drugset / Trial / NCT05444751

GA + ESP vs. SA + ESP in Lumbar Decompression Surgeries

NCT05444751

Phase 3 Enrolling by invitation 142 enrolled Hospital for Special Surgery, New York
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the optimal anesthetic routine for lumbar decompression surgery. General Anesthesia is the standard of care in spine surgery. Spinal anesthesia in decompressive procedures can be the new standard of care. Recently, it has been found that regional analgesia is option that has been shown to improve pain and opioid-related outcomes after spine surgery, but has not yet been studied in combination with spinal anesthesia. This is study that consists of two groups: standard of care general anesthesia with a nerve block and a spinal anesthesia with nerve block. Patients are randomized to either of the two groups. There will be 71 patients enrolled in each group for this study.

Timeline

Start
2022-03-22
Primary completion
2026-09
Completion
2026-09

Publications

Drugs

EvaluationDrugModalityDoseRoute
Background Bupivacaine Other / unclassified 10 mg Intrathecal
Comparator Fentanyl Other / unclassified 2 ug/kg
Comparator Isoflurane Other / unclassified 0.5 unknown Inhaled
Background Ketamine Small molecule 50 mg
Background Mepivacaine Other / unclassified 60 mg Intrathecal
Background Propofol Small molecule 25 ug/kg
Background Propofol Small molecule 50 ug/kg
Background Propofol Small molecule 150 ug/kg
Comparator Sevoflurane Other / unclassified 0.5 unknown Inhaled
Comparator Vecuronium Small molecule 1 mg/kg
Comparator Vecuronium Small molecule 2 mg/kg