Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
NCT number |
NCT04933149 |
Other study ID # |
20-011213 |
Secondary ID |
|
Status |
Enrolling by invitation |
Phase |
Phase 4
|
First received |
|
Last updated |
|
Start date |
December 15, 2021 |
Est. completion date |
June 2025 |
Study information
Verified date |
April 2024 |
Source |
Mayo Clinic |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to assess pre- and postoperative neuropathic pain in patients
with traumatic brachial plexus injuries to determine if intraoperative ketamine infusion
affect neuropathic pain associated with avulsion injuries of the brachial plexus.
Description:
Neuropathic pain following traumatic brachial plexus injuries is a common and debilitating
problem that has been reported in up to 64-75% of patients. Neuropathic pain is difficult to
treat, particularly when secondary to avulsion injuries of the brachial plexus. Current
treatment options include neuromodulating pharmacologic agents including gabapentin,
pregabalin, tricyclic antidepressants, and duloxetine among others. Other analgesic
modalities include TENS unit application, massage, acupuncture, and topical medications.
Despite these treatment options, patients frequently continue to experience significant,
debilitating neuropathic pain.
The use of ketamine has recently been studied in complex regional pain syndrome (CRPS),
spinal cord injuries, and chronic neuropathic pain with encouraging results. Ketamine is
thought to exert its analgesic properties via noncompetitive central nervous system
N-methyl-D-aspartate (NMDA) antagonism among other primarily central mechanisms including
sodium channel blockade, activation of D2 dopamine receptors and facilitation of
γ-aminobutyric acid A (GABA-A) signaling. It is utilized clinically in acute and chronic pain
management primarily in hospitalized settings to treat a variety of pain states as well as
medically refractory depression and headache disorders. The dosing and administration of
ketamine infusion varies widely across studies and includes oral ketamine, low dose
infusions, and infusions producing an anesthetic effect. To our knowledge, ketamine's use in
subanesthetic doses has not been adequately evaluated in patients with neuropathic pain
following traumatic brachial plexus injuries. Our study aims to determine how intraoperative
ketamine infusion alters neuropathic pain severity associated with brachial plexus avulsion
injury in the post-operative period. In addition, we hypothesize that patients receiving
intraoperative ketamine infusion will require less narcotic pain medication through the
follow-up period of 6 months following surgery.
Patients who are undergoing planned surgery for brachial plexus reconstruction at Mayo Clinic
will be enrolled into this study to be randomized into getting ketamine infusions or a
placebo medication during surgery and in the 24 hour postoperative period after surgery. Pain
will be measured before surgery and at various time points to up to 6 months after surgery
through online pain measurement scores.