Treatment of Post Operative Pain in Thyroid Surgery Patients: Perspective Study Acupuncture Versus Drugs

Post Operative Pain Clinical Trial

Official title:

The Treatment of Post Operative Pain in Thyroid Surgery Patients: Perspective Study Acupuncture Versus Pharmacological Treatment

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01579786
• Other study ID #: university of padova
• Status: Active, not recruiting
• Phase: N/A
• First received: April 3, 2012
• Last updated: February 19, 2014
• Start date: May 2011
• Est. completion date: February 2014

Study information

• Verified date: February 2014
• Source: University of Padova
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The aim of the study was to evaluate if acupuncture may reduce intraoperative ULTIVA (remifentanil) consumption and post operative pain measured with VAS, italian version Mc Gill Questionnaire Pain and drug consumption (acetaminophen daily consumption).

Description:

The aim of the study was to evaluate if acupuncture may reduce intraoperative ULTIVA (remifentanil) consumption and post operative pain measured with VAS, italian version Mc Gill Questionnaire Pain and drug consumption (acetaminophen daily consumption). The study involve patients who underwent thyroid surgery randomised in two groups. A group patients treated with drugs and B group patients treated with drugs and acupuncture.Acupuncture related risk are pain, faint and haematoma.The study will be done in Padova University Hospital (Endocrine Unit.Primary end point will be VAS pain and secondary end points ULTIVA consumption, post operative pain measured with italian version of Mc Gill Questionnaire Pain and acetaminophen daily intake

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 121
• Est. completion date: February 2014
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• thyroid surgery patients

Exclusion Criteria:

• back severe arthritis

• osteoporosis

• myofascial pain

• rheumatic disease

• fibromyalgia

• systemic cardiovascular and respiratory disease

• hypertension

• drug or alcohol consumption

• mental disease

• cervical trauma

• chronic use of antidepressant

• hypnotic and antihypertensive drugs

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Procedure:
• Acetaminophen and acupuncture
All patients will receive acetaminophen (maximum 3g/day) for all seven days after surgery and will receive acupuncture treatment at first day after performing surgery and thirty minutes before operation

Locations

Country	Name	City	State
Italy	Endocrine Unit, Padova Universitary Hospital	Padova

Sponsors (1)

Lead Sponsor	Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Remifentanil consumption		Intraoperative	Yes
Other	Acetaminophen		within 7 days after surgery	Yes
Primary	Visual Analogue Scale	Change in intensity of pain from first day after operation and during the seven days after performing surgery	within the 3rd postoperative day	Yes
Secondary	Mc Gill Questionnaire pain	Change in intensity of pain from the day after operation and during all seven days after performing surgery	within the 3rd postoperative day	Yes