Postoperative Nausea/Vomiting and Acupressure (Acunausea)

Postoperative Nausea/Vomiting and Acupressure Can Acupressure With Wristbands Reduce the Use of Antiemetics for the Treatment of Postoperative Nausea and Vomiting?

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Nausea
• Intervention / Treatment: Procedure: Acupressure wrist band

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 Type: Interventional
• Enrollment (Anticipated): 2000
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Michael Howley, MD; Phone Number: + 47 23 22 64 29; Email: michael.howley@lds.no
• Study Contact Backup: Name: Arne Johan Norheim, PhD; Phone Number: +4748005535; Email: arne.johan.norheim@hlkbb.no

Study Locations

• Norway
  • Oslo, Norway
    • Lovisenberg Diaconal Hospital
    • Contact: Michael Howley, MD; Phone Number: + 47 23 22 64 29; Email: michael.howley@lds.no
    • Contact: Arne Johan Norheim, PhD; Phone Number: +4748005535; Email: arne.johan.norheim@hlkbb.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	One year

Collaborators and Investigators

• Sponsor: National Research Centre of Complementary and Alternative Medicine, Norway
• Collaborators: Lovisenberg Diakonale Hospital
• Investigators: Principal Investigator: Arne Johan Norheim, PhD, University of Tromso

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Anticipated): December 1, 2011
• Study Completion (Anticipated): June 1, 2012

Study Registration Dates

• First Submitted: May 31, 2011
• First Submitted That Met QC Criteria: July 6, 2011
• First Posted (Estimate): July 8, 2011

Study Record Updates

• Last Update Posted (Estimate): July 18, 2011
• Last Update Submitted That Met QC Criteria: July 15, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting
• Other Study ID Numbers: 2011/176