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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02527083
Other study ID # PRO00000878
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


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
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