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

Not Applicable

• Conditions: Postoperative Nausea and Vomiting
• Interventions: Other: Ear seeds

• Registration Number: NCT01442012
• Lead Sponsor: Group G-6

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.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-26
• Study First Submitted QC: 2011-09-27
• Study First Posted: 2011-09-28
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-02
• Last Update Posted: 2012-10-03
• Primary Completion: 2012-12
• Study Completion: 2013-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 270

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Ear seeds	Patients receive cutaneous stimulation and self-stimulation of acupuncture points Pericardium 6, Heart 7 and Stomach 25
Group B	Ear seeds	Patients receive cutaneous stimulation and self-stimulation of acupuncture points Gall Bladder 34, Kidney 6 and Liver 3

Primary Outcome Measures

Name	Time	Method
Percentage of patients with a score <50 on the PONV Intensity Scale at 72 hours postoperatively.	72 hours	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.

Secondary Outcome Measures

Name	Time	Method
Assessment of need for rescue antiemetic medication	72 hours	Assessment of need for rescue antiemetic medication by quantifying the patients who need two or more drugs with antiemetic effect as rescue medication
Percentage of patients with a score <50 on the PONV Intensity Scale at 6 and 24 hours postoperatively.	6 and 24 hours	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.
Evaluation of the postoperative recovery outcome	24 hours	Evaluation of the postoperative recovery outcome using the postoperative quality of recovery score QoR-40.
Evaluation of perioperative pain	72 hours	Evaluation of perioperative pain using the verbal numerical pain scale
Assessment of the patient´s satisfaction with the perioperative care	72 hours	Assessment of the patient´s satisfaction with the perioperative care using the Leiden perioperative patient satisfaction questionnaire (LPPSq)
Assessment of costs and economic impact of the disease	72 hours	Assessment of costs and economic impact of the disease quantifying the use of health and non-health resources

Trial Locations

Locations (1)

Fundacion Jimenez Diaz Hospital; 🇪🇸 Madrid, Spain