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

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

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

Study Overview

• Status: Unknown
• Conditions: Postoperative Nausea and Vomiting
• Intervention / Treatment: Other: Ear seeds

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 Type: Interventional
• Enrollment (Anticipated): 270
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: PAULA ORTIZ LUCAS, MD; Phone Number: +34 665987652; Email: paula.ortiz.lucas@gmail.com
• Study Contact Backup: Name: VALENTIN MARTIN, MD, PhD; Email: CoordinadorG6@gmail.com

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Recruiting
    • Fundación Jiménez Díaz Hospital
    • Contact: PAULA ORTIZ LUCAS, MD; Phone Number: +34 665987652; Email: paula.ortiz.lucas@gmail.com
    • Principal Investigator: PAULA ORTIZ LUCAS, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; Patients receive cutaneous stimulation and self-stimulation of acupuncture points Pericardium 6, Heart 7 and Stomach 25	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.
Sham Comparator: Group B; Patients receive cutaneous stimulation and self-stimulation of acupuncture points Gall Bladder 34, Kidney 6 and Liver 3	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Evaluation of the postoperative recovery outcome	Evaluation of the postoperative recovery outcome using the postoperative quality of recovery score QoR-40.	24 hours
Evaluation of perioperative pain	Evaluation of perioperative pain using the verbal numerical pain scale	72 hours
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
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
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

Collaborators and Investigators

• Sponsor: Group G-6
• Investigators: Principal Investigator: PAULA ORTIZ LUCAS, MD, Grupo G6

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): April 1, 2013

Study Registration Dates

• First Submitted: September 26, 2011
• First Submitted That Met QC Criteria: September 27, 2011
• First Posted (Estimate): September 28, 2011

Study Record Updates

• Last Update Posted (Estimate): October 3, 2012
• Last Update Submitted That Met QC Criteria: October 2, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: PONV; ACUPUNCTURE
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting
• Other Study ID Numbers: GE6-ACU-2011-01