Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04764916 |
| Other study ID # |
19-574 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
February 16, 2021 |
| Est. completion date |
March 2, 2022 |
Study information
| Verified date |
February 2021 |
| Source |
Carilion Clinic |
| Contact |
Thomas K Miller, MD |
| Phone |
540-512-1082 |
| Email |
TKMiller[@]carilionclinic.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This is a prospective, randomized study for adult patients presenting to the Carilion Clinic
Institute of Orthopedics and Neurosurgery. Patients undergoing isolated ACL reconstruction
will be eligible for inclusion. All patients will receive an adductor canal block (either
with bupivacaine or Exparel. Patients will be given a pain diary for self-report of pill
counts, pain scores, block duration, and pain control satisfaction). Pill counts and pain
scores will also be taken by a team member at two and six-week post-operative visits. Primary
outcomes include opioid requirements and pain scores.
Description:
Patients who have an isolated anterior cruciate ligament reconstruction scheduled to be
performed at Roanoke Ambulatory Surgery Center (RASC) by one of the participating Carilion
surgeons will be prescreened, assessed for eligibility and consented at the pre-operative
visit.
This office visit already includes: a formatted discussion regarding the risks, benefits and
alternatives to surgery; and a review of the opioid policy and patient agreement used by
Carilion Clinic's Institute for Orthopaedics and Neurosciences (ION). The PI or
sub-investigators will conduct the discussion regarding the rationale and use of adductor
canal block (ACB) with the procedure, the rationale for assessment of alternate medications
used for the study, and any other pertinent details. An approved research team member will
review all sections of the IRB approved research consent in detail, in person at the pre-
operative visit. All questions will be answered, and physical signatures will be obtained.
Both research groups, control and experimental, will sign the same consent document. A copy
of the signed consent will be provided to the participant.
All participants will be given a pain diary to take home and begin filling out on post-op day
#1 (POD#1). Per patient preference, pain diary may be physical copy or done electronically
via REDCap.
All participants will be instructed on how to record entries in the pain diary by an approved
research team member, and will be instructed to record entries daily. The pain diary will
have templated pages with areas to record the amounts and names of medications they consumed,
Numeric Rating Scale (NRS) score, Intervention Based Pain Scale (IBPS) score, as well as
satisfaction levels and a place to record how long their anesthetic block lasted. NRS
responses will be indicated by circling a number ranging from 0 (no pain) to 10 (worst pain
imaginable). IBPS responses will be indicated by asking patients to check a box next to the
statement that best describes their pain management that day. A numerical score will be
associated with responses ranging from 1-6. Patient satisfaction will be asked regarding
their pain management for the day on a 5-point likert scale ranging from very dissatisfied to
very satisfied. Field block duration will be recorded in hours.
All participants will be provided the same information and education regarding postoperative
pain management protocol and expectations.
This is standard of care at Carilion Clinic's ION and includes:
A review of the opioid policy and patient agreement used by Carilion Clinic's ION as well as
a discussion about proper use of the pain medication to be prescribed for postoperative pain
management A discussion regarding the pain blocks used with the procedure and their likely
duration of analgesia A discussion of scheduled postoperative visits and how to contact the
office with questions/concerns regarding recovery
The random number generator feature in REDcap will be used to randomly assign subjects to
receive the standard Bupivacaine HCl ACB or the Exparel ACB. Surgery schedules at RASC are
released on Friday the week before. We will retrieve the surgery schedule on Fridays from
RASC, find our 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, we 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 in order to gather and administer the proper medications.
Charge nurses will see the designation of group A or B in the envelope attached to the
subject's chart and gather the appropriate anesthetic medications for the anesthesiologists.
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. Patients may opt to be unblinded to their group assignment at
their 6- week post- operative visit.
All patients will be undergoing a routine ACLR. The procedure will not deviate from the
standard of care operation that is typically performed. All patients will receive
post-operative pain medication regimens established by the participating physicians. This
regimen is as follows: Loading dose of Toradol in OR (15- 30mg dependent on patient risk
factors) followed by prescription for 20 tabs oral Hydrocodone /Acetaminophen (Norco) 5/325
mg and 15 tabs oral Toradol 10mg. Intraoperative supplemental anesthesia will include
Marcaine 0.5% or 1% with epinephrine (dependent on medication availability). Additional NSAID
use and DVT prophylaxis will be left to discretion of patient and provider.
Prior to their operation, all patients will receive an ultrasound-guided ACB 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 ACB and the experimental group will receive an
Exparel ACB.
On the day of surgery all patients 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 patients
and will mark the side and location of the procedure. The anesthesiologist will review the
ACB procedure with the patient and ensure correct side and location marked by physician.
Before the anesthesiologist begins administration of the ACB, a surgical time-out is
performed with the operating surgeon, the anesthesiologist and the patient. This is a
universal procedure and is the final reassurance of accurate patient identity, surgical site,
and planned procedure. In addition, the correct patient positioning, presence of allergies,
and the availability of relevant documents and diagnostic tests, instruments, implants and
other pertinent equipment are confirmed during this time. A second time-out will also be
performed prior to the start of the operation.
In the pre-operative holding area, the anesthesiologist will administer the ACB under
ultrasound guidance. Patients in the control group will receive 20mL of standard 0.5%
bupivacaine. Patients in the intervention group will receive 10mL of standard 0.5%
bupivacaine, followed by 10mL of Exparel. If patients are unable to sit still during ACB
administration, they may be sedated by the anesthesiologist with one of the following
(Medications and dosages vary based on patient need. Most common medications used listed
below):
Versed Fentanyl Propofol
15-20 minutes after administration of ACB's (Bupivacaine HCl or Exparel), all patients will
undergo induction of anesthesia by the anesthesiologist. After general anesthesia takes
effect, all patients will be operated on by their orthopaedic surgeon.
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 post-operatively that
will assess 5 measures:
Medication consumption (dose & number of pills) - will be asked to record daily Pain score on
the NRS - will be asked to record daily Pain score on an institutional IBPS - will be asked
to record daily Patient satisfaction - will be asked to record daily Block duration - will be
reminded to record if their block has worn off, and if so, how many hours it was effective
(until they regained sensation).
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 calls will be made by trained, authorized site delegates. There will be a locked drop-box
in the ION building where patients can drop off their pain diaries after their 2-week follow-
up appointment if they forget to bring it in to their appointment.
All participants will come into the office for a follow-up appointment at 2-weeks and all
particpants will have either a telehealth or in-person appointment at 6 weeks. 2-week
appointments will be in-person, as they will need to come in for suture removal.
At the first follow up appointment (week 2), all participants will be expected to bring in
their opioid medication pill bottles and their pain diaries per instructions given at study
enrollment and on the reminder phone call. All participants will be shown where the lock
boxes are to deposit their pain diaries. Pill counts will be conducted and recorded as well
as number of refills.
At the second follow up appointment (week 6), all participants will be expected to bring in
their opioid medication pill bottles (if in person) per instructions given at study
enrollment and on the reminder phone call.
Pill counts will be conducted and recorded as well as number of refills. If 6-week visit is
done via telehealth, the same procedures will apply accordingly.
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.
