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

Part of paid clinical trials in New York, New York.

Sponsor
Hospital for Special Surgery, New York
Study ID
NCT05444751
Phase
PHASE3
Status
Enrolling By Invitation

Conditions

  • Lumbar Disc Disease
  • Lumbar Disc Herniation
  • Lumbar Radiculopathy

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • General anesthetic — DRUG
    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.
  • SA + ESP — DRUG
    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.

Study Details

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.

Key Dates

Start date
Mar 22, 2022
Status verified
Jan 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
142 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SA + ESP Block
    Spinal Anesthesia: Patients will be provided with iv sedation, if desired, to facilitate placement of spinal anesthetic. Midazolam (2-5mg, iv), ketamine (up to 20 mg, lv) and/or propofol (0.1-0.2 mg/kg) will be permitted.
  • Active Comparator: GA + ESP Block
    General anesthesia: induction of general anesthesia to facilitate endotracheal intubation: fentanyl (up to 2μg.kg.min-1), propofol (1-2 mg.kg-1), vecuronium (1-2 mg.kg-1).

Primary Outcome Measure

QoR15 survey scores [ Time Frame: The QoR15 survey will be assessed preoperatively (in holding area). It will be assessed again immediately after surgery in the PACU and then at 2-weeks postoperatively at the patient's first follow-up visits ]

Locations (1)

FacilityCityStateZIPSite coordinators
Hospital for Special SurgeryNew YorkNew York10021-

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By research site
Hospital for Special Surgery· New York, NY

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