Utility of Acupuncture in the Treatment of Postoperative Nausea and Vomiting in Ambulatory Surgery

Postoperative Nausea and Vomiting Clinical Trial

— PUCTURE-NVPO  

Official title:

Randomized Clinical Trial to Evaluate the Utility of Acupuncture in the Treatment of Postoperative Nausea and Vomiting (PONV) in Ambulatory Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01442012
• Other study ID #: GE6-ACU-2011-01
• Status: Recruiting
• Phase: N/A
• First received: September 26, 2011
• Last updated: October 2, 2012
• Start date: September 2011
• Est. completion date: April 2013

Study information

• Verified date: October 2012
• Source: Group G-6
• Contact: PAULA ORTIZ LUCAS, MD
• Phone: +34 665987652
• Email: paula.ortiz.lucas[@]gmail.com
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: April 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Other:
• Ear seeds
The investigators will use ear seeds to stimulate acupuncture points. The seeds will be applied when the patients are in the preoperative room. After the patients have been discharged, they will need to stimulate these points every eight hours for five minutes, and every time they have nausea and/or vomiting during the first three postoperative days.

Locations

Country	Name	City	State
Spain	Fundacion Jimenez Diaz Hospital	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Group G-6

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with a score <50 on the PONV Intensity Scale at 72 hours postoperatively.	The percentage of patients with a score <50 on the PONV Intensity Scale (defined as clinically not significant PONV) at 72 hours postoperatively will be assessed in the experimental and control group, respectively. In the experimental group, patients receive cutaneous stimulation and self-stimulation of acupuncture points Pericardium 6, Heart 7 and Stomach 25. In the control (placebo) group, patients receive cutaneous stimulation and self-stimulation of acupuncture points Gall Bladder 34, Kidney 6 and Liver 3.	72 hours	Yes
Secondary	Percentage of patients with a score <50 on the PONV Intensity Scale at 6 and 24 hours postoperatively.	The percentage of patients with a score <50 on the PONV Intensity Scale (defined as clinically not significant PONV) at 6 und 24 hours postoperatively will be assessed in the experimental and control group, respectively. In the experimental group, patients receive cutaneous stimulation and self-stimulation of acupuncture points Pericardium 6, Heart 7 and Stomach 25. In the control (placebo) group, patients receive cutaneous stimulation and self-stimulation of acupuncture points Gall Bladder 34, Kidney 6 and Liver 3.	6 and 24 hours	Yes
Secondary	Evaluation of the postoperative recovery outcome	Evaluation of the postoperative recovery outcome using the postoperative quality of recovery score QoR-40.	24 hours	Yes
Secondary	Evaluation of perioperative pain	Evaluation of perioperative pain using the verbal numerical pain scale	72 hours	Yes
Secondary	Assessment of the patient´s satisfaction with the perioperative care	Assessment of the patient´s satisfaction with the perioperative care using the Leiden perioperative patient satisfaction questionnaire (LPPSq)	72 hours	Yes
Secondary	Assessment of costs and economic impact of the disease	Assessment of costs and economic impact of the disease quantifying the use of health and non-health resources	72 hours	Yes
Secondary	Assessment of need for rescue antiemetic medication	Assessment of need for rescue antiemetic medication by quantifying the patients who need two or more drugs with antiemetic effect as rescue medication	72 hours	Yes