Utility of Acupuncture in the Treatment of Postoperative Nausea and Vomiting in Ambulatory Surgery (PUCTURE-NVPO)

Group G-6

Status: Unknown

Conditions: Postoperative Nausea and Vomiting

Treatments: Other: Ear seeds

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01442012

GE6-ACU-2011-01

Details and patient eligibility

About

To evaluate the Utility of Acupuncture in the Treatment of Postoperative Nausea and Vomiting (PONV) in Ambulatory Surgery.

Full description

Prospective, randomized, comparative study.

The disease to be studied is Postoperative Nausea and Vomiting (PONV). PONV, described by some as "The Big Little Problem", has a great impact on patient´s satisfaction and the postoperative care needed. Considering the increase of outpatient surgery there is an expanding demand for effective PONV treatment to prevent delays in discharge or unplanned readmissions. The estimated annual costs of PONV in the U.S. per year are 100 million Dollars.

Approximately 75 million patients are anesthetized in the world annually. It is estimated that 20-30% of these patients experience PONV, reaching 80% in patients at high risk. This incidence of PONV has maintained despite the improvement in surgical and anesthetic techniques and advances in antiemetic pharmacology. Increasingly, acupuncture is becoming part of Western medicine as a complementary treatment. Acupuncture has been described to effectively reduce the symptoms of different diseases, including PONV.

Enrollment: 270 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients of both sexes, aged 18 years and older.
• ASA I-II patients who will undergo a surgical procedure under general anesthesia in an ambulatory setting.
• Patients who are anticipated to not require admission to the recovery room or intensive care unit.
• Patients who, according to clinical criteria of the acupuncturist physician, are likely to benefit from acupuncture.
• Patients with a sufficient educational level to complete the health questionnaires required in the study.
• Patients who have given their written informed consent to participate in the study.

Exclusion criteria

• Patients with any pathology that under medical discretion makes their participation in the study inadvisable.
• Patients who cannot respond to the questionnaires provided during the study.
• Patients with known hypersensitivity to the materials of the ear seeds.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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270 participants in 2 patient groups

Group A

Active Comparator group

Description:

Patients receive cutaneous stimulation and self-stimulation of acupuncture points Pericardium 6, Heart 7 and Stomach 25

Treatment:

Other: Ear seeds

Group B

Sham Comparator group

Description:

Patients receive cutaneous stimulation and self-stimulation of acupuncture points Gall Bladder 34, Kidney 6 and Liver 3

Treatment:

Other: Ear seeds