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Influence of Anesthetic Technique on Acute and Chronic Neuropathic Pain

Primary Purpose

Acute Pain, Chronic Pain, Hernia

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Propofol
Sevoflurane
Remifentanil
Ketamine
Sponsored by
VA Pittsburgh Healthcare System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    BIA

    TIVA-K

    TIVA-R

    Arm Description

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

    Total intravenous anesthetic with ketamine

    Total intravenous anesthetic with remifentanil

    Outcomes

    Primary Outcome Measures

    Change in Chronic Pain, as measured by the Pain Quality Assessment Scale

    Secondary Outcome Measures

    Change in Acute Pain, as measured by the Verbal Response Scale (0-10)

    Full Information

    First Posted
    January 27, 2015
    Last Updated
    October 6, 2020
    Sponsor
    VA Pittsburgh Healthcare System
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02527083
    Brief Title
    Influence of Anesthetic Technique on Acute and Chronic Neuropathic Pain
    Official Title
    Influence of Anesthetic Technique on Acute and Chronic Neuropathic Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    June 2019 (Actual)
    Study Completion Date
    June 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    VA Pittsburgh Healthcare System

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Pain, Chronic Pain, Hernia, Anesthesia, Intravenous, Anesthesia, Intratracheal

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    BIA
    Arm Type
    Active Comparator
    Arm Description
    Balanced Inhalational Anesthesia (consisting of a sevoflurane inhaled anesthestic only)
    Arm Title
    TIVA-K
    Arm Type
    Active Comparator
    Arm Description
    Total intravenous anesthetic with ketamine
    Arm Title
    TIVA-R
    Arm Type
    Active Comparator
    Arm Description
    Total intravenous anesthetic with remifentanil
    Intervention Type
    Drug
    Intervention Name(s)
    Propofol
    Intervention Type
    Drug
    Intervention Name(s)
    Sevoflurane
    Intervention Type
    Drug
    Intervention Name(s)
    Remifentanil
    Intervention Type
    Drug
    Intervention Name(s)
    Ketamine
    Primary Outcome Measure Information:
    Title
    Change in Chronic Pain, as measured by the Pain Quality Assessment Scale
    Time Frame
    1 month, 3 months, 6 months, 12 months
    Secondary Outcome Measure Information:
    Title
    Change in Acute Pain, as measured by the Verbal Response Scale (0-10)
    Time Frame
    Within 30 minutes after arrival to Post-Operative Care Unit (recovery unit), 1 day

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

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