Clinical trial NCT06981949: Addition of Dexmedetomidine to Ropivacaine in Bilateral Erector Spinae Plane Block in Patients Undergoing Coronary Artery Bypass Surgery
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Pain
Pain Management Following Cardiopulmonary Bypass Surgery
Erector Spinae Plane Block
Lead sponsor: Lebanese American University
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 110
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

1. Age range: 25 - 80 years old
2. Planned for elective OFF PUMP CABG
3. Cognitively not impaired
4. American Society of Anesthesiologists class 3
5. Left ventricular ejection fraction ≥40%
6. Consent form for the study signed
7. No infection at the site of injection
8. No contraindication for ESP block (thrombocytopenia, anticoagulation therapy)
9. No documented allergy to ropivacaine or dexmedetomidine

Exclusion Criteria:

1. Refusal to participate in the study
2. Emergency surgery
3. American Society of Anesthesiologists class \>3
4. Left ventricular ejection fraction \<40%
5. Infection at the site of injection for ultrasound-guided ESPB
6. Coagulation disorders
7. Documented allergy to ropivacaine or dexmedetomidine
8. Greater than first-degree heart block
9. Bradycardia (heart rate \[HR\] \< 50 bpm)
10. Pregnancy
11. BMI ≥40
12. Psychiatric illnesses that would interfere with the assessment of pain scores
13. History of alcohol or drug abuse and chronic analgesic use

Primary outcomes:
measure: Analgesia time
timeFrame: 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:
measure: Total intraoperative opioid
timeFrame: Intraoperatively
measure: Total amount of rescue analgesics used
timeFrame: Postoperatively until 48 hours post-extubation
measure: Pain score
timeFrame: Postoperatively until 48 hours post-extubation
Other outcomes:
measure: Time to extubation
timeFrame: Perioperative
measure: Time to first incentive spirometry use
timeFrame: Perioperative
measure: Time to ambulation
timeFrame: Perioperative
measure: Total length of ICU stay
timeFrame: Perioperative
measure: Sedation score
timeFrame: Perioperative
Locations:
Study officials:
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