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

This study is currently recruiting participants.
Verified April 2012 by University of Padova
Sponsor:
Information provided by (Responsible Party):
Donato Nitti, University of Padova
ClinicalTrials.gov Identifier:
NCT01579786
First received: April 3, 2012
Last updated: April 21, 2012
Last verified: April 2012
History of Changes
  Purpose

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).


Condition Intervention
Post Operative Pain
 Procedure: Acetaminophen and acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Treatment of Post Operative Pain in Thyroid Surgery Patients: Perspective Study Acupuncture Versus Pharmacological Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Padova:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 120
Study Start Date: May 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 and the third day after surgery and thirty minutes after 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 and third day after performing surgery and thirty minutes after operation
Other Name: Acupuncture

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01579786

Contacts
Contact: Maurizio Iacobone +390498211815 maurizio.iacobone@unipd.it
Contact: simone zanella +393493412197 simonezanella@katamail.com

Locations
Italy
Endocrine Unit, Padova Universitary Hospital Recruiting
Padova, Italy, 35128
Contact: maurizio iacobone     +390498211815     maurizio.iacobone@unipd.it    
Contact: simone zanella     +393493412197     simonezanella@katamail.com    
Sponsors and Collaborators
University of Padova
Investigators
Study Director: Professor Nitti, Donato University of Pdova
  More Information

No publications provided

Responsible Party: Donato Nitti, Ordinary Professor of Surgery, University of Padova
ClinicalTrials.gov Identifier: NCT01579786     History of Changes
Other Study ID Numbers: university of padova
Study First Received: April 3, 2012
Last Updated: April 21, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by University of Padova:
post operative pain
acupuncture

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Acetaminophen
Antipyretics
Physiological Effects of Drugs
 Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013