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Clinical Trials/NCT02527083
NCT02527083
Completed
Phase 4

Influence of Anesthetic Technique on Acute and Chronic Neuropathic Pain

VA Pittsburgh Healthcare System0 sites10 target enrollmentStarted: January 1, 2015Last updated:

Overview

Phase
Phase 4
Status
Completed
Enrollment
10
Primary Endpoint
Pain Score, Chronic

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

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.

Arms & Interventions

BIA

Active Comparator

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

Intervention: Sevoflurane (Drug)

BIA

Active Comparator

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

Intervention: Remifentanil (Drug)

TIVA-K

Active Comparator

Total intravenous anesthetic with ketamine

Intervention: Propofol (Drug)

TIVA-K

Active Comparator

Total intravenous anesthetic with ketamine

Intervention: Ketamine (Drug)

TIVA-R

Active Comparator

Total intravenous anesthetic with remifentanil

Intervention: Propofol (Drug)

TIVA-R

Active Comparator

Total intravenous anesthetic with remifentanil

Intervention: Remifentanil (Drug)

Outcomes

Primary Outcomes

Pain Score, Chronic

Time Frame: 1 month, 3 months, 6 months, 12 months

Pain as measured by the Intensity Score of the Pain Quality Assessment Scale (PQAS) at each of the time points after surgery. The scale goes from 0 (no pain) to 10 (the most intense pain sensation imaginable). Higher scores mean worse pain.

Secondary Outcomes

  • Pain Score, Acute(1 day)

Investigators

Sponsor Class
Fed
Responsible Party
Sponsor

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