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
About this trial
This is an interventional prevention trial for Acute Pain
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.
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
NCT ID
NCT02527083
First Posted
January 27, 2015
Last Updated
October 6, 2020
Sponsor
VA Pittsburgh Healthcare System
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
Learn more about this trial
Influence of Anesthetic Technique on Acute and Chronic Neuropathic Pain
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