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

February 19, 2014 updated by: Donato Nitti, University of Padova

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

121

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Padova, Italy, 35128
        • Endocrine Unit, Padova Universitary Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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
Other Names:
  • Acupuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within the 3rd postoperative day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within the 3rd postoperative day

Other Outcome Measures

Outcome Measure
Time Frame
Remifentanil consumption
Time Frame: Intraoperative
Intraoperative
Acetaminophen
Time Frame: within 7 days after surgery
within 7 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Padova

Investigators

  • Study Director: Professor Nitti, Donato, University of Pdova

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Anticipated)

February 1, 2014

Study Registration Dates

First Submitted

April 3, 2012

First Submitted That Met QC Criteria

April 16, 2012

First Posted (Estimate)

April 18, 2012

Study Record Updates

Last Update Posted (Estimate)

February 20, 2014

Last Update Submitted That Met QC Criteria

February 19, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • university of padova

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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