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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

Tracking Information
First Submitted Date  ICMJE June 15, 2021
First Posted Date  ICMJE June 21, 2021
Last Update Posted Date January 14, 2022
Actual Study Start Date  ICMJE December 15, 2021
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 15, 2021)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2021)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine Infusion for Neuropathic Pain in Brachial Plexus Injuries
Official Title  ICMJE Ketamine Infusion for Treatment of Chronic Neuropathic Pain in Traumatic Brachial Plexus Injuries, a Prospective Randomized Control Study
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Brachial Plexus Injury
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: Ketamine Infusion Group
    Subjects will receive ketamine infusion during their planned surgery and postoperatively.
    Intervention: Drug: Ketamine Infustion
  • No Intervention: Standard of Care Group
    Subjects will receive general anesthesia as standard of care during their planned surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: June 15, 2021)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2024
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04933149
Other Study ID Numbers  ICMJE 20-011213
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Alexander Y. Shin, M.D., Mayo Clinic
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Mayo Clinic
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alexander Shin, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date December 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP