Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03380533 |
| Other study ID # |
2960 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 2/Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
September 22, 2016 |
| Est. completion date |
April 6, 2021 |
Study information
| Verified date |
April 2021 |
| Source |
Hospital Italiano de Buenos Aires |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Arthroscopic rotator cuff repair is associated with poor post-operative pain management. The
multimodal analgesic scheme (oral non-steroidal anti-inflammatory drugs associated with oral
opioids) currently used according to the pain management guidelines is insufficient for most
of these patients.
There are few reports on the use of buprenorphine in post-operative pain with encouraging
results. There is no evidence of its use in the management of post-operative pain of
arthroscopic rotator cuff repair
Description:
Traditionally, oral opioids have been used to manage the postoperative pain of arthroscopic
rotator cuff repair (ARCR) . Due to the intensity of pain, it often requires high doses of
opioids, frequently associated with side effects, such as nausea, vomiting, constipation,
disorientation, among others, which, in the context of an outpatient, interfere with the
postoperative period, sometimes resulting in hospital readmissions. due to both the poor
management of pain and the adverse effects of opioids.
Although there are invasive strategies of analgesia, such as the placement of continuous
infusion catheters of analgesics in the sub-acromial space, these are methods that demand the
management of the devices, in some cases requiring prolongation of hospitalization for the
patient. management of the same, without being exempt from complications as any analgesic
method added to those related to the method.
Currently, the post-operative analgesia strategy widely accepted globally and that used in
our center, is multimodal analgesia, in which NSAIDs (Anti-Inflammatory Non-Steroids) and
oral opioids are associated. A combination of both analgesic mechanisms of action is used as
a basic scheme, and rescues with opioids are carried out orally. Although the literature
supports its cost-benefit, this approach is often insufficient, not achieving adequate
control of postoperative pain in ARCR, with 64% of our patients reporting poor pain
management in the first week of post-operative and 10% that require re-entry to day hospital
for pain management.
The application of transdermal opioid release patches is a method of non-invasive analgesia,
which has previously been used with good results for the management of postoperative pain. In
ARCR there is no evidence of its use in the management of post-operative pain The main
advantages could be related to the plasma stability of the drug (buprenorphine), which
implies fewer peaks and valleys of analgesia, a better compliance by the patient since it is
of weekly duration and lower incidence of cognitive deterioration related to other opioids.
Compared with other opioids, buprenorphine is associated with a lower risk of abuse, overdose
and poisoning due to the ceiling effect. Despite this favorable pharmacological profile, the
use of buprenorphine in patches has a lower abuse rate than other forms of administering the
same drug. On the one hand, the release rate of the patch may be insufficient to satisfy the
compulsive desire and, to that end, the patch may be less desirable. On the other hand, the
availability in the market and the way to use the patches could be other conditioning
factors.
