Effective Pain Management During Shoulder Replacement Surgery With EXPAREL

TriHealth

Status and phase: Withdrawn; Phase 4

Conditions: Shoulder Osteoarthritis; Pain, Postoperative

Treatments: Other: continuous infusion of ropivacaine interscalene nerve block; Drug: local infiltration of liposomal bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03474510

17-025

Details and patient eligibility

About

The purpose of this study is to examine the effectiveness of post-operative pain control of local infiltration (LIA) of EXPAREL administration to ropivacaine administered via continuous interscalene nerve block (CINB) for postoperative pain relief following shoulder replacement. Effectiveness will be measured in opioid consumption and NRS pain intensity scores from 0-4h, 4-8h, 9-12h, 13-16h, 17-20, 21-24h, 48 hours and 72 hours post-op. Patient satisfaction with pain control; patient functional outcome; adverse events related to CINB, EXPAREL administration, and opioid consumption; and pain intensity scores from the time of surgery until post-operative day 10 (+/- 5 days) will also be examined.

Full description

Shoulder replacement surgery is recognized as having the potential to cause a considerable amount of pain that may require opioid consumption for several days post-operatively. The side effects of opioids are numerous, and ropivacaine administered pre-operatively via interscalene nerve block, with a post-operative continuous ropivacaine infusion through an indwelling catheter (CINB) is a highly effective method for controlling pain and reducing opioid consumption and side effects. While CINB provides adequate post-operative analgesia, and may extend post-operative pain relief for up to 48 hours, there are some risks associated with CINB ranging from catheter tip withdrawal to more serious complications including catheter tip beakage, brachial plexus injury, and pulmonary complications. Local infiltration of liposomal bupivacaine (EXPAREL Pacira Pharmaceuticals, Inc., Parsippany, New Jersey) may provide longer-lasting pain relief when compared to single shot INB (SSINB), and reduce opioid consumption at 24 hours, 48 hours and 72 hours post-op. Studies have shown inconsistency in the effectiveness of EXPAREL, and one proposed reason is the method of administration. Clinicians experienced in their infiltration technique demonstrated greater improvement in pain-related outcomes. The first 48 hours post-op present the most likely opportunity for reducing narcotic administration, which increases the value of attempting to reduce opioid consumption during this period. The cost of EXPAREL LIA, is slightly less than the cost of CINB, and if pain control is comparable, may benefit the patient in reducing hospital costs. The purpose of this study is to examine the effectiveness of pain control of local infiltration of EXPAREL administration to ropivacaine administered via continuous interscalene nerve block (CINB) for postoperative pain relief following shoulder replacement. Effectiveness will be measured in opioid consumption and NRS pain intensity scores from 0-4h, 4-8h, 9-12h, 13-16h, 17-20, 21-24h, 48 hours and 72 hours post-op. Patient satisfaction with pain control; patient functional outcome; adverse events related to CINB, EXPAREL administration, and opioid consumption; and pain intensity scores from the time of surgery until post-operative day 10 (+/- 5 days) will also be examined.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Surgical candidate for primary total shoulder replacement or reverse total shoulder replacement
• Patient must be 18 years or older
• Patient must be willing and able to sign IRB approved informed consent form, and must be able to understand and agree to follow study protocol.

Exclusion criteria

• Severe bronchopulmonary disease
• Oxygen dependent
• Existing nerve injury
• BMI > 40
• Coagulation disorders
• Allergy to ropivicaine or bupivacaine
• History of drug or alcohol abuse
• Opioid use within 3 days prior to surgery
• ASA physical status > lll
• Discharge plan to Skilled nursing facility
• Pregnant women
• Non-English speaking patients

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

EXPAREL

Experimental group

Description:

Those patients randomized to receive LIA of EXPAREL will have 266mg EXPAREL diluted to 100mL, and drawn into (5) 20mL syringes affixed with (5) 22-gauge needles. Investigators will administer the syringes to the tissue in small increments with the plunger held steady while withdrawn from the tissue to avoid saturating the area around the needle sticks since EXPAREL doesn't readily travel through the tissue.

Treatment:

Drug: local infiltration of liposomal bupivacaine

interscalene nerve block

Active Comparator group

Description:

Patients will then receive 0.2% preservative-free ropivacaine at 8mL/hr beginning at the conclusion of surgery and delivered for approximately 50 hours (or finish of 400mL) via elastomeric infusion system (OnQ Pain Relief System: Select A Flow, Kimberly-Clark Corporation, Roswell, Georgia). Patients are instructed prior to discharge how to pull the catheters at home. Patients may also return to surgeon's office for catheter removal once the pain ball is empty if they prefer.

Treatment:

Other: continuous infusion of ropivacaine interscalene nerve block