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

Not Applicable

• Conditions: Post Operative Pain
• Interventions: Procedure: Acetaminophen and acupuncture

• Registration Number: NCT01579786
• Lead Sponsor: University of Padova

Brief 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).

Detailed 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

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2012-04-03
• Study First Submitted QC: 2012-04-16
• Study First Posted: 2012-04-18
• Primary Completion: 2012-12
• Status Verified: 2014-02
• Study Completion: 2014-02
• Last Update Submitted: 2014-02-19
• Last Update Posted: 2014-02-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 121

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acetaminophen and acupuncture	Acetaminophen and acupuncture	B group patients. All patients will receive the standard pharmacological treatment for the operation. Acetaminophen (maximum 3g/day) during all seven days after surgery and patients will be treated with acupuncture the first day after surgery and thirty minutes before the surgical procedure

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale	within the 3rd postoperative day	Change in intensity of pain from first day after operation and during the seven days after performing surgery

Secondary Outcome Measures

Name	Time	Method
Mc Gill Questionnaire pain	within the 3rd postoperative day	Change in intensity of pain from the day after operation and during all seven days after performing surgery

Trial Locations

Locations (1)

Endocrine Unit, Padova Universitary Hospital; 🇮🇹 Padova, Italy