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

NCT06981949 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: LAUMCRH.CC1.23/Apr/2025
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

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. 1.Group R: Receives ropivacaine alone in the ESPB.
2. 2.Group RD: Receives ropivacaine with dexmedetomidine.
3. 3.Pain scores monitored for up to 48 hours post-extubation
4. 4.Total intraoperative opioid use
5. 5.Time to extubation, ambulation, and incentive spirometry use
6. 6.ICU stay duration
7. 7.Side effects such as nausea, bradycardia, or local anesthetic toxicity

Conditions

Pain; Pain Management Following Cardiopulmonary Bypass Surgery; Erector Spinae Plane Block

Outcome Measures

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".

  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 (3)

• Total intraoperative opioid

  Intraoperatively

• Total amount of rescue analgesics used

  Postoperatively until 48 hours post-extubation

• Pain score

  Postoperatively until 48 hours post-extubation

Other Outcomes (5)

• Time to extubation

  Perioperative

• Time to first incentive spirometry use

  Perioperative

• Time to ambulation

  Perioperative

Study Arms (2)

Group Ropivacaine Only (R)

ACTIVE COMPARATOR

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.

Drug: Ropivacaine

Group Combination Ropivacaine and Dexmedetomidine (RD)

EXPERIMENTAL

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.

Drug: Dexmedetomidine

Interventions

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)

Group Combination Ropivacaine and Dexmedetomidine (RD)

Ropivacaine DRUG

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

Group Ropivacaine Only (R)

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lebanese American University: lead

MeSH Terms

Conditions

Pain

Interventions

Dexmedetomidine; Ropivacaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Caroline Chahine, MD

CONTACT

+ 961 1 200800; caroline.chahine@lau.edu.lb

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Instructor of Medicine

Study Record Dates

• First Submitted: May 3, 2025
• First Posted: May 21, 2025
• Study Start: May 15, 2025
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): May 16, 2026
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After the publication of the study manuscript.
• Access Criteria: Researchers will be able to access the IPD and supporting information mentioned above only with a reasonable request. After assessment and in the case of approval, a data sharing agreement must be made between the study PI, the study institutional review board, and the researcher/entity requesting the de-identified dataset.