A clinical trial to study the effect of a drug dexmedetomidine as adjuvant to local anaesthetic drug ropivacaine using ultrasound guided fascial plne block named erector spinae plane block in patients posted for cardiac surgery

Ultrasound-guided erector spinae plane block using dexmedetomidine as an adjuvant to ropivacaine versus ropivacaine alone analgesia in cardiac surgical patients: a prospective double blind randomized controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/07/055501

Enrollment

Registered

2023-07-21

Start date

Unknown

Completion date

Unknown

Last updated

2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I998- Other disorder of circulatory system

Interventions

Intervention1: using ULTRASOUND GUIDED ERECTOR SPINAE PLANE BLOCK comparing ropivavaine 0.375% vs ropivacaine 0.375 with dexmedetomidine as adjuvant: Patient will be turned to left lateral decubitus p

20 ml on each side. Group RD: This group will receive single-shot bilateral ESP block with 40 ml 0.375% ropivacaine containing 1mcg/k

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria will be adult cardiac surgical patients aged 18 to 65 years undergoing elective cardiac surgery.

Exclusion criteria

Exclusion criteria: Exclusion criteria will be as follows: 1. Patient refusal 2. Deranged coagulation profile 3. Spine deformity 4. Local skin infection 5. Baseline HR 6. Hepatic or renal insufficiency 7. Significant left main disease 8. Severe LV systolic dysfunction (LVEF 9. Patients weighing 70kg 10. Hemodynamically unstable patient 11. Patients requiring >24 hrs mechanical ventilation

Design outcomes

Primary

Measure	Time frame
PRIMARY OUTCOME: Total fentanyl consumption (intraoperative & postoperative) in 24 hrs.Timepoint: PRIMARY OUTCOME: Total fentanyl consumption (intraoperative & postoperative) in 24 hrs.	—

Secondary

Measure	Time frame
SECONDARY OUTCOME: 1. Duration of postoperative pain relief defined as time in minutes to first rescue analgesia (1mic/Kg fentanyl) when VAS 4 or patient demands analgesia. 2. Incidence of Operating room extubation 3. Change in mechanical ventilation duration 4. Changes in VAS at every 6hrly till 24 hours since administration of block. 5. Incidence of adverse events: Hypotension & bradycardia Timepoint: for 24 hrs	—

Measure

Time frame

SECONDARY OUTCOME: 1. Duration of postoperative pain relief defined as time in minutes to first rescue analgesia (1mic/Kg fentanyl) when VAS 4 or patient demands analgesia. 2. Incidence of Operating room extubation 3. Change in mechanical ventilation duration 4. Changes in VAS at every 6hrly till 24 hours since administration of block. 5. Incidence of adverse events: Hypotension & bradycardia Timepoint: for 24 hrs

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Countries

India

Contacts

Public ContactIra Dhawan

Post graduate institute of medical education and research(PGIMER)

driradhawan14@gmail.com01722755065

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026