Addition of Dexmedetomidine to Ropivacaine in Bilateral Erector Spinae Plane Block in Patients Undergoing Coronary Artery Bypass Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dexmedetomidine, Ropivacaine.
- Who it may be relevant to
- Registry conditions: Pain, Pain Management Following Cardiopulmonary Bypass Surgery, Erector Spinae Plane Block. Basic parameters: 25 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Drug Dexmedetomidine
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) - Drug Ropivacaine
Ropivacaine only in the Bilateral single-shot Ultrasound-guided Erector Spinae Plane Block: 20ml/side of 0.375% ropivacaine
Primary outcome measures
- 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)]
Secondary outcome measures (3)
- 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]
Eligibility criteria
Inclusion criteria
- 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
- No infection at the site of injection
- No contraindication for ESP block (thrombocytopenia, anticoagulation therapy)
- No documented allergy to ropivacaine or dexmedetomidine
Exclusion criteria
- 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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06981949 · LAUMCRH.CC1.23/Apr/2025