Acunausea: Postoperative Nausea/Vomiting and Acupressure

Sponsor
National Research Centre of Complementary and Alternative Medicine, Norway (Other)
Overall Status
Unknown status
CT.gov ID
NCT01389570
Collaborator
Lovisenberg Diakonale Hospital (Other)
2,000
1
1
9
222.2

Study Details

Study Description

Brief Summary

Postoperative nausea and vomiting (PONV) remain a significant challenge in our practice. However, pharmaceutical prophylaxis can confer unpleasant adverse effects. It would therefore be appropriate to consider the use of non-pharmacological methods in preventing PONV. Acupuncture and acupressure are reported to be effective preventive treatment for PONV, and the adverse effects are minimal. Consequently, the aim of the study is to implement acupressure in our anaesthetic department procedures. A reduction of the use of antiemetics will be a parameter on the effectiveness of acupressure. The study will focus on acupressure as a supplement to the ordinary prophylactic treatment of PONV in adults undergoing orthopaedic and general surgery, and adults and children undergoing ear, nose, throat surgery. The primary endpoints are the quantities of antiemetics used before (baseline) and during the implementation period. The study will be conducted from January to December 2011.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Acupressure wrist band
Phase 2

Detailed Description

Background:

Nausea and vomiting after surgery and anaesthesia are inconvenient and undesirable physiological and psychological events. In addition to causing distress and discomfort for the patient, retching and vomiting can increase the risk of pain and bleeding, resultant resource use, and prolong stay at the postoperative ward and hospital. The mechanisms behind Postoperative nausea and vomiting (PONV) are complicated, and many of the trigger factors are still unknown. Several types of pharmaceutical antiemetics are in use, but drug therapy is only partially effective in preventing or treating PONV. In 2008 we conducted a trial to assess the effectiveness of acupuncture and acupressure (acustimulation) in reducing postoperative retching and vomiting in children undergoing tonsillectomy and/or adenoidectomy. The results were promising, and the article is published in Acupuncture in Medicine in March 2011.

Acustimulation:

Cochrane systematic reviews show the effect of acupuncture and acupressure in postoperative antiemetic treatment. The reviews show no clear difference in the effectiveness of P6 acupoint stimulation for adults and children, or for invasive and non-invasive acupoint stimulation. Moreover, there was no reliable evidence for differences in risks of postoperative nausea or vomiting after P6 acupoint stimulation compared to antiemetic drugs.

Aim and objective:

Acupressure wrist bands are less expensive compared to most antiemetics, and the adverse effects of acupoint stimulation are minimal. Accordingly, a reduction in cost-benefit by the use of wristband, is apparent. Considering the results from earlier research along with the promising results from our trial, we are encouraged to implement acupressure into our standard anaesthetic procedures. A reduction of the use of antiemetics will be a parameter on the effectiveness of acupressure.

The aim of this quality improvement study is to implement acupressure as a supplement to the ordinary prophylactic treatment of PONV in our hospital. The objective is to observe whether use of acupressure wristbands reduces the consumption of antiemetics for the treatment of postoperative nausea and vomiting.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
2000 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Postoperative Nausea/Vomiting and Acupressure Can Acupressure With Wristbands Reduce the Use of Antiemetics for the Treatment of Postoperative Nausea and Vomiting?
Study Start Date :
Sep 1, 2011
Anticipated Primary Completion Date :
Dec 1, 2011
Anticipated Study Completion Date :
Jun 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Acupressure wrist band

The group receiving acupressure wrist band

Procedure: Acupressure wrist band
Use of acupressure wristband during surgery Manufacturer; Pinnacle Ind Ltd, Rm 831 Thriving Ind Ctr, 26-38 Sha Tsui Rd, Tsuen Wan, Hong Kong
Other Names:
  • Sea-Band Ltd
  • Outcome Measures

    Primary Outcome Measures

    1. Effectiveness of acupressure for postoperative nausea in terms of less use of antiemetic drugs [one year]

      Study the effectiveness of acupressure for nausea in all surgical patients undergoing surgery at the Lovisenberg Diakonale hospital. Effectiveness is monitored by the use of antiemetic drugs compared to a similar period before the wristbands were introduced as standard care at the hospital.

    Secondary Outcome Measures

    1. Reduction in use of antiemetic medication as a consequence of the introduction of acupressure wristband [One year]

      The study will be conducted with a one-group pretest-posttest design, measuring the consumption of antiemetics during a three month period before the implementation (baseline), and during the implementation period. The numbers of surgical operations will be the denominator in the two fractions. This secondary outcome might also be regarded as the primary outcome as the amount of antinausea medication is the major outcome measure

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Adults undergoing orthopaedic, general, and ear, nose, throat surgery at Lovisenberg Diaconal Hospital
    Exclusion Criteria:
    • Not fully verbal communication or informed consent not achieved

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Lovisenberg Diaconal Hospital Oslo Norway

    Sponsors and Collaborators

    • National Research Centre of Complementary and Alternative Medicine, Norway
    • Lovisenberg Diakonale Hospital

    Investigators

    • Principal Investigator: Arne Johan Norheim, PhD, University of Tromso

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01389570
    Other Study ID Numbers:
    • 2011/176
    First Posted:
    Jul 8, 2011
    Last Update Posted:
    Jul 18, 2011
    Last Verified:
    Jun 1, 2011
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 18, 2011