NCT Number: NCT06981949
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:
1. Group R: Receives ropivacaine alone in the ESPB. 2. 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:
1. Pain scores monitored for up to 48 hours post-extubation 2. Total intraoperative opioid use 3. Time to extubation, ambulation, and incentive spirometry use 4. ICU stay duration 5. 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.
Trial opening soon.
Get Notified25 year–80 year
All sexes
Interventional
Phase 4
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
Ropivacaine only in the Bilateral single-shot Ultrasound-guided Erector Spinae Plane Block:
20ml/side of 0.375% ropivacaine
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".
Time frame: Intraoperatively
Total intraoperative opioid usage in terms of morphine equivalent
Time frame: Postoperatively until 48 hours post-extubation
Rescue analgesia requirements, including morphine or other than morphine, includes the total amount of each rescue analgesic used
Time frame: Postoperatively until 48 hours post-extubation
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."
Time frame: Perioperative
Time frame: Perioperative
Time frame: Perioperative
Time frame: Perioperative
Time frame: Perioperative
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".
Contact information is provided by the study sponsor or research team.
Lebanese American University
Other
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
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