Ketamine Infusion for Neuropathic Pain in Brachial Plexus Injuries

NCT04933149 | Enrolling By Invitation Phase 4 FDA Drug

• 1 other identifier: 20-011213
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Brachial Plexus Injury

Outcome Measures

Primary Outcomes (1)

• Change in PROMIS Pain Quality - Neuropathic Pain (PQ-Neuro) score

  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.

  Baseline, 1 week

Secondary Outcomes (3)

• Opioid medication use

  Baseline, 1 week postoperatively

• Pain Score

  1 day postoperatively

• Adverse Events

  6 weeks

Study Arms (2)

Ketamine Infusion Group

EXPERIMENTAL

Subjects will receive ketamine infusion during their planned surgery and postoperatively.

Drug: Ketamine Infustion

Standard of Care Group

NO INTERVENTION

Subjects will receive general anesthesia as standard of care during their planned surgery

Interventions

Ketamine Infustion DRUG

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.

Also known as: Ketamine

Ketamine Infusion Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Ketamine

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Alexander Shin, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: June 21, 2021
• Study Start: December 15, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)