Postoperative Nausea/Vomiting and Acupressure (Acunausea)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by National Research Centre of Complementary and Alternative Medicine, Norway.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Lovisenberg Diakonale Hospital
Information provided by:
National Research Centre of Complementary and Alternative Medicine, Norway
ClinicalTrials.gov Identifier:
NCT01389570
First received: May 31, 2011
Last updated: July 15, 2011
Last verified: June 2011
  Purpose

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 Intervention Phase
Postoperative Nausea
Procedure: Acupressure wrist band
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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?

Resource links provided by NLM:


Further study details as provided by National Research Centre of Complementary and Alternative Medicine, Norway:

Primary Outcome Measures:
  • Effectiveness of acupressure for postoperative nausea in terms of less use of antiemetic drugs [ Time Frame: one year ] [ Designated as safety issue: Yes ]

    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:
  • Reduction in use of antiemetic medication as a consequence of the introduction of acupressure wristband [ Time Frame: One year ] [ Designated as safety issue: No ]

    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



Estimated Enrollment: 2000
Study Start Date: September 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Sea-Band Ltd

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.

  Eligibility

Ages Eligible for Study:   1 Year to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
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: NCT01389570

Contacts
Contact: Michael Howley, MD + 47 23 22 64 29 michael.howley@lds.no
Contact: Arne Johan Norheim, PhD +4748005535 arne.johan.norheim@hlkbb.no

Locations
Norway
Lovisenberg Diaconal Hospital Not yet recruiting
Oslo, Norway
Contact: Michael Howley, MD    + 47 23 22 64 29    michael.howley@lds.no   
Contact: Arne Johan Norheim, PhD    +4748005535    arne.johan.norheim@hlkbb.no   
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
  More Information

No publications provided

Responsible Party: Arne Johan Norheim, National Research Centre of Complementary and Alternative Medicine, Norway
ClinicalTrials.gov Identifier: NCT01389570     History of Changes
Other Study ID Numbers: 2011/176
Study First Received: May 31, 2011
Last Updated: July 15, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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

ClinicalTrials.gov processed this record on July 23, 2014