Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT04833777 |
Other study ID # |
Bio2640 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 1, 2021 |
Est. completion date |
April 1, 2023 |
Study information
Verified date |
July 2021 |
Source |
University of Saskatchewan |
Contact |
David Sauder, MD |
Phone |
306-955-9800 |
Email |
Djs126[@]mail.usask.ca |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This study is being conducted to determine whether addition of a longer-acting local
anesthetic to our current anesthetic protocol improves the post-operative pain after carpal
tunnel release. Participants undergoing carpal tunnel release (CTR) will be randomly assigned
to one of two groups: the standard anesthetic or the longer-acting anesthetic. Participants
will not be aware of their assignment. Carpal tunnel release will be performed in the
standard fashion at our hospital. Participants will record their post-operative pain on a
visual scale at 2, 4, 6, 8, and 10 hours after surgery. They will also record the location of
their post-operative numbness at the same time intervals. The day after surgery, a research
nurse will call each participant to inquire about their post-operative pain scores and
numbness. Participants will also be asked about their consumption of oral painkillers (e.g.
Tylenol, ibuprofen) during the first 24 hours. Participants will be re-assessed 3 months
after surgery to evaluate improvement in carpal tunnel symptoms.
Participants who wish to have carpal tunnel release on both wrists will be randomized to
receive one type of anesthetic for the first side and will receive the other anesthetic for
the second side. They will not be made aware of which medication is used for each side. This
will allow us to directly compare the difference in pain experience between the two
anesthetics.
We hypothesize that use of a longer-acting local anesthetic will lead to decreased
post-operative pain, especially in the first 4-8 hours after surgery.
Description:
A research nurse will meet with each patient presenting for outpatient CTR surgery at the
Saskatoon City Hospital procedure room. He or she will obtain informed consent for interested
participants. The patient will be assigned a subject number and be randomized to standard vs.
bupivacaine treatment based on a computer algorithm. Participants will complete the Boston
Carpal Tunnel Questionnaire as a baseline for comparison as well as a brief questionnaire on
demographics. For those patients that are having both sides released during the study period,
the first side will be randomized based on the study protocol and the second side will be
anesthetized with the other treatment. They will be blinded to both procedures such that we
can directly compare their operative experience.
The surgeon will draw up and mix the pre-determined local anesthetic (LA) for each patient
based on the randomization protocol. The research nurse (who will be performing all
assessments) and the patient will remain blinded to the type of anesthetic.
The two types of anesthetic will be:
1. 10 mL 1% lidocaine with 1:100,000 epinephrine and 1 mL 8.4% sodium bicarbonate (standard
treatment)
2. 5 mL 1% lidocaine with 1:100,000 epinephrine + 5 mL 0.5% bupivacaine with 1:100,000
epinephrine and 1 mL 8.4% sodium bicarbonate (bupivacaine treatment)
The participants will be anesthetized in the standard fashion, with all 11 mL of LA
infiltrated subcutaneously into the area of the incision. After a delay of 20-40 minutes, the
CTR will be carried out using the standard mini-open approach. Patients will be provided with
the standard post-operative instructions regarding activity and wound care.
After the procedure, participants will complete a short questionnaire (VAS) about any pain
experienced during the administration of the local anesthetic and during the procedure.
Patients will be sent home with instructions to complete a pain and numbness assessment at 2,
4, 6, 8, and 10 hours after surgery. They will be provided with a form containing the VAS and
the times at which they are to self-administer this pain scoring system. Additionally, they
will be provided with 20 Tylenol tablets (325mg each) and 20 ibuprofen tablets (200mg each),
with instructions to take 1-2 tablets of one or both analgesics every 6 hours as needed
during the first 24 hours. They will be asked to document the times at which they took the
medications, as well as the dosages taken. They will be asked to refrain from using other
types of pain medications, if possible. They will also be asked to document use of any other
analgesics including Cannabis. Any questions will be answered by the research nurse before
leaving clinic.
The day after surgery, at the 24 hour mark, the research nurse will call each patient and
inquire about their pain scores and numbness at 2, 4, 6, 8, and 10 hours, as well as the
present time (24 hours). He or she will also ask about the number of Tylenol and/or ibuprofen
pills taken during the first 24 hours, as well as the timing of consumption. This information
recorded on a password-protected datasheet which contains only the subject number (no
identifiers).
The patient will return for their standard follow-ups. At 3 months, the research nurse will
repeat the Boston Carpal Tunnel Questionnaire to assess outcome. At this time, if the patient
wishes, they may be unblinded.
For patients wishing for bilateral CTR, the first will be performed according to the
randomization protocol as described above. The contralateral CTR will be performed 2-8 weeks
later (as standard in our practice), with the alternate anesthetic (e.g. first CTR with
standard treatment, second CTR with bupivacaine treatment). The same post-operative
assessment will be performed for the second CTR. Patients will remain blinded to their type
of anesthetic in each wrist until 3 months after the second surgery is performed. At that
time, they will be asked by the research nurse whether the first or second surgery provided a
better pain experience. Only after this will they be unblinded, if desired.