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Completed

NCT Number: NCT01722253

Postoperative Analgesia After Low Frequency Electroacupuncture

The purpose of this study is to determine whether electroacupuncture is a effective tool to the postoperative analgesia

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Key information

Conditions

Inguinal Hernia Agnosia Hernia Hernia, Abdominal Hernia, Inguinal Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

Male

Study type

Observational

Primary location

Aristotle University

Thessaloniki, 54124, Greece

About this study

The electroacupuncture is a known therapeutic modality with particular application to pain. In this study the investigators investigate the effect of electroacupuncture in condition of surgery, which is a particularly painful situation. The investigators will verify the postoperative analgesia, as patients will receive either electroacupuncture or placebo electroacupuncture.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy male volunteers
  • 18-75 years old

Exclusion criteria

  • bilateral or recurrent hernia
  • significant cardiovascular, pulmonary, renal, hepatic, neurological disease
  • psychiatric history
  • use of opioids until the last month
  • body mass index greater than 30
  • treatment with beta-blockers
  • aged over 75
  • previous experience with acupuncture
  • hypersensitivity to opioids
  • pacemaker patient
  • patients being treated with monoamine oxidase inhibitors and selective serotonin reuptake inhibitors.

Treatment and study plan

electroacupuncture

Procedure

Electrical stimulation device with frequency 2 Hz and 'frequency scanning mode'

Primary outcomes

  1. Monitoring of pain with the Visual Analogue scale within the first 24 hours after surgery

    Time frame: within the first 24 hours after surgery

    Monitoring of pain with the Visual Analogue scale performed preoperatively and at 30, 90 min, 10 hours and 24 hours after surgery

Secondary outcomes

  1. Control of anxiety with the State-Trait Anxiety Inventory within 24 hours after surgery

    Time frame: within the first 24 hours after surgery

    The State-Trait Anxiety Inventory performed preoperatively and at 30, 90 min, 10 hours and 24 hours after surgery

Other outcomes

  1. Monitoring of pain with the use of an algometer within the first 24 hours after surgery

    Time frame: within the first 24 hours after surgery

    Monitoring of pain with the use of an algometer performed preoperatively and at 30, 90 min, 10 hours and 24 hours after surgery

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Official study title

Postoperative Analgesia After Low Frequency Electroacupuncture as Adjunctive Therapy in Inguinal Hernia Surgery With Abdominal Wall Mesh Reconstruction

Acronym: LFE

Important dates

Study start
2008
Primary completion
2015
Study completion
2015
First posted
Nov 6, 2012
Registry last updated
Jun 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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