Postoperative Analgesia After Low Frequency Electroacupuncture

Inguinal Hernia Clinical Trial

— LFE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01722253
• Other study ID #: 225
• 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

• Hernia, Inguinal
• Inguinal Hernia

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