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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age25-80
SponsorLebanese American University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Age range: 25 - 80 years old

Planned for elective OFF PUMP CABG

Cognitively not impaired

American Society of Anesthesiologists class 3

Disqualifiers

Refusal to participate in the study

Emergency surgery

American Society of Anesthesiologists class >3

Left ventricular ejection fraction <40%

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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)

  • Ropivacaine

    Drug

    Ropivacaine only in the Bilateral single-shot Ultrasound-guided Erector Spinae Plane Block: 20ml/side of 0.375% ropivacaine

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Group Ropivacaine Only (R)Active comparator 1 intervention
Group B: Group Combination Ropivacaine and Dexmedetomidine (RD)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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".

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 outcomes

1

Total intraoperative opioid

Total intraoperative opioid usage in terms of morphine equivalent

Time frame
Intraoperatively
2

Total amount of rescue analgesics used

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
3

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."

Time frame
Postoperatively until 48 hours post-extubation

Other outcomes

1

Time to extubation

Time frame
Perioperative
2

Time to first incentive spirometry use

Time frame
Perioperative
3

Time to ambulation

Time frame
Perioperative
4

Total length of ICU stay

Time frame
Perioperative

Locations

This trial has no locations.

Sponsors and contacts

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Lebanese American University

Lead sponsor

Lebanese American University Medical Center

Sponsor institution

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