Clinical trial NCT03069677: Music vs Midazolam During Preop Nerve Block Placement
Official title: Music vs Midazolam During Preoperative Nerve Block Placement: A Prospective, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anxiety
Peripheral Nerve Block
Keywords: midazolam
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2017-03-03
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if there are differences in anxiety scores, heart rate, blood pressure, and oxygen status when using sedation medication versus music while undergoing a peripheral nerve block before your surgery.

Detailed description: The general flow of the study will be conducted as follows:

1. Research coordinator will call or approach patients who are scheduled for a surgical procedure that is planning for a peripheral nerve block either for the primary anesthetic or for postoperative pain control to be placed in the preoperative bay in the ambulatory surgical center.
2. Research coordinator will discuss the purpose of our study and explain the study in detail for the patient. If a patient agrees to participate, then we will have the patient sign the informed consent for the study. If patient is on the phone and decides to participate, the patient will sign the informed consent upon arriving to Penn Medicine University City (PMUC).
3. Once the patient signs the informed consent for the peripheral nerve block by anesthesia team. The patient randomized will be revealed to either music or IV midazolam. The pre-procedure anxiety score will then be obtained using the STAI-6 validated tool.
4. The golden moment will be conducted between the patient, provider, and nursing staff. Once this golden moment is completed, the anxiolytic intervention will start (music or IV midazolam)\*
5. The preoperative nerve block will be conducted by the regional anesthesia block team.
6. Once the nerve block is complete, we will obtain the post-procedure anxiety score using the STAI-6 validated tool.
7. Once the post-procedure anxiety score has been obtained, we will also obtain the patient satisfaction score, the provider satisfaction score, and the evaluation of any difficulties in communication between the provider and patient. After these questions have been obtained, the study is complete.

Eligibility criteria: Inclusion Criteria:

* Patients who are \>18 years of age, who will give informed consent in receiving a peripheral nerve block in the preoperative bay for their primary anesthetic and/or for their postoperative pain control.

Exclusion Criteria:

* significant psychiatric disorder such as generalized anxiety disorder, panic disorder, depression, psychosis, bipolar disorder; individuals who were incompetent to give informed consent; pregnant and/or breast feeding patients; any underlying coagulopathy, infection or other factors which would be a contraindication to receiving a peripheral nerve block; hypersensitivity to midazolam; and history of renal impairment. Patients who were extremely anxious (scores 50 and greater on the State Trait Anxiety Inventory-6 (STAI-6) tool) were also excluded from the study.

Primary outcomes:
measure: Anxiety Levels
timeFrame: 1-2 minutes before conducting golden moment for nerve block placement and immediately after nerve block placement (less than 1 minute after)
measure: Change in STAI-6 Scores From Post to Pre.
timeFrame: 1-2 minutes before conducting golden moment for nerve block placement and immediately after nerve block placement (less than 1 minute after)
Secondary outcomes:
measure: Patient Satisfaction Scores of the Experience During Procedure
timeFrame: immediately after nerve block placement (less than 1 minute after)
measure: Provider Satisfaction Scores of the Experience During Procedure
timeFrame: immediately after nerve block placement (less than 1 minute after)
measure: Evaluation of Difficulties in Communication From Provider to Patient and Patient to Provider
timeFrame: immediately after nerve block placement (less than 1 minute after)
measure: Block Times
timeFrame: immediately after nerve block placement (less than 1 minute after)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania, Anesthesia
name: Veena Graff, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Graff V, Cai L, Badiola I, Elkassabany NM. Music versus midazolam during preoperative nerve block placements: a prospective randomized controlled study. Reg Anesth Pain Med. 2019 Jul 18:rapm-2018-100251. doi: 10.1136/rapm-2018-100251. Online ahead of print.