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

NCT01442012 | Unknown

• 1 other identifier: GE6-ACU-2011-01
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postoperative Nausea and Vomiting

Keywords

PONV; ACUPUNCTURE

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Percentage of patients with a score <50 on the PONV Intensity Scale at 6 and 24 hours postoperatively.

  6 and 24 hours

• Evaluation of the postoperative recovery outcome

  24 hours

• Evaluation of perioperative pain

  72 hours

• Assessment of the patient´s satisfaction with the perioperative care

  72 hours

• Assessment of costs and economic impact of the disease

  72 hours

Study Arms (2)

Group A

ACTIVE COMPARATOR

Patients receive cutaneous stimulation and self-stimulation of acupuncture points Pericardium 6, Heart 7 and Stomach 25

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

Other: Ear seeds

Interventions

Ear seeds OTHER

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.

Group A; Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Group G-6: lead

Study Sites (1)

Fundacion Jimenez Diaz Hospital

Madrid, Madrid, 28040, Spain

RECRUITING

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Study Officials

• PAULA ORTIZ LUCAS, MD

  GRUPO G6

  PRINCIPAL INVESTIGATOR

Central Study Contacts

PAULA ORTIZ LUCAS, MD

CONTACT

+34 665987652; paula.ortiz.lucas@gmail.com

VALENTIN MARTIN, MD, PhD

CONTACT

CoordinadorG6@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2011
• First Posted: September 28, 2011
• Study Start: September 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: April 1, 2013
• Last Updated: October 3, 2012

Record last verified: 2012-10

Locations

ES (1)