Overview

This trial is active, not recruiting.

Condition post operative pain
Treatment acetaminophen and acupuncture
Sponsor University of Padova
Start date May 2011
End date December 2012
Trial size 121 participants
Trial identifier NCT01579786, university of padova

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (caregiver, outcomes assessor)
Primary purpose treatment
Arm
(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)
(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
acetaminophen and acupuncture 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

Primary Outcomes

Measure
Visual Analogue Scale
time frame: within the 3rd postoperative day

Secondary Outcomes

Measure
Mc Gill Questionnaire pain
time frame: within the 3rd postoperative day

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title The Treatment of Post Operative Pain in Thyroid Surgery Patients: Perspective Study Acupuncture Versus Pharmacological Treatment
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
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by University of Padova.