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About
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.
Full description
Patients who have an Arthroscopic Rotator Cuff Repair (ARCR) scheduled to be performed at Roanoke Ambulatory Surgery Center (RASC) by one of the participating surgeons will be prescreened, assessed for eligibility and consented at the pre-operative visit.
All participants will be given a pain diary to take home and begin filling out the day following their surgery. Per participant preference, pain diary may be physical copy or done electronically via REDCap.
Participants in both study groups will be provided the same information and education regarding postoperative pain management protocol and expectations. This includes:
The investigators will use the random number generator feature in REDcap to randomly assign subjects to receive the standard Bupivacaine HCl ISB or the Exparel ISB. Surgery schedules at RASC are released on Friday the week before. The investigators will retrieve the surgery schedule on Fridays from RASC, find study subjects, and randomize them to group A (Exparel) or group B (Bupivacaine HCl) that same day (the Friday before surgery). Once the subjects are randomized, the investigators will communicate the randomization to a RASC staff member and they will put the arm designation (group A or group B) in an envelope and attach it to the subject's chart for the day of surgery. The contents of the envelope will only be seen by Anesthesia providers and charge nurses prior to the surgery with no other study staff in the room (so the blind is not broken). Charge nurses and anesthesiologists at RASC will be unblinded to the definitions of groups A & B to gather and administer the proper medications. Surgeons will not be in the room at the time of anesthetic administration. The patient and all other providers including physicians and physician assistants will be blinded to the result of the randomization. Participants may opt to be unblinded to their group assignment at their 6-week post operative visit.
All participants will be undergoing a routine ARCR. The procedure will not deviate from the standard of care operation that is typically performed. All participants will receive an ultrasound-guided ISB by a pool of anesthesia providers at RASC. The only difference between subject groups is that the control group will receive a standard Bupivacaine HCl ISB and the experimental group will receive an Exparel ISB.
On the day of surgery all participants will be brought to the pre-operative holding area at RASC where they are seen prior to the surgical procedure by both the operating surgeon and the anesthesiologist. The operating surgeon will review the surgical procedure with all participants and will mark the side and location of the procedure. The anesthesiologist will review the ISB procedure with the participant and ensure correct side and location marked by physician. Before the anesthesiologist begins administration of the ISB, an anesthesia time-out is performed with the anesthesiologist and the participant to confirm patient identity, surgical site, and planned procedure.
In the pre-operative holding area or the operating room, the anesthesiologist will position all participants in the recumbent position with a slight roll onto the opposite side from the block and will administer a local infiltration of the skin with 1-2mL of Bupivacaine HCl 0.5% (dosages may vary based on participant size and pain threshold). If participants are unable to sit still during ISB administration, they may be sedated by the anesthesiologist with one of the following (Medications and dosages vary based on need):
Administration of the standard Bupivacaine HCl ISB for the control arm goes as follows:
Administration of the Exparel ISB for the experimental arm goes as follows:
15-20 minutes after administration of ISBs (Bupivacaine HCl or Exparel), all participants will be put under general anesthesia (if not already) by the anesthesiologist with one of the following (Medications and dosages vary based on patient need. Most common medications used listed below):
After general anesthetic takes effect, all participants will be operated on by their fellowship-trained orthopaedic surgeon.
All participants will be discharged with post-operative pain medications regimens based on department protocol and physician preference.
All participants will be called or seen in the office within 72 hours after surgery to assess pain status, ensure adequate pain management and will be reminded to complete the pain diary.
All participants will fill out a pain diary during the first 2 weeks postoperatively that will assess 5 measures.
All participants will be called before their 2- and 6-week follow-up appointments and will be asked to bring in their pain diaries as well as their opioid medication pill bottles to their visit so that pill counts may be conducted.
All participants will come into the office for 2 follow up appointments, at 2 and 6 weeks postoperatively.
All participant follow-up appointments will be conducted at Carilion's Institute for Orthopaedics and Neurosciences (ION) or via telemedicine, and should not take significantly longer than normal follow up appointments. Slightly increased visit duration related to conducting pill counts should not exceed about 5 minutes. All participants will be enrolled in the study for 6 weeks after their surgical date, at which point their involvement in the study will conclude.
Enrollment
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Inclusion criteria
Exclusion criteria
American Society of Anesthesiologists (ASA) status IIIb or greater.
ASA status III is characterized by:
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.
Examples of individuals that would classify as ASA IIIa include:
Examples of individuals that would classify as ASA IIIb include:
Currently pregnant
Documented opioid use within 30 days prior to surgery
Revision ARCR surgery
Currently taking opioid medication for chronic pain management
History of documented substance abuse or related disorders
Currently enrolled or planning to enroll in another clinical trial during this study that would affect the outcome of this study
Allergic reactions to amide anesthetics
Neurologic deficit or disability involving the surgical extremity
Unwilling or unable to consent
History of cognitive or mental health status that would interfere with study participation
Primary purpose
Allocation
Interventional model
Masking
17 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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