Brief Summary
The investigators are comparing an indwelling catheter with intermediate duration local anesthetic to a single shot peripheral nerve block with long acting a local anesthetic (Exparel).
Brief Title
Exparel Interscalene vs Indwelling Catheter
Detailed Description
While placing an indwelling nerve catheter can prolong pain control, it can also have drawbacks and complications. While major complications like pneumothorax and hemidiaphragmatic paresis from interscalene continuous peripheral nerve blocks (CPNB) are rare, minor adverse effects associated with CPNBs may be more common. They include infection and anatomical damage to blood vessels and nerves due to the indwelling catheter. In addition, catheters take a significantly longer time to set up and place than single shot blocks, which is important as there is often a rush to block patients and trying to get them into the operating room on time. Furthermore, the needle used for catheter placement is larger than the single shot needles, which creates more discomfort to patients during the nerve block. The catheter itself is taped around the entire sides and back of the patient's neck, which is also uncomfortable for patients. Because of how shallow the interscalene block is, the catheter is often found to be dislodged from operating room positioning, patient transport or movement, which negates the placement of the catheter. An indwelling catheter must also be followed up by the acute pain service team until the catheter is removed.
Exparel, or liposomal bupivacaine, is formulated to release low dose bupivacaine over 96 hours, and was recently approved by the FDA in April 2018 to be used in interscalene blocks. The sustained release of local anesthetic could theoretically act similarly to the continuous infusion of local anesthetic through an indwelling interscalene catheter, and could thus avoid the need for placement of a catheter. Current existing data, although inconclusive, has in some studies shown an equal analgesic effect as catheters. As per pharmacy, the cost of the On-Q pump and the local anesthesia needed for the pump together cost $390 for each indwelling catheter placed, not including the cost of anesthesia and pharmacy supplies and labor. The cost of each 20 mL vial of Exparel is less at $285 and, for a single shot nerve block, would avoid the extra costs and time needed for a catheter placement.
The investigators would like to perform a prospective randomized controlled pilot study to examine the efficacy of single shot interscalene blocks using Exparel versus the traditional interscalene catheter used at our institution. The purpose of the study the investigators are proposing is to determine if single shot interscalene nerve blocks using Exparel can provide equivalent or better analgesia than indwelling interscalene catheter in patients who undergo total shoulder replacement surgery. If so, single shot interscalene nerve blocks with Exparel may serve as a quicker, easier, cheaper, safer, and more comfortable alternative to placing indwelling interscalene catheters.
Exparel, or liposomal bupivacaine, is formulated to release low dose bupivacaine over 96 hours, and was recently approved by the FDA in April 2018 to be used in interscalene blocks. The sustained release of local anesthetic could theoretically act similarly to the continuous infusion of local anesthetic through an indwelling interscalene catheter, and could thus avoid the need for placement of a catheter. Current existing data, although inconclusive, has in some studies shown an equal analgesic effect as catheters. As per pharmacy, the cost of the On-Q pump and the local anesthesia needed for the pump together cost $390 for each indwelling catheter placed, not including the cost of anesthesia and pharmacy supplies and labor. The cost of each 20 mL vial of Exparel is less at $285 and, for a single shot nerve block, would avoid the extra costs and time needed for a catheter placement.
The investigators would like to perform a prospective randomized controlled pilot study to examine the efficacy of single shot interscalene blocks using Exparel versus the traditional interscalene catheter used at our institution. The purpose of the study the investigators are proposing is to determine if single shot interscalene nerve blocks using Exparel can provide equivalent or better analgesia than indwelling interscalene catheter in patients who undergo total shoulder replacement surgery. If so, single shot interscalene nerve blocks with Exparel may serve as a quicker, easier, cheaper, safer, and more comfortable alternative to placing indwelling interscalene catheters.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Pain
Eligibility Criteria
Inclusion Criteria:
* American Society of Anesthesia (ASA) 1, 2, and 3
* Ages 40-74
* Patients scheduled for total shoulder replacement
Exclusion Criteria:
* ASA 4 and 5
* Pre-existing pain disorder
* Regular consumption of chronic pain medication
* pregnant women
* any medical condition such as a clotting disorder
* anatomic abnormality that precludes use of an indwelling scalene catheter
* Body Mass Index (BMI) \>40
* Patient refusal
* Pre-existing diabetic neuropathy or Hemoglobin A1c \>9
* Failed block
* American Society of Anesthesia (ASA) 1, 2, and 3
* Ages 40-74
* Patients scheduled for total shoulder replacement
Exclusion Criteria:
* ASA 4 and 5
* Pre-existing pain disorder
* Regular consumption of chronic pain medication
* pregnant women
* any medical condition such as a clotting disorder
* anatomic abnormality that precludes use of an indwelling scalene catheter
* Body Mass Index (BMI) \>40
* Patient refusal
* Pre-existing diabetic neuropathy or Hemoglobin A1c \>9
* Failed block
Inclusion Criteria
Inclusion Criteria:
* American Society of Anesthesia (ASA) 1, 2, and 3
* Ages 40-74
* Patients scheduled for total shoulder replacement
* American Society of Anesthesia (ASA) 1, 2, and 3
* Ages 40-74
* Patients scheduled for total shoulder replacement
Gender
All
Gender Based
false
Keywords
shoulder surgery, post operative pain
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
74 Years
Minimum Age
40 Years
NCT Id
NCT03827213
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2018-9707
Overall Status
Terminated
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Prospective Randomized Control Trial Evaluating Single Shot Exparel Versus Indwelling Interscalene Catheter for Total Shoulder Replacements- A Pilot Study
Primary Outcomes
Outcome Description
Participant opioid requirements at 24 hours from treatment in morphine equivalents. Will report how much pain management medication participant needed within first 24 hours post-surgery.
Outcome Measure
Opioid Requirements Assessed at 24 Hours Post-surgery
Outcome Time Frame
24 Hours post-surgery
Secondary Outcomes
Outcome Description
Opioid requirements (morphine equivalents) during surgery. Will report how much pain management medication participant needed during surgery.
Outcome Time Frame
Duration of Surgery (Approximately 3 hours)
Outcome Measure
Intra-Operative Opioid Requirements
Outcome Description
8-hour Opioid requirements (morphine equivalents). Will report how much pain management medication participant needed within first 8 hours after surgery.
Outcome Time Frame
8 hour post-surgery
Outcome Measure
Opioid Requirements Assessed at 8-hours Post-surgery
Outcome Description
Collecting patient pain scores in the Post Anesthesia Care Unit (PACU). Participant will be asked to rate their pain score from 0 (no pain) to10 (worst pain)
Outcome Time Frame
During time in PACU (up to 5 hours)
Outcome Measure
Pain Score in Post Anesthesia Care Unit (PACU)
Outcome Description
48 hour Opioid requirements (morphine equivalents). Will report how much pain management medication participant needed within first 48 hours after surgery.
Outcome Time Frame
48 hours post-surgery
Outcome Measure
Opioid Requirements Assessed at 48 Hours Post-surgery
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
74
Minimum Age Number (converted to Years and rounded down)
40
Investigators
Investigator Type
Principal Investigator
Investigator Name
Elilary Montilla Medrano
Investigator Email
emontill@montefiore.org
Investigator Phone