Influence of Anesthetic Technique on Acute and Chronic Neuropathic Pain

Chronic Pain Clinical Trial

Official title:

Influence of Anesthetic Technique on Acute and Chronic Neuropathic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02527083
• Other study ID #: PRO00000878
• Status: Completed
• Phase: Phase 4
• Start date: January 2015
• Est. completion date: June 2019

Study information

• Verified date: October 2020
• Source: VA Pittsburgh Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain
• Anesthesia, Intratracheal
• Anesthesia, Intravenous
• Chronic Pain
• Hernia
• Neuralgia

Intervention

Drug:
• Propofol

• Sevoflurane

• Remifentanil

• Ketamine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
VA Pittsburgh Healthcare System

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Chronic Pain, as measured by the Pain Quality Assessment Scale		1 month, 3 months, 6 months, 12 months
Secondary	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