Measuring Opioid Use After Rotator Cuff Repair: Comparing the Effects of Standard vs. Extended-release Nerve Blocks

Patients who have an Arthroscopic Rotator Cuff Repair (ARCR) scheduled to be performed at Roanoke Ambulatory Surgery Center (RASC) by one of the participating surgeons will be prescreened, assessed for eligibility and consented at the pre-operative visit.

• This office visit already includes: a formatted discussion regarding the risks, benefits and alternatives to surgery; fitting for a sling; and a review of the opioid policy and patient agreement used by Carilion Clinic's Institute for Orthopaedics and Neurosciences (ION).
• The PI or sub-investigators will conduct the discussion regarding the rational and use of Interscalene Brachial Plexus Block (ISB) with the procedure, the rationale for assessment of alternate medications used for the study and any other pertinent details. An approved research team member will review all sections of the IRB approved research consent in detail, in person at the pre-operative visit. All questions will be answered and physical signatures will be obtained. Both research groups, control and experimental, will sign the same consent document. A copy of the signed consent will be provided to the participant.

All participants will be given a pain diary to take home and begin filling out the day following their surgery. Per participant preference, pain diary may be physical copy or done electronically via REDCap.

• All participants will be instructed on how to record entries in the pain diary by an approved research team member. The pain diary will have templated pages with areas to record the amounts and names of medications they consumed, their Numerical Rating Scale (NRS) score, their Intervention Based Pain Scale (IBPS) score, as well as satisfaction levels and a place to record how long their anesthetic block lasted.

Participants in both study groups will be provided the same information and education regarding postoperative pain management protocol and expectations. This includes:

• A review of the opioid policy and patient agreement used by Carilion Clinic's ION as well as a discussion about proper use of the pain medication to be prescribed for postoperative pain management
• A discussion regarding the ISBs used with the procedure and their likely duration of analgesia
• A discussion of scheduled postoperative visits and how to contact the office with questions/concerns regarding recovery

In the pre-operative holding area or the operating room, the anesthesiologist will position all participants in the recumbent position with a slight roll onto the opposite side from the block and will administer a local infiltration of the skin with 1-2mL of Bupivacaine HCl 0.5% (dosages may vary based on participant size and pain threshold). If participants are unable to sit still during ISB administration, they may be sedated by the anesthesiologist with one of the following (Medications and dosages vary based on need):

• Versed
• Fentanyl
• Propofol

Administration of the standard Bupivacaine HCl ISB for the control arm goes as follows:

• After proper positioning and local infiltration, a linear high-frequency ultrasound transducer will be placed on the anteromedial aspect of the neck, approximately 2 cm above the clavicle, and the interscalene brachial plexus will be identified between the anterior and middle scalene muscles. After sterile preparation of the skin, a 22-gauge block needle will be inserted in-plane from the lateral aspect of the transducer and directed through the middle scalene muscle. The needle will be advanced until the tip is observed just lateral to the brachial plexus sheath. After negative aspiration, 20mL of 0.5% bupivacaine will be injected in 5mL increments, followed by 20mL of 0.25% bupivacaine injected in 5mL increments. The injection will be administered slowly with periodic aspiration, with the needle being adjusted using ultrasound guidance as the ISB is injected to surround the brachial plexus trunks (upper, middle and lower) that are seen at the interscalene level of injection. There will be only one injection site.

Administration of the Exparel ISB for the experimental arm goes as follows:

• After proper positioning and local infiltration, a linear high-frequency ultrasound transducer will be placed on the anteromedial aspect of the neck, approximately 2 cm above the clavicle, and the interscalene brachial plexus will be identified between the anterior and middle scalene muscles. After sterile preparation of the skin, a 22-gauge block needle will be inserted in-plane from the lateral aspect of the transducer and directed through the middle scalene muscle. The needle will be advanced until the tip is observed just lateral to the brachial plexus sheath. After negative aspiration, 20mL of 0.5% bupivacaine will be injected in 5mL increments, followed by 20mL of Exparel injected in 5mL increments. The injection will be administered slowly with periodic aspiration, with the needle being adjusted using ultrasound guidance as the ISB is injected to surround the brachial plexus trunks (upper, middle and lower) that are seen at the interscalene level of injection. There will be only one injection site.

15-20 minutes after administration of ISBs (Bupivacaine HCl or Exparel), all participants will be put under general anesthesia (if not already) by the anesthesiologist with one of the following (Medications and dosages vary based on patient need. Most common medications used listed below):

• Versed
• Fentanyl
• Propofol

After general anesthetic takes effect, all participants will be operated on by their fellowship-trained orthopaedic surgeon.

• During the operation, all participants may receive an intravenous injection of Toradol (15-30 mg based on weight and renal function)

All participants will be discharged with post-operative pain medications regimens based on department protocol and physician preference.

• Oral Opioid Medication: 5mg/325mg hydrocodone/acetaminophen q4-6h prn pain
• Non-Opioid Pain Medication: 10mg Toradol q8h prn pain 5 days maximum

All participants will fill out a pain diary during the first 2 weeks postoperatively that will assess 5 measures.

• Medication consumption (dose \& number of pills) - will be asked to record daily
• Pain score on the NRS - will be asked to record daily
• Pain score on an institutional IBPS - will be asked to record daily
• Patient satisfaction - will be asked to record daily
• Nerve block duration - will be reminded to record if their block has worn off, and if so, how many hours it was effective (until they regained sensation).

All participants will be called before their 2- and 6-week follow-up appointments and will be asked to bring in their pain diaries as well as their opioid medication pill bottles to their visit so that pill counts may be conducted.

• All calls will be made by trained, authorized site delegates. There will be a locked drop-box in the ION building where participants can drop off their pain diaries after their 2-week follow-up appointment if they forget to bring it in to their appointment.

All participants will come into the office for 2 follow up appointments, at 2 and 6 weeks postoperatively.

• At the 2-week postoperative visit, all participants will be expected to bring in their opioid medication pill bottles and pain diaries per instructions given at study enrollment and on the reminder phone call. All participants will be shown where the lock boxes are to deposit pain diaries. Pill counts will be conducted and recorded as well as number of refills.
• At the 6-week postoperative visit, all participants will be expected to bring in the opioid medication pill bottles per instructions given at study enrollment and on the reminder phone call.
• Pill counts will be conducted and recorded as well as number of refills.