Hand Holding During Light Sedation for Minimally Invasive Spine Surgery Improves Outcomes (HHLS)

Lifespan

Status: Unknown

Conditions: Minimally Invasive; Spine

Treatments: Behavioral: Intraoperative Hand Held

Study type: Interventional

Funder types: Other

Identifiers

NCT05058079

1678933

Details and patient eligibility

About

The investigators want to determine whether handholding improves patient satisfaction and reduce patient's anxiety during minimally invasive outpatient spine surgery with monitored anesthesia care.

Full description

Minimally invasive spine interventions have emerged as a treatment options for patients with previous spine surgery and patients who have never before been operated upon. These procedures can be done safely in patients with advanced comorbid conditions, previous failed major spine procedures, and in patients who have decided to try the least invasive approach to address their lumbo-sacral spine condition in hopes of avoiding more major and potentially morbid procedures. These endoscopic procedures are typically done as outpatients with light sedation, ideally rendering the patient calm but completely cooperative and able to respond in real-time to questions from the surgeon during the procedure. This has implications for the progress and success of the procedure, the safety of the procedure and allows for a short ambulatory hospital stay.

Hand holding has been shown to improve outcomes such as compliance, procedural success and patient comfort with patients undergoing light sedation for a variety of procedures. The purpose of this study is to determine whether adding hand holding to light sedation for minimally invasive spine procedures has a positive impact on patient satisfaction and perioperative outcomes.

Enrollment: 154 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• American Society of Anesthesiology physical status 1 to 3
• Outpatient endoscopic spine procedures under light sedation

Exclusion criteria

• American Society of Anesthesiology physical status 4 or greater
• Pre-existing neuropathy
• Infection at the site
• Pregnancy
• Patient's refusal or inability to consent

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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154 participants in 2 patient groups

Hand-held group

Active Comparator group

Description:

Patients hand will be held by the anesthesia provider during the procedure. A folded blanket will be over the patient's hand during the procedure and the anesthesia provider will have their hand under the folded blanket holding the patient's hand.

Treatment:

Behavioral: Intraoperative Hand Held

No hand holding group

No Intervention group

Description:

No physical contact for comfort or reassurance during the procedure. A folded blanket will be over the patient's hand during the procedure and the anesthesia provider will be next to the patient's hand.