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Influence of Anesthetic Technique on Acute and Chronic Neuropathic Pain

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ClinicalTrials.gov Identifier: NCT02527083
Recruitment Status : Completed
First Posted : August 18, 2015
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
VA Pittsburgh Healthcare System

Tracking Information
First Submitted Date  ICMJE January 27, 2015
First Posted Date  ICMJE August 18, 2015
Last Update Posted Date October 8, 2020
Study Start Date  ICMJE January 2015
Actual Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2015)
Change in Chronic Pain, as measured by the Pain Quality Assessment Scale [ Time Frame: 1 month, 3 months, 6 months, 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2015)
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 ]
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 Influence of Anesthetic Technique on Acute and Chronic Neuropathic Pain
Official Title  ICMJE Influence of Anesthetic Technique on Acute and Chronic Neuropathic Pain
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE
  • Acute Pain
  • Chronic Pain
  • Hernia
  • Anesthesia, Intravenous
  • Anesthesia, Intratracheal
Intervention  ICMJE
  • Drug: Propofol
  • Drug: Sevoflurane
  • Drug: Remifentanil
  • Drug: Ketamine
Study Arms  ICMJE
  • Active Comparator: BIA
    Balanced Inhalational Anesthesia (consisting of a sevoflurane inhaled anesthestic only)
    Interventions:
    • Drug: Sevoflurane
    • Drug: Remifentanil
  • Active Comparator: TIVA-K
    Total intravenous anesthetic with ketamine
    Interventions:
    • Drug: Propofol
    • Drug: Ketamine
  • Active Comparator: TIVA-R
    Total intravenous anesthetic with remifentanil
    Interventions:
    • Drug: Propofol
    • Drug: Remifentanil
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 Completed
Actual Enrollment  ICMJE
 (submitted: October 6, 2020)
10
Original Estimated Enrollment  ICMJE
 (submitted: August 17, 2015)
48
Actual Study Completion Date  ICMJE June 2019
Actual Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02527083
Other Study ID Numbers  ICMJE PRO00000878
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party VA Pittsburgh Healthcare System
Study Sponsor  ICMJE VA Pittsburgh Healthcare System
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account VA Pittsburgh Healthcare System
Verification Date October 2020

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