Clinical trial

Evaluating General Anesthesia With Erector Spinae Plane Block vs. Spinal Anesthesia With Erector Spinae Plane Block in Lumbar Decompression Surgeries

Name

2020-2478

Description

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.

Trial arms

Trial start

2022-03-22

Estimated PCD

2024-09-27

Trial end

2024-09-27

Phase

Early phase I

Treatment

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.

Arms:

GA + ESP Block

Other names:

GA + ESP

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.

Arms:

SA + ESP Block

Other names:

Erector Spinae Block

Size

142

Primary endpoint

QoR15 survey scores

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

Eligibility criteria

Inclusion Criteria: * Patients from the ages 18- 80 years * Patients with one or two-level microdiscectomy, laminotomy, or foraminotomy - prior spine surgery is allowed only if surgery was preformed at other levels. * Able to follow study protocol * Able to provide informed consent Exclusion Criteria: * Surgery with planned need for postoperative surgical drain. * Allergies of contraindication to any study anesthetic or analgesic medications. * Morbid obesity, defined as BMI \> 35 kg/m2. * Involved in the study of another investigational product that may affect the outcome.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 142, 'type': 'ESTIMATED'}}

Updated at

2023-10-17

1 organization

2 products

3 indications

Organization

Hospital for Special Surgery

Product

Indication

Indication

Indication

Product