Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05482113 |
| Other study ID # |
19-530 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
March 9, 2021 |
| Est. completion date |
December 15, 2021 |
Study information
| Verified date |
July 2022 |
| Source |
Carilion Clinic |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
1. 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.
- This office visit already includes: a formatted discussion regarding the risks,
benefits and alternatives to surgery; fitting for a sling; 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 rational and
use of Interscalene Brachial Plexus Block (ISB) 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.
2. 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.
- All participants will be instructed on how to record entries in the pain diary by an
approved research team member. The pain diary will have templated pages with areas to
record the amounts and names of medications they consumed, their Numerical Rating Scale
(NRS) score, their Intervention Based Pain Scale (IBPS) score, as well as satisfaction
levels and a place to record how long their anesthetic block lasted.
3. Participants in both study groups will be provided the same information and education
regarding postoperative pain management protocol and expectations. This 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 ISBs 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
4. 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.
5. 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.
6. 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.
7. 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):
- Versed
- Fentanyl
- Propofol
8. Administration of the standard Bupivacaine HCl ISB for the control arm goes as follows:
- After proper positioning and local infiltration, a linear high-frequency ultrasound
transducer will be placed on the anteromedial aspect of the neck, approximately 2 cm
above the clavicle, and the interscalene brachial plexus will be identified between the
anterior and middle scalene muscles. After sterile preparation of the skin, a 22-gauge
block needle will be inserted in-plane from the lateral aspect of the transducer and
directed through the middle scalene muscle. The needle will be advanced until the tip is
observed just lateral to the brachial plexus sheath. After negative aspiration, 20mL of
0.5% bupivacaine will be injected in 5mL increments, followed by 20mL of 0.25%
bupivacaine injected in 5mL increments. The injection will be administered slowly with
periodic aspiration, with the needle being adjusted using ultrasound guidance as the ISB
is injected to surround the brachial plexus trunks (upper, middle and lower) that are
seen at the interscalene level of injection. There will be only one injection site.
9. Administration of the Exparel ISB for the experimental arm goes as follows:
- After proper positioning and local infiltration, a linear high-frequency ultrasound
transducer will be placed on the anteromedial aspect of the neck, approximately 2 cm
above the clavicle, and the interscalene brachial plexus will be identified between the
anterior and middle scalene muscles. After sterile preparation of the skin, a 22-gauge
block needle will be inserted in-plane from the lateral aspect of the transducer and
directed through the middle scalene muscle. The needle will be advanced until the tip is
observed just lateral to the brachial plexus sheath. After negative aspiration, 20mL of
0.5% bupivacaine will be injected in 5mL increments, followed by 20mL of Exparel
injected in 5mL increments. The injection will be administered slowly with periodic
aspiration, with the needle being adjusted using ultrasound guidance as the ISB is
injected to surround the brachial plexus trunks (upper, middle and lower) that are seen
at the interscalene level of injection. There will be only one injection site.
10. 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):
- Versed
- Fentanyl
- Propofol
11. After general anesthetic takes effect, all participants will be operated on by their
fellowship-trained orthopaedic surgeon.
- During the operation, all participants may receive an intravenous injection of Toradol
(15-30 mg based on weight and renal function)
12. All participants will be discharged with post-operative pain medications regimens based
on department protocol and physician preference.
- Oral Opioid Medication: 5mg/325mg hydrocodone/acetaminophen q4-6h prn pain
- Non-Opioid Pain Medication: 10mg Toradol q8h prn pain 5 days maximum
13. 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.
14. All participants will fill out a pain diary during the first 2 weeks postoperatively
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
- Nerve 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).
15. 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 participants can drop off their pain diaries after
their 2-week follow-up appointment if they forget to bring it in to their appointment.
16. All participants will come into the office for 2 follow up appointments, at 2 and 6
weeks postoperatively.
- At the 2-week postoperative visit, all participants will be expected to bring in
their opioid medication pill bottles and 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 pain diaries. Pill counts will be conducted and
recorded as well as number of refills.
- At the 6-week postoperative visit, all participants will be expected to bring in
the opioid medication pill bottles 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.
17. 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.
