Ketamine Infusion for Neuropathic Pain in Brachial Plexus Injuries
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|ClinicalTrials.gov Identifier: NCT04933149|
Recruitment Status : Enrolling by invitation
First Posted : June 21, 2021
Last Update Posted : January 14, 2022
|Condition or disease||Intervention/treatment||Phase|
|Brachial Plexus Injury||Drug: Ketamine Infustion||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Ketamine Infusion for Treatment of Chronic Neuropathic Pain in Traumatic Brachial Plexus Injuries, a Prospective Randomized Control Study|
|Actual Study Start Date :||December 15, 2021|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||June 2024|
Experimental: Ketamine Infusion Group
Subjects will receive ketamine infusion during their planned surgery and postoperatively.
Drug: Ketamine Infustion
Intravenous infusion at 0.5 mg/kg/hr from induction to emergence from anesthesia during the subject's brachial plexus reconstruction surgery. In addition, subjects will receive postoperative ketamine infusion of 0.1-0.3 mg/kg/hr for 24 hours titrated to side effects while patients are admitted to the hospital following surgery.
Other Name: Ketamine
No Intervention: Standard of Care Group
Subjects will receive general anesthesia as standard of care during their planned surgery
- Change in PROMIS Pain Quality - Neuropathic Pain (PQ-Neuro) score [ Time Frame: Baseline, 1 week ]Measured by the PROMIS Pain Quality - Neuropathic Pain (PQ-Neuro) self-reported questionnaire asking about pain in the past 7 days using a scale of 1=not at all and 5=very much. Higher scores indicate a worse outcome.
- Opioid medication use [ Time Frame: Baseline, 1 week postoperatively ]Change in opioid medication use measured by oral morphine equivalents (OMEs) at postoperative week 1 from baseline
- Pain Score [ Time Frame: 1 day postoperatively ]Measured using the Visual Analogue Scale for pain rated from 0-10, where 0 is no pain and 10 is the worst pain imaginable.
- Adverse Events [ Time Frame: 6 weeks ]Number of participants to experience sepsis, embolism, wound healing failure, hematomas, or nightmares/hallucinations following surgery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04933149
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Alexander Shin, MD||Mayo Clinic|