Post Operative PainNCT01579786
Treatment of Post Operative Pain in Thyroid Surgery Patients: Perspective Study Acupuncture Versus Drugs
A study testing Acetaminophen and acupuncture in people with Post Operative Pain, run by University of Padova at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Acetaminophen and acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteItaly
- Study dates
- May 2011to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- thyroid surgery patients
Who cannot join
- back severe arthritis
- osteoporosis
- myofascial pain
- rheumatic disease
- fibromyalgia
- systemic cardiovascular and respiratory disease
Show all 12Show fewer
- hypertension
- drug or alcohol consumption
- mental disease
- cervical trauma
- chronic use of antidepressant
- hypnotic and antihypertensive drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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
- Conditions
- Post Operative Pain
- Being tested
- Acetaminophen and acupuncture
- Keywords
- post operative pain, acupuncture
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetaminophen and acupunctureProcedure or surgery
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| Acetaminophen | No intervention | 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) |
| Acetaminophen and acupuncture | Experimental | 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 Receives: Procedure: Acetaminophen and acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
Change in intensity of pain from first day after operation and during the seven days after performing surgery
Measured: within the 3rd postoperative day
Secondary outcomes (1)
Mc Gill Questionnaire pain
Change in intensity of pain from the day after operation and during all seven days after performing surgery
Measured: within the 3rd postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2012 (estimated)
- Study startMay 2011
- Primary completionDec 2012
- Study completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Donato Nitti, University of Padova
- Investigators
- Professor Nitti, Donato, Study director, University of Pdova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01579786
- Sponsor's protocol ID
- university of padova
- Status last verified
- Feb 2014
- First submitted
- 3 Apr 2012
- Last updated
- 20 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Treatment of Post Operative Pain in Thyroid Surgery Patients: Perspective Study Acupuncture Versus Pharmacological Treatment
- ClinicalTrials.gov ID
- NCT01579786
- Acronym / sponsor ID
- university of padova
- Conditions
- Post Operative Pain
- Keywords
- post operative pain, acupuncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 121 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Feb 2014 (estimated)
- First posted
- 18 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetaminophen | No intervention | –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) |
| Acetaminophen and acupuncture | Experimental | Procedure: Acetaminophen and acupunctureB 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- thyroid surgery patients
Key exclusion criteria (12 listed)
- back severe arthritis
- osteoporosis
- myofascial pain
- rheumatic disease
- fibromyalgia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetaminophen and acupunctureAlso: AcupunctureAll 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 | Procedure or surgery | Acetaminophen and acupuncture |
Primary outcome
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
1 secondary outcome
Mc Gill Questionnaire pain
Time frame: within the 3rd postoperative day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Professor Nitti, Donato study director
University of Pdova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acetaminophen and acupuncture in people with Post Operative Pain, run by University of Padova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: within the 3rd postoperative day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2014.