Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT04861441 |
| Other study ID # |
STUDY20100056 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 22, 2021 |
| Est. completion date |
June 24, 2022 |
Study information
| Verified date |
June 2023 |
| Source |
University of Pittsburgh |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This is a randomized prospective study to test if cooling therapies decrease narcotic pain
medication use in patients following total shoulder replacement surgery (total shoulder
arthroplasty, TSA). Postoperative standard care involves use of ice packs placed on the
surgical site for periods of approximately 20 minutes every 2 hours, but they do not provide
consistent temperature and can become uncomfortably cold. Continuous cryotherapy (CC)
machines provide flow of continuous cooled water (45-55° F) via a cuff placed on the affected
sight for several hours. There are mixed results as to whether CC is more beneficial than
standard ice pack therapy. This study will address whether CC decreases pain and narcotic
pain medication use compared to ice pack therapy in TSA patients. The investigators will
monitor both patient-reported pain scores and actual narcotic use to test the hypothesis that
use of CC reduces postoperative pain and the need for narcotic pain medication. The results
of this study may help establish parameters for non-pharmacologic intervention to reduce
patient reliance on narcotic medications.
Description:
Prior to the surgical procedure, the patients will be met by one of the coinvestigators or
Dr. Williams in the preoperative holding area. At this time, the patients will be
administered a questionnaire about their current pain level using a Visual Analog Scale (VAS)
of 0-10, where 0 is no pain and 10 is the worse pain imaginable. The questionnaire will be
the same questionnaire used after surgery, so questions referencing ice use will be
disregarded for this initial interview. After all questions have been answered, patients will
receive an interscalene block by the anesthesiology team prior to being brought to the
operative suit. Interscalene block routinely performed prior to shoulder arthroplasty at our
institution.
At the conclusion of the surgery, a randomly assigned envelope indicating the arm of the
study will be opened. At that time, the indicated therapy (ice pack or CC) will be initiated.
Ice packs and CC machines will be available and readily accessible for nursing staff to
assist study participants. The CC group will use the following protocol:
The CC will be initiated immediately after surgery, with application of the CC cuff in the
OR. Temperature will be set to between 45-55°F. The machine will be worn continuously for the
first 72 hours postoperatively. The machine is portable and can be taken with the patients as
they move about the hospital/home. After the first 72 hours CC will be used as needed.
Patients will be encouraged to use the CC whenever their pain is rated 4-5 on the VAS. Prior
to discharge, the patient will be instructed on machine use and the at home protocol. The
protocol includes when to wear the machine and how to record CC and narcotic use. Written
instructions for the protocol and a diary for recording usage will be provided to the
patient. The patients will document the time and duration the machine is in use, along with
their pain prior to and after use. The protocol will continue through postoperative day 28.
Data collection will end a postoperative day 28, though patients may continue to use the
machine longer if they choose.
The standard ice therapy group will use the following protocol:
The standard ice therapy will be initiated immediately post-operatively. While in the
hospital, ice will be applied for 20 minutes every 2 hours. Upon discharge, ice pack therapy
will be applied for 20 minutes every 2 hours while awake. (Patient do not need to wake up
every 2 hours to apply ice at night.) After 72 hours post-operative, patient may apply ice
therapy for 20 minutes as needed, in 2 hour time increments. Patients will be encouraged to
use the ice whenever their pain is rated 4-5 on the VAS. Prior to discharge, the patient will
be instructed about ice pack use and the at home protocol. The protocol includes when to use
ice and how to record ice usage and narcotic use. Written instructions for the protocol along
with a diary will be provided to the patient. Subjects will document the time and duration
the standard ice therapy is in use along with their pain prior to and after usage. This will
be continued until postoperative day 28, when data will stop being collected. The patient may
continue to use icepacks after postoperative day 28 if they choose.
The postoperative pain regimen will begin in the hospital. Both groups will have scheduled
Tylenol, 650 mg every 6 hours. Patients will also receive 3 doses of 15 mg of Toradol
starting on postoperative day 1. They will also have oxycodone available, with 5 mg for VAS
of 1-3, 10 mg for VAS of 4-6, and 15 mg for VAS of 7-10. If patients do not tolerate
oxycodone, or require additional narcotics for pain, these will be adjusted. This adjustment
will be offset by using a conversion to morphine equivalents for data analysis purposes.
Throughout the hospital stay, narcotic use will be recorded in terms of morphine equivalents
by using the Medication Administration Record (MAR) tab within PowerChart.
Subjective VAS pain scores will be obtained by nursing every 4 to 8 hours as this is required
for the administration of oxycodone per protocol. Along with having nursing obtain the pain
score, one of the co-investigators will conduct postoperative interviews with patients at 24
and 48 hours using the same questionnaire that was used preoperatively with ice use questions
included. The same questions will be asked to both groups. As most patients discharge on
postoperative day 2, the investigators will defer further interview until postoperative day
7.
Upon discharge, patients will be provided the following pain regimen protocol: Tylenol 650 mg
every 6 hours for VAS 1-3, Tylenol 650 mg plus 600 mg Ibuprofen every 6 hours for VAS 4-6,
and Tylenol 650 mg plus 5 mg Oxycodone every 6 hours. Prior to the patient taking medication,
they will asked to record the following information on provided diary: current VAS score,
pain medication taken, and therapy usage (either cryo or ice packs).
On postoperative day 7, a phone interview will be conducted to again evaluate the patient's
pain and document narcotic use during the first postoperative week. For patient's pain score,
the investigators will ask what they felt was their average score throughout the week. For
the narcotic use the investigators will ask them how many pills they have taken while at
home. Conversion will be used to standardize all values to morphine equivalents. Ice pack or
CC machine usage will be reviewed and documented. Medication and ice use will also be
recorded on the patient diary to monitor consistency of responses.
An in-person interview using the same format as phone interviews will occur at their
postoperative visit approximately 14 days after surgery. This is the standard follow-up
appointment for patients. Patients will turn in their written logs and narcotic use will be
monitored by counting the remaining pills in the patient's prescription bottle. At this time,
another diary sheet will be provided for the patient along with a prepaid envelope to OSME.
A second phone interview will occur on postoperative day 28, when the investigators
anticipate ice have ceased. Pain scores, narcotic use, and the date(s) of cessation, if
applicable, will be recorded. At this time, patients will be instructed to mail in their
diaries using the prepaid envelope. Patient can continue using the respective therapy as
needed at this point. If patients are still taking narcotics at day 28 postoperatively, this
will be noted, and the investigators will continue to help control their pain.
