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

Primary Purpose

Post Operative Pain

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Acetaminophen and acupuncture
Sponsored by
University of Padova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain focused on measuring post operative pain, acupuncture

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Endocrine Unit, Padova Universitary Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Acetaminophen

Acetaminophen and acupuncture

Arm Description

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)

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

Outcomes

Primary Outcome Measures

Visual Analogue Scale
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
Change in intensity of pain from the day after operation and during all seven days after performing surgery

Full Information

First Posted
April 3, 2012
Last Updated
February 19, 2014
Sponsor
University of Padova
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1. Study Identification

Unique Protocol Identification Number
NCT01579786
Brief Title
Treatment of Post Operative Pain in Thyroid Surgery Patients: Perspective Study Acupuncture Versus Drugs
Official Title
The Treatment of Post Operative Pain in Thyroid Surgery Patients: Perspective Study Acupuncture Versus Pharmacological Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
February 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Padova

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
post operative pain, acupuncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acetaminophen
Arm Type
No Intervention
Arm Description
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)
Arm Title
Acetaminophen and acupuncture
Arm Type
Experimental
Arm Description
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 Type
Procedure
Intervention Name(s)
Acetaminophen and acupuncture
Other Intervention Name(s)
Acupuncture
Intervention Description
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
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
Change in intensity of pain from first day after operation and during the seven days after performing surgery
Time Frame
within the 3rd postoperative day
Secondary Outcome Measure Information:
Title
Mc Gill Questionnaire pain
Description
Change in intensity of pain from the day after operation and during all seven days after performing surgery
Time Frame
within the 3rd postoperative day
Other Pre-specified Outcome Measures:
Title
Remifentanil consumption
Time Frame
Intraoperative
Title
Acetaminophen
Time Frame
within 7 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Professor Nitti, Donato
Organizational Affiliation
University of Pdova
Official's Role
Study Director
Facility Information:
Facility Name
Endocrine Unit, Padova Universitary Hospital
City
Padova
ZIP/Postal Code
35128
Country
Italy

12. IPD Sharing Statement

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

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