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Influence of Anesthetic Technique on Acute and Chronic Neuropathic Pain

NCT ID: NCT02527083

Last Updated: 2025-12-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2019-06-30

Brief Summary

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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

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Conditions

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Acute Pain Chronic Pain Hernia Anesthesia, Intravenous Anesthesia, Intratracheal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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BIA

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

Group Type ACTIVE_COMPARATOR

Sevoflurane

Intervention Type DRUG

Remifentanil

Intervention Type DRUG

TIVA-K

Total intravenous anesthetic with ketamine

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

Ketamine

Intervention Type DRUG

TIVA-R

Total intravenous anesthetic with remifentanil

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

Remifentanil

Intervention Type DRUG

Interventions

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Propofol

Intervention Type DRUG

Sevoflurane

Intervention Type DRUG

Remifentanil

Intervention Type DRUG

Ketamine

Intervention Type DRUG

Other Intervention Names

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Diprivan Ultane Ultiva Ketalar

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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VA Pittsburgh Healthcare System

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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PRO00000878

Identifier Type: -

Identifier Source: org_study_id