Influence of Anesthetic Technique on Acute and Chronic Neuropathic Pain

Phase 4

Completed

• Conditions: Hernia; Acute Pain; Anesthesia, Intratracheal; Chronic Pain; Anesthesia, Intravenous
• Interventions: Drug: Sevoflurane; Drug: Propofol; Drug: Remifentanil; Drug: Ketamine

• Registration Number: NCT02527083
• Lead Sponsor: VA Pittsburgh Healthcare System

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 available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-27
• Study First Submitted QC: 2015-08-17
• Study First Posted: 2015-08-18
• Primary Completion: 2019-06
• Study Completion: 2019-06
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-06
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TIVA-R	Remifentanil	Total intravenous anesthetic with remifentanil
BIA	Remifentanil	Balanced Inhalational Anesthesia (consisting of a sevoflurane inhaled anesthestic only)
BIA	Sevoflurane	Balanced Inhalational Anesthesia (consisting of a sevoflurane inhaled anesthestic only)
TIVA-R	Propofol	Total intravenous anesthetic with remifentanil
TIVA-K	Propofol	Total intravenous anesthetic with ketamine
TIVA-K	Ketamine	Total intravenous anesthetic with ketamine

Primary Outcome Measures

Name	Time	Method
Change in Chronic Pain, as measured by the Pain Quality Assessment Scale	1 month, 3 months, 6 months, 12 months

Secondary Outcome Measures

Name	Time	Method
Change in Acute Pain, as measured by the Verbal Response Scale (0-10)	Within 30 minutes after arrival to Post-Operative Care Unit (recovery unit), 1 day