NCT01389570

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 8, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

July 18, 2011

Status Verified

June 1, 2011

Enrollment Period

3 months

First QC Date

May 31, 2011

Last Update Submit

July 15, 2011

Conditions

Outcome Measures

Primary Outcomes (1)

  • Effectiveness of acupressure for postoperative nausea in terms of less use of antiemetic drugs

    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.

    one year

Secondary Outcomes (1)

  • Reduction in use of antiemetic medication as a consequence of the introduction of acupressure wristband

    One year

Study Arms (1)

Acupressure wrist band

EXPERIMENTAL

The group receiving acupressure wrist band

Procedure: Acupressure wrist band

Interventions

Use of acupressure wristband during surgery Manufacturer; Pinnacle Ind Ltd, Rm 831 Thriving Ind Ctr, 26-38 Sha Tsui Rd, Tsuen Wan, Hong Kong

Also known as: Sea-Band Ltd
Acupressure wrist band

Eligibility Criteria

Age1 Year - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adults undergoing orthopaedic, general, and ear, nose, throat surgery at Lovisenberg Diaconal Hospital

You may not qualify if:

  • Not fully verbal communication or informed consent not achieved

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lovisenberg Diaconal Hospital

Oslo, Norway

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Study Officials

  • Arne Johan Norheim, PhD

    University of Tromso

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Howley, MD

CONTACT

Arne Johan Norheim, PhD

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 31, 2011

First Posted

July 8, 2011

Study Start

September 1, 2011

Primary Completion

December 1, 2011

Study Completion

June 1, 2012

Last Updated

July 18, 2011

Record last verified: 2011-06

Locations