Pain
Conditions
Keywords
shoulder surgery, post operative pain
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).
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.
Interventions
A shot of long acting local anesthetic for post operative pain management
ropivacaine, given through a catheter inserted between the shoulders
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Requirements Assessed at 24 Hours Post-surgery | 24 Hours post-surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intra-Operative Opioid Requirements | Duration of Surgery (Approximately 3 hours) | Opioid requirements (morphine equivalents) during surgery. Will report how much pain management medication participant needed during surgery. |
| Opioid Requirements Assessed at 8-hours Post-surgery | 8 hour post-surgery | 8-hour Opioid requirements (morphine equivalents). Will report how much pain management medication participant needed within first 8 hours after surgery. |
| Pain Score in Post Anesthesia Care Unit (PACU) | During time in PACU (up to 5 hours) | 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) |
| Opioid Requirements Assessed at 48 Hours Post-surgery | 48 hours post-surgery | 48 hour Opioid requirements (morphine equivalents). Will report how much pain management medication participant needed within first 48 hours after surgery. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay | At Discharge (up to 3 days) | Number of days subjects stayed until discharge. Will report how many days participant stayed in hospital after surgery. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Shot Interscalene Nerve Block This group received an interscalene nerve block. This was administered as a single 20mL injection consisting of a mixture of 10mL of Exparel and 10mL of 0.5% bupivacaine hydrochloride. | 11 |
| Indwelling Interscalene Catheter This group received an indwelling interscalene catheter placed posterior to C5-C6 nerve roots (between the shoulders) and administered 15 mL of 0.5% ropivacaine plain for the block with no superficial cervical block. The On-Q pump was set at a rate of 4 mL/hr. | 12 |
| Total | 23 |
Baseline characteristics
| Characteristic | Indwelling Interscalene Catheter | Total | Single Shot Interscalene Nerve Block |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 16 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 7 Participants | 3 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 12 participants | 23 participants | 11 participants |
| Sex: Female, Male Female | 7 Participants | 12 Participants | 5 Participants |
| Sex: Female, Male Male | 5 Participants | 11 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 12 |
| other Total, other adverse events | 1 / 11 | 2 / 12 |
| serious Total, serious adverse events | 0 / 11 | 0 / 12 |
Outcome results
Opioid Requirements Assessed at 24 Hours Post-surgery
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.
Time frame: 24 Hours post-surgery
Population: Data were not collected/aggregated and, as such, no data was available for analysis of Outcome Measure.
Intra-Operative Opioid Requirements
Opioid requirements (morphine equivalents) during surgery. Will report how much pain management medication participant needed during surgery.
Time frame: Duration of Surgery (Approximately 3 hours)
Population: Data were not collected/aggregated and, as such, no data was available for analysis of Outcome Measure.
Opioid Requirements Assessed at 48 Hours Post-surgery
48 hour Opioid requirements (morphine equivalents). Will report how much pain management medication participant needed within first 48 hours after surgery.
Time frame: 48 hours post-surgery
Population: Data were not collected/aggregated and, as such, no data was available for analysis of Outcome Measure.
Opioid Requirements Assessed at 8-hours Post-surgery
8-hour Opioid requirements (morphine equivalents). Will report how much pain management medication participant needed within first 8 hours after surgery.
Time frame: 8 hour post-surgery
Population: Data were not collected/aggregated and, as such, no data was available for analysis of Outcome Measure.
Pain Score in Post Anesthesia Care Unit (PACU)
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)
Time frame: During time in PACU (up to 5 hours)
Population: Data were not collected/aggregated and, as such, no data was available for analysis of Outcome Measure.
Length of Stay
Number of days subjects stayed until discharge. Will report how many days participant stayed in hospital after surgery.
Time frame: At Discharge (up to 3 days)
Population: Data were not collected/aggregated and, as such, no data was available for analysis of Outcome Measure.