Influence of Anesthetic Technique on Acute and Chronic Neuropathic Pain

October 6, 2020 updated by: VA Pittsburgh Healthcare System
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: BIA
Balanced Inhalational Anesthesia (consisting of a sevoflurane inhaled anesthestic only)
Drug: Sevoflurane
Drug: Remifentanil
ACTIVE_COMPARATOR: TIVA-K
Total intravenous anesthetic with ketamine
Drug: Propofol
Drug: Ketamine
ACTIVE_COMPARATOR: TIVA-R
Total intravenous anesthetic with remifentanil
Drug: Propofol
Drug: Remifentanil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Chronic Pain, as measured by the Pain Quality Assessment Scale
Time Frame: 1 month, 3 months, 6 months, 12 months
1 month, 3 months, 6 months, 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Within 30 minutes after arrival to Post-Operative Care Unit (recovery unit), 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Pittsburgh Healthcare System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (ACTUAL)

June 1, 2019

Study Completion (ACTUAL)

June 1, 2019

Study Registration Dates

First Submitted

January 27, 2015

First Submitted That Met QC Criteria

August 17, 2015

First Posted (ESTIMATE)

August 18, 2015

Study Record Updates

Last Update Posted (ACTUAL)

October 8, 2020

Last Update Submitted That Met QC Criteria

October 6, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO00000878

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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