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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01722253
Other study ID # 225
Secondary ID
Status Completed
Phase Phase 0
First received November 3, 2012
Last updated June 4, 2015
Start date December 2008
Est. completion date April 2015

Study information

Verified date June 2015
Source Aristotle University Of Thessaloniki
Contact n/a
Is FDA regulated No
Health authority Greece: Ethics Committee
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date April 2015
Est. primary completion date March 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 75 Years
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Procedure:
Electroacupuncture
Electrical stimulation device with frequency 2 Hz and 'frequency scanning mode'

Locations

Country Name City State
Greece Aristotle University Thessaloniki

Sponsors (1)

Lead Sponsor Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Other Monitoring of pain with the use of an algometer 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 Yes
Primary Monitoring of pain with the Visual Analogue scale 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 Yes
Secondary Control of anxiety with the State-Trait Anxiety Inventory within 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 Yes
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