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Does Acupressure Decrease Post-operative Nausea and Vomiting (PONV) After the Pectus Excavatum Correction (NUSS) Procedure?

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ClinicalTrials.gov Identifier: NCT00892216
Recruitment Status : Terminated (Not enough participants for study to be completed)
First Posted : May 4, 2009
Last Update Posted : April 8, 2015
Sponsor:
Collaborator:
Hamilton Health Sciences Corporation
Information provided by (Responsible Party):
McMaster University

Tracking Information
First Submitted Date  ICMJE April 30, 2009
First Posted Date  ICMJE May 4, 2009
Last Update Posted Date April 8, 2015
Study Start Date  ICMJE April 2005
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2009)
Relief of PONV. This effect will be evaluated in the PACU and then twice a day until discharge which is usually 5 days post-operative. Hospital score for nausea and vomiting will be used. [ Time Frame: Twice a day for 5 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2009)
Possibility of decrease in VAS score and hospital stay when compared to control group. [ Time Frame: Day 5 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Does Acupressure Decrease Post-operative Nausea and Vomiting (PONV) After the Pectus Excavatum Correction (NUSS) Procedure?
Official Title  ICMJE Does Acupressure Decrease Post-operative Nausea and Vomiting After the NUSS Procedure?
Brief Summary Post-operative nausea and vomiting (PONV) is not only unpleasant for patients but also can delay hospital discharge and increase cost of stay. In some cases, when severe vomiting occurs, pain scores seem to be increased. The overall incidence of PONV is 30% and increases to 79% in patients at high risk for this post-operative outcome. The NUSS procedure is considered to be a procedure with a high risk for the outcome of nausea and vomiting.
Detailed Description The rationale is to do a prospective study in patients who have been diagnosed with Pectus Excavatum and who are undergoing a NUSS procedure (pectus excavatum correction) and to evaluate the effect of Acupressure on the post-operative outcome of PONV in these patients. Also, to determine whether there are any secondary outcomes related to pain scores and length of hospital stay.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Pectus Excavatum
Intervention  ICMJE
  • Device: Acupressure (BioBand)
    Band will remain on from 20 minutes before surgery until the end of the hospital stay.
    Other Name: BioBand
  • Device: Acupressure (BioBand)
    Band will remain on from 20 minutes before surgery until the end of the hospital stay. The same band will be placed and turned so the beads face the corresponding point on the dorsal surface of the upper limb area.
    Other Name: BioBand
Study Arms  ICMJE
  • Experimental: Acupressure Band
    A band with bead attachment will be used to produce Acupressure and applied to the P6 (three fingers breath from the wrist crease on th ventral surface of the upper limb). The application will be done 20 minutes prior to anesthesia and explanation as to usage after surgery will be given. The patient of caregiver will apply pressure on the bead for three minutes and repeat this four times a day for the next five days. None of the protocol for prevention of PONV in this group of patients will be changed. The postoperative therapy for nausea and vomiting will be on a PRN (as required) basis. Nausea and vomiting scores and VAS scores for pain estimation will be carried out according to hospital protocol in the PACU amd twice a day thereafter for their period of stay in the hospital. The amount of analgesics and antiemetics used and the number of days spent in the hospital will be registered.
    Intervention: Device: Acupressure (BioBand)
  • Sham Comparator: Sham Acupressure
    The same band will be placed and turned so the beads face the corresponding point on the dorsal surface of the upper limb area.
    Intervention: Device: Acupressure (BioBand)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 1, 2009)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • age 8-40 years old
  • ASA 1-3
  • males & females

Exclusion Criteria:

  • local infection of the site - P6
  • acupuncture treatment within 8 weeks of the preoperative period
  • coagulopathy is a contraindication for Acupuncture but not Acupressure
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00892216
Other Study ID Numbers  ICMJE 05-188
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party McMaster University
Study Sponsor  ICMJE McMaster University
Collaborators  ICMJE Hamilton Health Sciences Corporation
Investigators  ICMJE
Principal Investigator: Meena Nandagopal, M.B.B.S. DLO, DARCS, FFARCS(I) Hamilton Health Sciences Corporation
PRS Account McMaster University
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP