We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ketamine Infusion for Neuropathic Pain in Brachial Plexus Injuries

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04933149
Recruitment Status : Enrolling by invitation
First Posted : June 21, 2021
Last Update Posted : January 14, 2022
Sponsor:
Information provided by (Responsible Party):
Alexander Y. Shin, M.D., Mayo Clinic

Brief 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.

Condition or disease Intervention/treatment Phase
Brachial Plexus Injury Drug: Ketamine Infustion Phase 4

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. Adverse Events [ Time Frame: 6 weeks ]
    Number of participants to experience sepsis, embolism, wound healing failure, hematomas, or nightmares/hallucinations following surgery



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with neuropathic pain associated with avulsion injuries following traumatic brachial plexus injuries scheduled for brachial plexus exploration and reconstruction by three senior surgeons at Mayo Clinic (AYS, ATB, RJS):
  • Neuropathic pain defined as pain directly related to injury to the somatosensory system, 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-type sensation.
  • Nerve root avulsion on CT myelogram.
  • Traumatic brachial plexus injuries defined as blunt or penetrating trauma resulting in injury and dysfunction along the course of the brachial plexus defined as nerve roots C5-T1, trunks, divisions, cords, and terminal branches.

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 brachial plexus.
  • Patients under 18 years of age.
  • Contraindication to ketamine use (severe hepatic dysfunction -cirrhosis, high-risk coronary artery disease, poorly controlled psychiatric condition- schizophrenia.

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Layout table for investigator information
Principal Investigator: Alexander Shin, MD Mayo Clinic
Additional Information:
Layout table for additonal information
Responsible Party: Alexander Y. Shin, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04933149    
Other Study ID Numbers: 20-011213
First Posted: June 21, 2021    Key Record Dates
Last Update Posted: January 14, 2022
Last Verified: December 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neuralgia
Wounds and Injuries
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action