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

NCT ID: NCT01579786

Last Updated: 2014-02-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2014-02-28

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

Conditions

Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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)

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

Acetaminophen and acupuncture

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Other Intervention Names

Acupuncture

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Padova

OTHER

Sponsor Role: lead

Responsible Party

Donato Nitti

Ordinary Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Professor Nitti, Donato

Role: STUDY_DIRECTOR

University of Pdova

Locations

Endocrine Unit, Padova Universitary Hospital

Padua, Padova, Italy

Countries

Italy

Other Identifiers

university of padova

Identifier Type: -

Identifier Source: org_study_id