Postoperative Nausea and VomitingPUCTURE-NVPONCT01442012
Utility of Acupuncture in the Treatment of Postoperative Nausea and Vomiting in Ambulatory Surgery
A study testing Ear seeds in people with Postoperative Nausea and Vomiting, run by Group G-6 at 1 site in Spain.
Trial summary
To evaluate the Utility of Acupuncture in the Treatment of Postoperative Nausea and Vomiting (PONV) in Ambulatory Surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Ear seeds
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2011to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
VALENTIN MARTIN, MD, PhD contact
Spain1 site, 1 recruiting
- Recruiting
Fundacion Jimenez Diaz Hospital
Madrid, Madrid, 28040
PAULA ORTIZ LUCAS, MD, +34 665987652, paula.ortiz.lucas@gmail.com
PAULA ORTIZ LUCAS, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- Ear seeds
- Keywords
- PONV, ACUPUNCTURE
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ear seedsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Patients receive cutaneous stimulation and self-stimulation of acupuncture points Pericardium 6, Heart 7 and Stomach 25 Receives: Other: Ear seeds |
| Group B | Sham comparator | Patients receive cutaneous stimulation and self-stimulation of acupuncture points Gall Bladder 34, Kidney 6 and Liver 3 Receives: Other: Ear seeds |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 72 hours
Secondary outcomes (6)
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.
Measured: 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.
Measured: 24 hours
Evaluation of perioperative pain
Evaluation of perioperative pain using the verbal numerical pain scale
Measured: 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)
Measured: 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
Measured: 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
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2012 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Group G-6
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- PAULA ORTIZ LUCAS, MD, Principal investigator, GRUPO G6
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01442012
- Sponsor's protocol ID
- GE6-ACU-2011-01
- Acronym
- PUCTURE-NVPO
- Status last verified
- Oct 2012
- First submitted
- 26 Sep 2011
- Last updated
- 3 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Evaluate the Utility of Acupuncture in the Treatment of Postoperative Nausea and Vomiting (PONV) in Ambulatory Surgery
- ClinicalTrials.gov ID
- NCT01442012
- Acronym / sponsor ID
- PUCTURE-NVPO / GE6-ACU-2011-01
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- PONV, ACUPUNCTURE
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Group G-6Research network
- Study start
- Sep 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 28 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: Ear seedsPatients receive cutaneous stimulation and self-stimulation of acupuncture points Pericardium 6, Heart 7 and Stomach 25 |
| Group B | Sham comparator | Other: Ear seedsPatients receive cutaneous stimulation and self-stimulation of acupuncture points Gall Bladder 34, Kidney 6 and Liver 3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ear seedsThe 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. | Other | Group A, Group B |
Primary outcome
Percentage of patients with a score <50 on the PONV Intensity Scale at 72 hours postoperatively.
Time frame: 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.
6 secondary outcomes
Percentage of patients with a score <50 on the PONV Intensity Scale at 6 and 24 hours postoperatively.
Time frame: 6 and 24 hours
Evaluation of the postoperative recovery outcome
Time frame: 24 hours
Evaluation of perioperative pain
Time frame: 72 hours
Assessment of the patient´s satisfaction with the perioperative care
Time frame: 72 hours
Assessment of costs and economic impact of the disease
Time frame: 72 hours
Assessment of need for rescue antiemetic medication
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
VALENTIN MARTIN, MD, PhD contact
PAULA ORTIZ LUCAS, MD principal investigator
GRUPO G6
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ear seeds in people with Postoperative Nausea and Vomiting, run by Group G-6 at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact PAULA ORTIZ LUCAS, MD (+34 665987652, paula.ortiz.lucas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with a score <50 on the PONV Intensity Scale at 72 hours postoperatively. (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2012.