Effective Pain Management During Shoulder Replacement Surgery With EXPAREL
| Status: | Recruiting |
|---|---|
| Conditions: | Osteoarthritis (OA), Post-Surgical Pain |
| Therapuetic Areas: | Musculoskeletal, Rheumatology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/25/2018 |
| Start Date: | March 17, 2018 |
| End Date: | December 12, 2019 |
| Contact: | Alex Sympson, BA |
| Email: | alexandra_sympson@trihealth.com |
| Phone: | 513-862-1904 |
Effective Pain Management During Shoulder Replacement Surgery With Either Continuous Ropivacaine Interscalene Nerve Block or Local Infiltration With EXPAREL After Single Shot Injection Ropivacaine Interscalene Nerve Block
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.
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.
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.
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.
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
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