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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Donato Nitti, University of Padova
ClinicalTrials.gov Identifier:
NCT01579786
First received: April 3, 2012
Last updated: February 19, 2014
Last verified: February 2014

April 3, 2012
February 19, 2014
May 2011
December 2012   (final data collection date for primary outcome measure)
Visual Analogue Scale [ Time Frame: within the 3rd postoperative day ] [ Designated as safety issue: Yes ]
Change in intensity of pain from first day after operation and during the seven days after performing surgery
Visual Analogue Scale [ Time Frame: within the seven days after operation ] [ Designated as safety issue: Yes ]
Change in intensity of pain from first day after operation and during the seven days after performing surgery
Complete list of historical versions of study NCT01579786 on ClinicalTrials.gov Archive Site
Mc Gill Questionnaire pain [ Time Frame: within the 3rd postoperative day ] [ Designated as safety issue: Yes ]
Change in intensity of pain from the day after operation and during all seven days after performing surgery
Mc Gill Questionnaire pain [ Time Frame: within the seven days after operation ] [ Designated as safety issue: Yes ]
Change in intensity of pain from the day after operation and during all seven days after performing surgery
  • Remifentanil consumption [ Time Frame: Intraoperative ] [ Designated as safety issue: Yes ]
  • Acetaminophen [ Time Frame: within 7 days after surgery ] [ Designated as safety issue: Yes ]
Not Provided
 
Treatment of Post Operative Pain in Thyroid Surgery Patients: Perspective Study Acupuncture Versus Drugs
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).

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Post Operative Pain
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 Name: Acupuncture
  • 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
    Intervention: Procedure: Acetaminophen and acupuncture
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
121
February 2014
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01579786
university of padova
Yes
Donato Nitti, University of Padova
University of Padova
Not Provided
Study Director: Professor Nitti, Donato University of Pdova
University of Padova
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP