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Influence of Anesthetic Technique on Acute and Chronic Neuropathic Pain

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ClinicalTrials.gov Identifier: NCT02527083
Recruitment Status : Active, not recruiting
First Posted : August 18, 2015
Last Update Posted : May 10, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Acute Pain Chronic Pain Hernia Anesthesia, Intravenous Anesthesia, Intratracheal Drug: Propofol Drug: Sevoflurane Drug: Remifentanil Drug: Ketamine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Influence of Anesthetic Technique on Acute and Chronic Neuropathic Pain
Study Start Date : January 2015
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Arm Intervention/treatment
Active Comparator: BIA
Balanced Inhalational Anesthesia (consisting of a sevoflurane inhaled anesthestic only)
Drug: Sevoflurane
Drug: Remifentanil
Active Comparator: TIVA-K
Total intravenous anesthetic with ketamine
Drug: Propofol
Drug: Ketamine
Active Comparator: TIVA-R
Total intravenous anesthetic with remifentanil
Drug: Propofol
Drug: Remifentanil



Primary Outcome Measures :
  1. Change in Chronic Pain, as measured by the Pain Quality Assessment Scale [ Time Frame: 1 month, 3 months, 6 months, 12 months ]

Secondary Outcome Measures :
  1. Change in Acute Pain, as measured by the Verbal Response Scale (0-10) [ Time Frame: Within 30 minutes after arrival to Post-Operative Care Unit (recovery unit), 1 day ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

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Responsible Party: VA Pittsburgh Healthcare System
ClinicalTrials.gov Identifier: NCT02527083     History of Changes
Other Study ID Numbers: PRO00000878
First Posted: August 18, 2015    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
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Chronic Pain
Neuralgia
Acute Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Propofol
Ketamine
Anesthetics
Sevoflurane
Remifentanil
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Platelet Aggregation Inhibitors