Postoperative Nausea/Vomiting and Acupressure (Acunausea)
Primary Purpose
Postoperative Nausea
Status
Unknown status
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Acupressure wrist band
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Nausea
Eligibility 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
Sites / Locations
- Lovisenberg Diaconal Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Acupressure wrist band
Arm Description
The group receiving acupressure wrist band
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Reduction in use of antiemetic medication as a consequence of the introduction of acupressure wristband
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
Full Information
NCT ID
NCT01389570
First Posted
May 31, 2011
Last Updated
July 15, 2011
Sponsor
National Research Centre of Complementary and Alternative Medicine, Norway
Collaborators
Lovisenberg Diakonale Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01389570
Brief Title
Postoperative Nausea/Vomiting and Acupressure
Acronym
Acunausea
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 Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
June 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
National Research Centre of Complementary and Alternative Medicine, Norway
Collaborators
Lovisenberg Diakonale Hospital
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acupressure wrist band
Arm Type
Experimental
Arm Description
The group receiving acupressure wrist band
Intervention Type
Procedure
Intervention Name(s)
Acupressure wrist band
Other Intervention Name(s)
Sea-Band Ltd
Intervention Description
Use of acupressure wristband during surgery Manufacturer; Pinnacle Ind Ltd, Rm 831 Thriving Ind Ctr, 26-38 Sha Tsui Rd, Tsuen Wan, Hong Kong
Primary Outcome Measure Information:
Title
Effectiveness of acupressure for postoperative nausea in terms of less use of antiemetic drugs
Description
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.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Reduction in use of antiemetic medication as a consequence of the introduction of acupressure wristband
Description
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
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Howley, MD
Phone
+ 47 23 22 64 29
Email
michael.howley@lds.no
First Name & Middle Initial & Last Name or Official Title & Degree
Arne Johan Norheim, PhD
Phone
+4748005535
Email
arne.johan.norheim@hlkbb.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arne Johan Norheim, PhD
Organizational Affiliation
University of Tromso
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lovisenberg Diaconal Hospital
City
Oslo
Country
Norway
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Howley, MD
Phone
+ 47 23 22 64 29
Email
michael.howley@lds.no
First Name & Middle Initial & Last Name & Degree
Arne Johan Norheim, PhD
Phone
+4748005535
Email
arne.johan.norheim@hlkbb.no
12. IPD Sharing Statement
Learn more about this trial
Postoperative Nausea/Vomiting and Acupressure
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