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

NCT01579786 | Unknown DMC

• 1 other identifier: university of padova
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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).

Conditions

Post Operative Pain

Keywords

post operative pain; acupuncture

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale

  Change in intensity of pain from first day after operation and during the seven days after performing surgery

  within the 3rd postoperative day

Secondary Outcomes (1)

• Mc Gill Questionnaire pain

  within the 3rd postoperative day

Other Outcomes (2)

• Remifentanil consumption

  Intraoperative

• Acetaminophen

  within 7 days after surgery

Study Arms (2)

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

Procedure: Acetaminophen and acupuncture

Interventions

Acetaminophen and acupuncture 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

Also known as: Acupuncture

Acetaminophen and acupuncture

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• thyroid surgery patients

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

Endocrine Unit, Padova Universitary Hospital

Padua, Padova, 35128, Italy

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Acetaminophen; Acupuncture Therapy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Complementary Therapies; Therapeutics

Study Officials

• Professor Nitti, Donato

  University of Pdova

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ordinary Professor of Surgery

Study Record Dates

• First Submitted: April 3, 2012
• First Posted: April 18, 2012
• Study Start: May 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: February 1, 2014
• Last Updated: February 20, 2014

Record last verified: 2014-02

Locations

IT (1)