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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Group G-6.
Recruitment status was  Recruiting
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
  Purpose

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


Condition Intervention
Postoperative Nausea and Vomiting
Other: Ear seeds

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Randomized Clinical Trial to Evaluate the Utility of Acupuncture in the Treatment of Postoperative Nausea and Vomiting (PONV) in Ambulatory Surgery

Resource links provided by NLM:


Further study details as provided by Group G-6:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 270
Study Start Date: September 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01442012

Contacts
Contact: PAULA ORTIZ LUCAS, MD +34 665987652 paula.ortiz.lucas@gmail.com
Contact: VALENTIN MARTIN, MD, PhD CoordinadorG6@gmail.com

Locations
Spain
Fundacion Jimenez Diaz Hospital Recruiting
Madrid, Spain, 28040
Contact: PAULA ORTIZ LUCAS, MD    +34 665987652    paula.ortiz.lucas@gmail.com   
Principal Investigator: PAULA ORTIZ LUCAS, MD         
Sponsors and Collaborators
Group G-6
Investigators
Principal Investigator: PAULA ORTIZ LUCAS, MD GRUPO G6
  More Information

No publications provided

Responsible Party: Group G-6
ClinicalTrials.gov Identifier: NCT01442012     History of Changes
Other Study ID Numbers: GE6-ACU-2011-01
Study First Received: September 26, 2011
Last Updated: October 2, 2012
Health Authority: Spain: Ministry of Health

Keywords provided by Group G-6:
PONV
ACUPUNCTURE

Additional relevant MeSH terms:
Nausea
Postoperative Nausea and Vomiting
Vomiting
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on November 25, 2014