Erector Spinae Plane Block vs Local Infiltration Following Fusion Surgery (NCT06199999) | Clinical Trial Compass
CompletedPhase 2
Erector Spinae Plane Block vs Local Infiltration Following Fusion Surgery
United States29 participantsStarted 2024-05-15
Plain-language summary
The proposed intervention will examine two alternative methods for postoperative pain control. Two treatment arms of this study will include subjects who receive an erector spinae block (ESP) after induction of anesthesia but prior to the start of surgery and subjects who will receive a high volume of local anesthetic infiltration at the end of the procedure before emergence from anesthesia. The control group of subjects will undergo spinal surgery with general anesthesia but without any regional anesthesia. Outcome measurements include evaluation of serum inflammatory markers, pain scores, opioid usage and standardized evidence-based assessment methodologies.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Age: Greater than 18 years but less than 80
✓. Surgical procedure: 1 to 2 level thoraco-lumbar fusion between T8 and S2; non-emergent surgery
✓. Opioid naive (less than 6 oxycodone/day or 30 mg oxycodone equivalent)
✓. No contraindication to local anesthetics or regional procedures.
Exclusion criteria
✕. Emergency surgery
✕. Allergy to study medications
✕. BMI less than 20 or greater than 50
✕. Major liver or kidney dysfunction or other pre-existing major organ dysfunction
✕. Revision surgery
✕. Opioid tolerant (60 mg morphine equivalents/day for 1 week) or narcotic dependence (opioid intake morphine equivalent greater than10 mg/day for more than 3 months)
What they're measuring
1
Comparison of Quality of Recovery (QoR-15) Scores Between Treatment Groups
Timeframe: Change from pre-operation score to 1 day after surgery date
2
Quantitate the Change in Delirium Symptoms; Pre- to post-operative day 1
Timeframe: Change from pre-operation score to 1 day after surgery date