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

PHASE3Enrolling by invitationINTERVENTIONAL
Enrollment

142

Participants

Timeline

Start Date

March 22, 2022

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2026

Conditions
Lumbar Disc HerniationLumbar Disc DiseaseLumbar Radiculopathy
Interventions
DRUG

General anesthetic

"Maintenance of general anesthesia: propofol infusion (50-150 μg.kg.min-1); ketamine infusion (up to 50 mg total); and inhaled anesthetic agent (isoflurane or sevoflurane) up to 0.5 MAC. N20 is not permitted.~Emergence from general anesthesia: N20 may be used during closure of the surgical incision to facilitate rapid emergence."

DRUG

SA + ESP

"The choice of local anesthetic for spinal anesthesia will be confirmed after consultation with the attending surgeon to determine duration of surgery. For expected surgical times less than 90 minutes, up to 4 mL 1.5% mepivacaine (60 mg) will be used. Where the anticipated surgical duration is longer than 90 minutes, 2 mL 0.5% bupivacaine (10 mg) may be substituted. After patient (prone) positioning, maintenance of sedation will be achieved with a target RASS score of 0 to -1.~Propofol (25-50 μg.kg.min-1) and ketamine (up to 50 mg total dose) infusions will be titrated to effect. Intermittent boluses of propofol (10-20mg) may be used to achieve the desired sedation, as needed.~Patients will be offered to option of awake surgery, where no sedation will be provided, if preferred. Patients will be informed that at any time before or during the procedure, they may change their mind, and receive sedation."

Trial Locations (1)

10021

Hospital for Special Surgery, New York

All Listed Sponsors
lead

Hospital for Special Surgery, New York

OTHER