Ketamine Infusion for Neuropathic Pain in Brachial Plexus Injuries

Last updated: March 28, 2025
Sponsor: Mayo Clinic
Overall Status: Active - Enrolling

Phase

4

Condition

Nerve Injury

Pain

Pain (Pediatric)

Treatment

Ketamine Infustion

Clinical Study ID

NCT04933149
20-011213
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with neuropathic pain associated with avulsion injuries following traumaticbrachial plexus injuries scheduled for brachial plexus exploration andreconstruction by three senior surgeons at Mayo Clinic (AYS, ATB, RJS):

  • Neuropathic pain defined as pain directly related to injury to the somatosensorysystem, and score >4/10 on the Douleur Neuropathique en 4 Questions (DN4)neuropathic pain questionnaire. Symptoms of neuropathic pain include allodynia,hyperalgesia, burning, needle-like, throbbing, shooting, or electrical-typesensation.

  • Nerve root avulsion on CT myelogram.

  • Traumatic brachial plexus injuries defined as blunt or penetrating trauma resultingin injury and dysfunction along the course of the brachial plexus defined as nerveroots C5-T1, trunks, divisions, cords, and terminal branches.

Exclusion

Exclusion Criteria:

  • Patients without pain following traumatic brachial plexus injuries.

  • Patients with brachial plexus injuries due to non-traumatic causes such as tumors,infection, radiation, or inflammatory disorders such as Parsonage Turner Syndrome.

  • Patients who do not require surgery for exploration/reconstruction at the brachialplexus.

  • Patients under 18 years of age.

  • Contraindication to ketamine use (severe hepatic dysfunction -cirrhosis, high-riskcoronary artery disease, poorly controlled psychiatric condition- schizophrenia.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Ketamine Infustion
Phase: 4
Study Start date:
December 15, 2021
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Mayo Clinic in Rochester

    Rochester, Minnesota 55905
    United States

    Site Not Available

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