Influence of Anesthetic Technique on Acute and Chronic Neuropathic Pain

NCT02527083 | Completed Phase 4 Results

• 1 other identifier: PRO00000878
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Pain; Chronic Pain; Hernia; Anesthesia, Intravenous; Anesthesia, Intratracheal

Outcome Measures

Primary Outcomes (1)

• Pain Score, Chronic

  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.

  1 month, 3 months, 6 months, 12 months

Secondary Outcomes (1)

• Pain Score, Acute

  1 day

Study Arms (3)

BIA

ACTIVE COMPARATOR

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

Drug: Sevoflurane; Drug: Remifentanil

TIVA-K

ACTIVE COMPARATOR

Total intravenous anesthetic with ketamine

Drug: Propofol; Drug: Ketamine

TIVA-R

ACTIVE COMPARATOR

Total intravenous anesthetic with remifentanil

Drug: Propofol; Drug: Remifentanil

Interventions

Sevoflurane DRUG

Also known as: Ultane

BIA

Remifentanil DRUG

Also known as: Ultiva

BIA; TIVA-R

Ketamine DRUG

Also known as: Ketalar

TIVA-K

Propofol DRUG

Also known as: Diprivan

TIVA-K; TIVA-R

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All male patients undergoing herniorrhaphy surgery that requires general anesthesia.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Pittsburgh Healthcare System: lead

MeSH Terms

Conditions

Acute Pain; Chronic Pain; Hernia

Interventions

Propofol; Sevoflurane; Remifentanil; Ketamine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic

Results Point of Contact

• Title: James Ibinson, MD, PhD
• Organization: VA Pittsburgh Healthcare System

james.ibinson@va.gov

412-360-1484

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2015
• First Posted: August 18, 2015
• Study Start: January 1, 2015
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: December 31, 2025
• Results First Posted: December 31, 2025

Record last verified: 2021-05