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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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". | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Total intraoperative opioid | Total intraoperative opioid usage in terms of morphine equivalent | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to extubation | Perioperative | |
| Time to first incentive spirometry use | Perioperative | |
| Time to ambulation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caroline Chahine, MD | Contact | + 961 1 200800 | 5168 | caroline.chahine@lau.edu.lb |
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Only de-identified research-related clinical data will be shared on reasonable request.
After the publication of the study manuscript.
Researchers will be able to access the IPD and supporting information mentioned above only with a reasonable request. After assessment and in the case of approval, a data sharing agreement must be made between the study PI, the study institutional review board, and the researcher/entity requesting the de-identified dataset.
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| Ropivacaine | Drug | Ropivacaine only in the Bilateral single-shot Ultrasound-guided Erector Spinae Plane Block: 20ml/side of 0.375% ropivacaine |
|
| 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." | Postoperatively until 48 hours post-extubation |
| Perioperative |
| Total length of ICU stay | Perioperative |
| Sedation score | Sedation score postextubation measured using the Ramsay Sedation Scale. The Ramsay Sedation Scale ranges from 1 to 6, where 1 signifies "Awake; agitate or restless or both" and 6 signifies "asleep; no response to glabellar tap or loud auditory stimulus". | Perioperative |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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