Clinical trial NCT01442012: Utility of Acupuncture in the Treatment of Postoperative Nausea and Vomiting in Ambulatory Surgery
Official title: Randomized Clinical Trial to Evaluate the Utility of Acupuncture in the Treatment of Postoperative Nausea and Vomiting (PONV) in Ambulatory Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Nausea and Vomiting
Keywords: PONV
ACUPUNCTURE
Lead sponsor: Group G-6
Sponsor class: NETWORK
First posted: 2011-09-28
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of patients with a score <50 on the PONV Intensity Scale at 72 hours postoperatively.
timeFrame: 72 hours
Secondary outcomes:
measure: Percentage of patients with a score <50 on the PONV Intensity Scale at 6 and 24 hours postoperatively.
timeFrame: 6 and 24 hours
measure: Evaluation of the postoperative recovery outcome
timeFrame: 24 hours
measure: Evaluation of perioperative pain
timeFrame: 72 hours
measure: Assessment of the patient´s satisfaction with the perioperative care
timeFrame: 72 hours
measure: Assessment of costs and economic impact of the disease
timeFrame: 72 hours
measure: Assessment of need for rescue antiemetic medication
timeFrame: 72 hours
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz Hospital
Study officials:
affiliation: GRUPO G6
name: PAULA ORTIZ LUCAS, MD
role: PRINCIPAL_INVESTIGATOR
References: