Clinical trial NCT05610969: Music vs Midazolam During Preop Nerve Block Placement - Part 2 Study On Anxiolytic Options Before Peripheral Nerve Blocks
Official title: To Serenade or To Sedate? That is Still The Question - A Followup Trial On Anxiolytic Options Before Peripheral Nerve Blocks
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Peripheral Nerve Block
Anxiety
Preoperative Anxiety
Keywords: Midazolam
Adjuvants, Anesthesia
Anti-Anxiety Agents
Hypnotics and Sedatives
Tranquilizing Agents
Anesthetics
GABA Modulators
GABA Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Neurotransmitter Agents
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2022-11-09
Enrollment: 36
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: This study is evaluating music vs midazolam as a means of anxiolysis for preoperative single-shot nerve block placement.

Detailed description: Preoperative anxiety is common and can adversely affect a patient's perioperative course by elevating stress markers, promoting fluctuations in hemodynamics and negatively impacting on postoperative recovery. Preoperative anxiety is routinely treated with pharmacologic agents such as midazolam, a benzodiazepine, which has known, undesirable side effects including respiratory depression, hemodynamic perturbations, and paradoxical effects such as hostility, aggression, and psychomotor agitation. The use of sedative medications requires continuous vital sign monitoring of patients by either anesthesia or nursing personnel and there is a question of whether midazolam helps reduce pre-procedural anxiety compared with placebo. Music is a non-pharmacologic intervention that has been shown to significantly decrease preoperative anxiety. This intervention can be used as an adjunct or even replace pharmacologic agents to help with preoperative anxiety. Music is a modality that is virtually harm-free and relatively cheap in cost. Patients who are unable to tolerate pharmacologic agents to treat preoperative anxiety can greatly benefit from non-pharmacologic options such as music.

Regional anesthesia procedures such as an ultrasound guided, peripheral nerve block is a common bedside procedure done preoperatively. Patients may have some anxiety prior to the administration of this nerve block procedure and may receive sedation for it. However, it is imperative not to over sedate them as constant feedback from the patient is necessary during the procedure. Commonly, midazolam is used to reduce this anxiety, but non-pharmacologic therapies can also reduce anxiety. In our recent published study, we evaluated the use of research-selected, relaxing music, to reduce anxiety before the nerve block is administered. In this study, we used noise-canceling headphones and played research-selected music as our anxiolytic music modality and compared this with midazolam. The findings showed no difference between both groups in the change in anxiety scores from after to before the nerve block, however patients had better satisfaction in the midazolam group and increased difficulty in communication in the music group. We attributed this to not allowing patients to choose their own selection of music and the use of noise-canceling headphones.

Therefore, in this follow-up study, we aim to evaluate the use of patient-selected music via non-noise canceling headphones as a preoperative anxiolytic prior to the administration of a bedside, peripheral nerve block procedure. This study will be conducted at an ambulatory surgical center in a university setting.

Eligibility criteria: Inclusion Criteria:

* Patients who are \>18 years of age
* Patients able to 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
* history of renal impairment.
* Patients who were extremely anxious (scores greater than 50 on the State Trait Anxiety Inventory-6 (STAI-6) tool) were also excluded from the study.

Primary outcomes:
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 - Time it Took to do the Block
timeFrame: start of doing the block to 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, Anesthesiology and Critical Care
name: Veena Graff, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: