Postoperative Analgesia After Low Frequency Electroacupuncture (LFE)

June 4, 2015 updated by: Maria I. Dalamagka, Aristotle University Of Thessaloniki

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Thessaloniki, Greece, 54124
        • Aristotle University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Patients in the Surgical Clinic with right or left inguinal hernia, residents of Thessaly, Greece.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
placebo, electroacupuncture

Electroacupuncture before and after surgery (40min and 60 min respectively) with frequency 2 Hz, and 'frequency scanning mode'.

Placebo electroacupuncture, in which the needles are secured (without penetrating the skin) and connected to the electrical device, which is not functional.
Procedure: Electroacupuncture
Electrical stimulation device with frequency 2 Hz and 'frequency scanning mode'

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within the first 24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within the first 24 hours after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within the first 24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aristotle University Of Thessaloniki

Investigators

  • Study Chair: Dimitrios G Vasilakos, Professor, Aristotle University
  • Principal Investigator: Maria I Dalamagka, consultant, Aristotle University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

November 3, 2012

First Submitted That Met QC Criteria

November 5, 2012

First Posted (Estimate)

November 6, 2012

Study Record Updates

Last Update Posted (Estimate)

June 8, 2015

Last Update Submitted That Met QC Criteria

June 4, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 225

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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