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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Group G-6
Sponsor:
Information provided by (Responsible Party):
Group G-6
ClinicalTrials.gov Identifier:
NCT01442012
First received: September 26, 2011
Last updated: October 2, 2012
Last verified: October 2012

September 26, 2011
October 2, 2012
September 2011
December 2012   (final data collection date for primary outcome measure)
Percentage of patients with a score <50 on the PONV Intensity Scale at 72 hours postoperatively. [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
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.
Percentage of patients with a score <50 on the PONV Intensity Scale(defined as not clinically significant) at 72 hours postoperatively. [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
Percentage of patients with a score <50 on the PONV Intensity Scale (defined as not clinically significant) at 72 hours postoperatively. In the experimental group, patients received cutaneous stimulation and self-stimulation of acupuncture points Pericardium 6, Heart 7 and Stomach 25, compared with the control group of patients who receive cutaneous stimulation and self-stimulation of acupuncture points Gall Bladder 34, Kidney 6 and Liver 3 (placebo group).
Complete list of historical versions of study NCT01442012 on ClinicalTrials.gov Archive Site
  • Percentage of patients with a score <50 on the PONV Intensity Scale at 6 and 24 hours postoperatively. [ Time Frame: 6 and 24 hours ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Evaluation of the postoperative recovery outcome using the postoperative quality of recovery score QoR-40.
  • Evaluation of perioperative pain [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
    Evaluation of perioperative pain using the verbal numerical pain scale
  • Assessment of the patient´s satisfaction with the perioperative care [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
    Assessment of costs and economic impact of the disease quantifying the use of health and non-health resources
  • Assessment of need for rescue antiemetic medication [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
    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(defined as not clinically significant) at 6 and 24 hours postoperatively. [ Time Frame: 6 and 24 hours ] [ Designated as safety issue: Yes ]
    Percentage of patients with a score <50 on the PONV Intensity Scale (defined as not clinically significant) at 6 and 24 hours postoperatively. In the experimental group, patients received cutaneous stimulation and self-stimulation of acupuncture points Pericardium 6, Heart 7 and Stomach 25, compared with the control group of patients who receive cutaneous stimulation and self-stimulation of acupuncture points Gall Bladder 34, Kidney 6 and Liver 3 (placebo group).
  • Assessment of health status in the perioperative [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Depending on the postoperative quality of recovery score QoR-40
  • Evaluation of perioperative pain [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
    Using the verbal numerical pain scale
  • Assessment of patient satisfaction with perioperative care [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
    Using the Leiden perioperative patient satisfaction questionnaire(LPPSq)
  • Assessment of costs and economic impact of the disease [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
    Quantifying the use of health resources and non-health resources
  • Assessment of need for rescue antiemetic medication [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
    Quantification of the percentage of patients who needed two or more drugs with antiemetic action as rescue medication
Not Provided
Not Provided
 
Utility of Acupuncture in the Treatment of Postoperative Nausea and Vomiting in Ambulatory Surgery
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Postoperative Nausea and Vomiting
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.
  • Active Comparator: Group A
    Patients receive cutaneous stimulation and self-stimulation of acupuncture points Pericardium 6, Heart 7 and Stomach 25
    Intervention: Other: Ear seeds
  • Sham Comparator: Group B
    Patients receive cutaneous stimulation and self-stimulation of acupuncture points Gall Bladder 34, Kidney 6 and Liver 3
    Intervention: Other: Ear seeds
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
270
April 2013
December 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact: PAULA ORTIZ LUCAS, MD +34 665987652 paula.ortiz.lucas@gmail.com
Contact: VALENTIN MARTIN, MD, PhD CoordinadorG6@gmail.com
Spain
 
NCT01442012
GE6-ACU-2011-01
No
Group G-6
Group G-6
Not Provided
Principal Investigator: PAULA ORTIZ LUCAS, MD GRUPO G6
Group G-6
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP