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

NCT06981949 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2025-05-21

No results posted yet for this study

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.

Conditions

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

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

Sponsors & Collaborators

  • Lebanese American University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-15
Primary Completion
2026-05-15
Completion
2026-05-16
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06981949 on ClinicalTrials.gov