Spinae Plane Block in Patients Undergoing Coronary Artery Bypass Surgery - A Double-blinded Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06981949
- Acronym / sponsor ID
- LAUMCRH.CC1.23/Apr/2025
- Conditions
- Pain, Pain Management Following Cardiopulmonary Bypass Surgery, Erector Spinae Plane Block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Lebanese American UniversityUniversity, hospital or other
- Study start
- 15 May 2025 (estimated)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 16 May 2026 (estimated)
- First posted
- 21 May 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.
Coronary artery bypass surgery (CABG), typically performed through a median sternotomy, causes significant postoperative pain. Managing this pain effectively while reducing reliance on opioids is essential, as opioids can lead to side effects such as respiratory depression, nausea, and potential for dependence. Regional anesthesia techniques like the erector spinae plane block (ESPB) have emerged as promising tools to control pain and support recovery.
This randomized, double-blind clinical trial evaluates whether adding dexmedetomidine, a sedative and analgesic, to ropivacaine, a local anesthetic, in bilateral ESPB can improve pain control after off-pump CABG surgery. The study is conducted at the Lebanese American University Medical Center - Rizk Hospital.
A total of 110 adult patients undergoing elective surgery are randomly assigned to one of two groups:
- Group R: Receives ropivacaine alone in the ESPB.
- Group RD: Receives ropivacaine with dexmedetomidine.
The nerve block is administered before anesthesia. The primary outcome is the duration of effective pain relief (pain score ≤4) before the patient needs opioid medication, assessed up to 24 hours after extubation.
Secondary outcomes include:
- Pain scores monitored for up to 48 hours post-extubation
- Total intraoperative opioid use
- Time to extubation, ambulation, and incentive spirometry use
- ICU stay duration
- Side effects such as nausea, bradycardia, or local anesthetic toxicity
This study supports efforts to reduce opioid use after heart surgery while maintaining effective pain management, aligning with enhanced recovery protocols and addressing the broader public health challenge of opioid overuse.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Ropivacaine Only (R) | Active comparator | Drug: RopivacaineIn Group R, patients will receive 20 ml of 0.375% ropivacaine in each side of a bilateral single-shot ultrasound-guided erector spinae plane block. |
| Group Combination Ropivacaine and Dexmedetomidine (RD) | Experimental | Drug: DexmedetomidineIn Group RD, patients will receive 20 ml of 0.375% ropivacaine plus 0.5 micrograms/kg of dexmedetomidine in each side of a bilateral single-shot ultrasound-guided erector spinae plane block. |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age range: 25 - 80 years old
- Planned for elective OFF PUMP CABG
- Cognitively not impaired
- American Society of Anesthesiologists class 3
- Left ventricular ejection fraction ≥40%
Key exclusion criteria (13 listed)
- Refusal to participate in the study
- Emergency surgery
- American Society of Anesthesiologists class >3
- Left ventricular ejection fraction <40%
- Infection at the site of injection for ultrasound-guided ESPB
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 |
|---|---|---|
| DexmedetomidineDexmedetomidine added to ropivacaine in the bilateral single-shot Ultrasound-guided erector spinae plane block that will be applied to each side (bilateral): 20ml/side of 0.375% ropivacaine+0.5 μg/kg/side of dexmedetomidine (lean body weight if BMI >30) | Drug | Group Combination Ropivacaine and Dexmedetomidine (RD) |
| RopivacaineRopivacaine only in the Bilateral single-shot Ultrasound-guided Erector Spinae Plane Block: 20ml/side of 0.375% ropivacaine | Drug | Group Ropivacaine Only (R) |
Primary outcome
Analgesia time
Time frame: From the moment the patient is awake in the Intensive Care Unit until the end of the patient's study inclusion time (48 hours after extubation)
The period during which the pain numerical rating scale score remains less than or equal to 4 and until the time the patient required the administration of opioid as the first administration. The numerical rating scale score is a 0-10 scale, where 0 represents "no pain" and 10 represents "worst pain imaginable".
3 secondary outcomes
Total intraoperative opioid
Time frame: Intraoperatively
Total amount of rescue analgesics used
Time frame: Postoperatively until 48 hours post-extubation
Pain score
Time frame: Postoperatively until 48 hours post-extubation
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 21 May 2025.
- Individual participant dataSharing planned: Yes. Only de-identified research-related clinical data will be shared on reasonable request.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine and Ropivacaine in people with Pain and Pain Management Following Cardiopulmonary Bypass Surgery, run by Lebanese American 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 9 inclusion and 13 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 21 May 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.
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?
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 Caroline Chahine, MD (+ 961 1 200800 ext. 5168, caroline.chahine@lau.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analgesia time (time frame: From the moment the patient is awake in the Intensive Care Unit until the end of the patient's study inclusion time (48 hours after extubation)). 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 21 May 2025.