Influence of Anesthetic Technique on Acute and Chronic Neuropathic Pain

Ketamine

Brief Summary

Research suggests that the type of anesthesia used for surgery may affect intraoperative stress hormone levels. There is also data to support that an increased level of stress hormones leads to increased pain after surgery. The primary aim of this study is to determine the effect of anesthesia type on long term pain after hernia surgery. In this study, patients undergoing inguinal hernia repair will be randomized to an anesthetic group, either Total Intravenous Anesthesia (TIVA) maintained with propofol or Balanced Inhaled Anesthesia (BIA) maintained with sevoflurane. This will allow us to look at any differences in short and long-term pain after hernia repair depending on type of anesthesia received.

Intervention / Treatment

  • Propofol (DRUG)
    N/A
  • Sevoflurane (DRUG)
    N/A
  • Remifentanil (DRUG)
    N/A
  • Ketamine (DRUG)
    N/A

Condition or Disease

  • Acute Pain
  • Chronic Pain
  • Hernia
  • Anesthesia, Intravenous
  • Anesthesia, Intratracheal

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years and older   (Adult, Older Adult)
    Enrollment: 10 (ACTUAL)
    Funded by: U.S. Fed
    Allocation: Randomized
    Primary Purpose: Prevention

    Masking

    SINGLE:
    • Participant

    Clinical Trial Dates

    Start date: Jan 01, 2015
    Primary Completion: Jun 01, 2019 ACTUAL
    Completion Date: Jun 01, 2019 ACTUAL
    Study First Posted: Aug 18, 2015 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Oct 06, 2020

    Sponsors / Collaborators

    Lead Sponsor: VA Pittsburgh Healthcare System
    Lead sponsor is responsible party
    Responsible Party: N/A

    Participant Groups

    • Balanced Inhalational Anesthesia (consisting of a sevoflurane inhaled anesthestic only)

    • Total intravenous anesthetic with ketamine

    • Total intravenous anesthetic with remifentanil

    Eligibility Criteria

    Sex: Male
    Minimum Age: 18
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * All male patients undergoing herniorrhaphy surgery that requires general anesthesia.

    Exclusion Criteria:

    * Subjects unable to communicate directly with the investigators, due to being non-English speaking, loss of hearing, or incompetence.
    * A history of malignant hyperthermia, pseudocholinesterase deficiency, or other disease that prevents anesthetic randomization.
    * Pain-related disorders such as fibromyalgia or other chronic pain syndromes.
    * Emergency surgery.

    Primary Outcomes
    • Change in Chronic Pain, as measured by the Pain Quality Assessment Scale 1 month, 3 months, 6 months, 12 months
    Secondary Outcomes
    • Change in Acute Pain, as measured by the Verbal Response Scale (0-10) Within 30 minutes after arrival to Post-Operative Care Unit (recovery unit), 1 day

    More Details

    NCT Number: NCT02527083
    Other IDs: PRO00000878
    Study URL: https://clinicaltrials.gov/study/NCT02527083
    Last updated: Sep 29, 2023