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

NCT05482113 | Completed Phase 4 FDA Drug

• 1 other identifier: 19-530
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim to determine if a longer acting nerve block, which is a local anesthetic, can help reduce opioid use after surgery in patients that are getting rotator cuff repair surgery. The investigators will also determine if the longer acting block can reduce the number of days that opioids are taken after surgery. Patients that schedule this type of surgery will be given information regarding the study and asked if they want to participate. If they do, they will be randomized to either receive the standard nerve block or the longer acting nerve block. Participants and physicians will not know which nerve block the participants are receiving. Participants will receive a standard pain medication prescription after surgery and will be asked to record pain scores, medications taken and satisfaction level every day in a journal for two weeks. Participants will be asked to bring in their medication bottles and pain journal to the 2-week follow up appointment. Participants' pain scores will be assessed in the office at the follow up appointment and study staff will conduct a pill count. Participants will return for a 6-week follow up appointment and pain scores will be assessed again at that time, and another pill count will be conducted. At this point the study will be complete.

Conditions

Rotator Cuff Tears

Keywords

randomized controlled trial; exparel; opioid use; arthroscopic rotator cuff repair; bupivacaine; liposomal bupivacaine; rotator cuff; interscalene brachial plexus block; rotator cuff tear

Outcome Measures

Primary Outcomes (4)

• Total Opioid Use

  Total opioid pills consumed, converted to milligram of morphine equivalents (MME)

  6 week

• Duration of Opioid Use

  How long the patients took opioid medications for postoperatively (in hours)

  Total 6 week duration of study

• NRS Pain Scores

  Pain scores on the Numerical Rating Scale, 1-10 with 1 being no pain and 10 being the worst pain imaginable

  Total 6 week duration of study

• IBPS Pain Scores

  Pain scores on our Intervention Based Pain Scale, proprietary scale developed by Dr. TK Miller at Carilion Clinic. Patient has 6 options to choose from (unnumbered), that will be assigned a numeric value upon analysis. Scale ranges from 1-6, with lower scores representing more manageable (less severe) pain and higher scores representing less manageable (more severe) pain.

  Total 6 week duration of study

Secondary Outcomes (2)

• Duration of Nerve Block

  Within 5 days postoperatively

• Patient Satisfaction via Likert scale

  2 weeks postoperatively

Study Arms (2)

Control - Standard Bupivacaine

ACTIVE COMPARATOR

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 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.

Drug: Bupivacaine Hcl 0.25% Inj

Experimental - Liposomal Bupivacaine (Exparel)

EXPERIMENTAL

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 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.

Drug: Liposomal bupivacaine

Interventions

Liposomal bupivacaine DRUG

Liposomal Bupivacaine (Exparel) Brachial Plexus Block for Arthroscopic Rotator Cuff Repair

Also known as: Exparel

Experimental - Liposomal Bupivacaine (Exparel)

Bupivacaine Hcl 0.25% Inj DRUG

Standard 0.25% Bupivacaine Brachial Plexus Block for Arthroscopic Rotator Cuff Repair

Also known as: Standard Bupivacaine

Control - Standard Bupivacaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age at time of enrollment
• Be scheduled for Arthroscopic Rotator Cuff Repair (ARCR) surgery with associated pathology (CPT code 29827 + associated codes)
• Be scheduled for ARCR surgery for primary repair
• Be scheduled for ARCR surgery to be performed at Roanoke Ambulatory Surgery Center (RASC) by a surgeon participating in the study
• Is willing to fill out the pain diary
• Is able to read, understand, and sign the informed consent document
• Is able to read and understand the patient-reported measures that will be collected via the pain diary and phone calls

You may not qualify if:

• American Society of Anesthesiologists (ASA) status IIIb or greater.
• ASA status III is characterized by:
• A patient with severe systemic disease, e.g., Substantive functional limitations; One or more moderate to severe diseases. Examples include (but not limited to): poorly controlled DM or HTN, COPD, morbid obesity (BMI ≥40), active hepatitis, alcohol dependence or abuse, implanted pacemaker, moderate reduction of ejection fraction, ESRD undergoing regularly scheduled dialysis, premature infant PCA \< 60 weeks, history (\>3 months) of MI, CVA, TIA, or CAD/stents.
• According to Dr. TK Miller and Anesthesiologists at RASC, there is an unwritten standard that patients characterized as ASA status III that have stable, long term disease can be operated on at free-standing ambulatory surgery centers. Broken down into ASA IIIa and ASA IIIb.
• ASA IIIa represents ASA status III patients that are assessed by anesthesia and deemed stable enough to operate on at a free-standing ambulatory surgery center.
• ASA IIIb represents ASA status III patients that are assessed by anesthesia and deemed not stable enough to operate on at a free-standing ambulatory surgery center.
• Examples of individuals that would classify as ASA IIIa include:
• Someone who has a history of longstanding diabetes that is well managed.
• Someone who is status post cardiac stent(s) and has had no chest pain or angina since the stents have been placed and has been cleared by their cardiologist to go back to full activity.
• Examples of individuals that would classify as ASA IIIb include:
• Someone who has a history of longstanding diabetes that is poorly managed.
• Someone who is status post cardiac stent(s) and has had chest pain or angina since the stents have been placed and has not been cleared by their cardiologist to go back to full activity.
• Currently pregnant
• Documented opioid use within 30 days prior to surgery
• Revision ARCR surgery

Sponsors & Collaborators

• Carilion Clinic: lead
• Virginia Polytechnic Institute and State University: collaborator

Study Sites (1)

Carilion Clinic Institute for Orthopaedics and Neurosciences

Roanoke, Virginia, 24014, United States

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Thomas K Miller, MD

  Section Chief, Sports Medicine, Carilion Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Section Chief, Sports Medicine

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: August 1, 2022
• Study Start: March 9, 2021
• Primary Completion: December 15, 2021
• Study Completion: December 15, 2021
• Last Updated: August 1, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)