Total Intravenous Anesthesia With Propofol vs. General Anesthesia in Outpatient Shoulder Arthroscopic Surgeries (TIVA)

A Prospective Clinical Trial Comparing General Anesthesia With Interscalene Nerve Block vs. Deep Sedation Via TIVA-P With Interscalene Nerve Block in Outpatient Shoulder Arthroscopies

This study is comparing total intravenous anesthesia with propofol with a regional nerve block against general anesthesia with a regional nerve block on the primary endpoint of time to meet discharge criteria.

Study Overview

• Status: Enrolling by invitation
• Conditions: Rotator Cuff Injuries; Anesthesia; Orthopedic Disorder; Rotator Cuff Tears; Sports Injury
• Intervention / Treatment: Drug: TIVA with Propofol; Drug: Inhaled Anesthesia

Detailed Description

The primary objective of this study is to determine if using Total Intravenous Anesthesia with Propofol (TIVA-P sedation) with a regional nerve block will decrease the time to meet discharge criteria. This will be done with patients undergoing shoulder arthroscopic procedures at the Roanoke Ambulatory Surgical Center. Currently, inhaled general anesthesia (GA) with a regional nerve block is utilized for these outpatient arthroscopic procedures. This involves the patient receiving Propofol through an IV to put a patient to sleep, followed by intubation (breathing tube in throat) and the administration of inhaled anesthesia for the duration of the procedure. Another approach for anesthesia in these procedures is TIVA-P sedation. In this protocol the patient receives the same initial amount of Propofol through the IV as they would if they were getting general anesthesia. Once they are asleep, it is maintained with a continuous intravenous administration of Propofol. With this approach, the patient is not intubated and exposed to the same anesthetic agents as general anesthesia. As a result, the patient may not experience the potential side effects associated with general anesthesia. We believe that this will lead to a faster time to meet discharge criteria and also fewer of anesthetic side effects.

• Study Type: Interventional
• Enrollment (Anticipated): 192
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Roanoke, Virginia, United States, 240176
      • Carilion Clinic Institute of Orthopedics and Neurosurgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18-75 years of age
• Candidate for a shoulder arthroscopic procedure in the beach chair position

Exclusion Criteria:

• American Society of Anesthesiologists (ASA) level 4 or above
• History of brachial plexus injury
• Chronic Obstructive Pulmonary Disorder
• Unstable Asthma
• BMI greater than 40
• Allergy to local anesthesic (bupivacaine)
• Contralateral phrenic nerve impairment
• History of Difficult Airway
• Poorly Controlled Gastroesophageal Reflux Disease
• Known Aspiration Risk
• Surgery not performed at the Roanoke Ambulatory Surgical Center
• Pregnant patients or patients who have a positive pre-operative human chorionic gonadotropin (beta-HCG) pregnancy test
• Coagulopathies
• Allergy to propofol
• Patient request for specific anesthesia method

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: TIVA-Propofol; Intravenous anesthesia with Propofol	Drug: TIVA with Propofol; Total intravenous anesthesia with propofol; Other Names: Propofol
ACTIVE_COMPARATOR: Inhaled Anesthesia; General Inhaled Anesthesia	Drug: Inhaled Anesthesia; General anesthesia given with inhaled anesthetics; Other Names: General Anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to meet discharge criteria	How long it takes until the patient is ready to be discharged from the PACU	Immediately after the intervention/procedure/surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scale	Pain measured via pain scale: 0 through 5. 0 is no pain, 5 is worst pain ever felt.	Baseline, pre-intervention/procedure/surgery, and up to 21 days after procedure.
Number of procedures requiring anesthetic intervention during surgery	Use of preoperative interventions including vasopressors, antiemetics, sedatives	During the intervention/procedure/surgery
Satisfaction scale	How satisfied the patient is with their treatment, scale is rated "1-Poor, 2-Average, 3-Good, 4-Excellent" with higher numbers equating to more patient satisfaction.	Up to 21 days after procedure.
post-anaesthesia care unit (PACU) I to post-anaesthesia care unit (PACU) II transition time	The amount of time it takes to go from PACU I to PACU II	Immediately after the intervention/procedure/surgery
Antiemetic use in PACU	Counting dosage of antiemetic use in PACU.	Immediately after the intervention/procedure/surgery
Surgical time	Time patient is in surgery.	During the intervention/procedure/surgery

Collaborators and Investigators

• Sponsor: Carilion Clinic
• Investigators: Principal Investigator: John Tuttle, MD, MS, Carilion Clinic Ortho Surgeon

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 2, 2021
• Primary Completion (ANTICIPATED): August 1, 2023
• Study Completion (ANTICIPATED): August 1, 2023

Study Registration Dates

• First Submitted: February 22, 2021
• First Submitted That Met QC Criteria: March 8, 2021
• First Posted (ACTUAL): March 11, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries; Wounds and Injuries; Musculoskeletal Diseases; Athletic Injuries; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Hypnotics and Sedatives; Anesthetics; Propofol
• Other Study ID Numbers: IRB19-471

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be collected, de-identified, and published in a manuscript once the study is completed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No