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

Overview

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).

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: December 2012

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

Interventions

  • 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

Arms, Groups and Cohorts

  • No Intervention: Acetaminophen
    • A group All patients will be treated only with drugs used for this type during the operation and post operative pain controlled with usual acetaminophen drug administration (maximum 3 g/day)
  • Experimental: 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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Padova
  • Provider of Information About this Clinical Study
    • Principal Investigator: Donato Nitti, Ordinary Professor of Surgery – University of Padova
  • Overall Official(s)
    • Professor Nitti, Donato, Study Director, University of Pdova

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