Addition of Dexmedetomidine to Ropivacaine in Bilateral Erector Spinae Plane Block in Patients Undergoing Coronary Artery Bypass Surgery

Phase 4

Not yet recruiting

• Conditions: Pain; Pain Management Following Cardiopulmonary Bypass Surgery; Erector Spinae Plane Block
• Interventions: Drug: Ropivacaine; Drug: Dexmedetomidine

• Registration Number: NCT06981949
• Lead Sponsor: Lebanese American University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-03
• Study Start: 2025-05-15
• Study First Submitted QC: 2025-05-17
• Last Update Submitted: 2025-05-17
• Study First Posted: 2025-05-21
• Last Update Posted: 2025-05-21
• Primary Completion: 2026-05-15
• Study Completion: 2026-05-16

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Ropivacaine Only (R)	Ropivacaine	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)	Dexmedetomidine	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.

Primary Outcome Measures

Name	Time	Method
Analgesia time	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".

Secondary Outcome Measures

Name	Time	Method
Total intraoperative opioid	Intraoperatively	Total intraoperative opioid usage in terms of morphine equivalent
Total amount of rescue analgesics used	Postoperatively until 48 hours post-extubation	Rescue analgesia requirements, including morphine or other than morphine, includes the total amount of each rescue analgesic used
Pain score	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."