Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Age â?? 18 to 65 years, Either gender, ASA grade I to III, Elective spine surgeries in prone position involving up to 4 vertebral levels and lasting up to 6 hours
Exclusion criteria
Exclusion criteria: Surgeries involving C1 and C2 levels, Spine tumors requiring TIVA and neuromonitoring, Any contraindications to regional block such as local infections or allergy to local anesthetics, Refusal of consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the intraoperative opioid consumption and acute postoperative pain (up to 48hours) in patients undergoing spine surgeries with and without ESP blockTimepoint: 48hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Measures of nociception between the 2 groups using Surgical Pleth Index, and systemic hemodynamics (heart rate and mean blood pressure)Timepoint: every 15min during the surgery;To assess surgical stress between the 2 groups using Biomarkers (cortisol, glucose, leucocytes count)Timepoint: Immediately before and after surgery;To compare adverse events related to analgesia techniques till 48 h after surgery [Pruritus, urinary retention, PONV, delayed recovery from anaesthesia, etc. related to opioid and hypotension, pneumothorax related to ESP block]Timepoint: upto 48 hours after surgery;To compare chronic pain between 2 groups at 3 months after surgery by telephonic interview [intensity, need and response to analgesics and effect of pain on quality of life and return to work]Timepoint: at 3months after surgery;To compare quality of sleep between the two groups using Likert sleep scaleTimepoint: On postoperative day 1 and day 2;To compare rescue analgesic requirements between the 2 groups postoperativelyTimepoint: Up to 48 h after surgery | — |
Countries
India
Contacts
NIMHANS