Postoperative Analgesia After Low Frequency Electroacupuncture
LFE
1 other identifier
observational
54
1 country
1
Brief Summary
The purpose of this study is to determine whether electroacupuncture is a effective tool to the postoperative analgesia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2008
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 3, 2012
CompletedFirst Posted
Study publicly available on registry
November 6, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedJune 8, 2015
June 1, 2015
6.2 years
November 3, 2012
June 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Control of anxiety with the State-Trait Anxiety Inventory within 24 hours after surgery
within the first 24 hours after surgery
Other Outcomes (1)
Monitoring of pain with the use of an algometer within the first 24 hours after surgery
within the first 24 hours after surgery
Study Arms (1)
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.
Interventions
Electrical stimulation device with frequency 2 Hz and 'frequency scanning mode'
Eligibility Criteria
Patients in the Surgical Clinic with right or left inguinal hernia, residents of Thessaly, Greece.
You may qualify if:
- healthy male volunteers
- years old
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aristotle University
Thessaloniki, Thessaloniki, 54124, Greece
Related Publications (1)
Dalamagka M, Mavrommatis C, Grosomanidis V, Karakoulas K, Vasilakos D. Postoperative analgesia after low-frequency electroacupuncture as adjunctive treatment in inguinal hernia surgery with abdominal wall mesh reconstruction. Acupunct Med. 2015 Oct;33(5):360-7. doi: 10.1136/acupmed-2014-010689. Epub 2015 Jun 3.
PMID: 26040491DERIVED
Biospecimen
serum, plasma
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Dimitrios G Vasilakos, Professor
Aristotle University
- PRINCIPAL INVESTIGATOR
Maria I Dalamagka, consultant
Aristotle University
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- consultant Anaesthesiologist
Study Record Dates
First Submitted
November 3, 2012
First Posted
November 6, 2012
Study Start
December 1, 2008
Primary Completion
March 1, 2015
Study Completion
April 1, 2015
Last Updated
June 8, 2015
Record last verified: 2015-06