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

This study has been terminated.
(Not enough participants for study to be completed)
Sponsor:
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00892216
First received: April 30, 2009
Last updated: October 14, 2010
Last verified: May 2009

April 30, 2009
October 14, 2010
April 2005
January 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00892216 on ClinicalTrials.gov Archive Site
Possibility of decrease in VAS score and hospital stay when compared to control group. [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Does Acupressure Decrease Post-operative Nausea and Vomiting (PONV) After the Pectus Excavatum Correction (NUSS) Procedure?
Does Acupressure Decrease Post-operative Nausea and Vomiting After the NUSS Procedure?

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Pectus Excavatum
  • 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
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
40
October 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
8 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00892216
05-188
No
Dr. Meena Nandagopal, Hamilton Health Sciences
Hamilton Health Sciences Corporation
Not Provided
Principal Investigator: Meena Nandagopal, M.B.B.S. DLO, DARCS, FFARCS(I) Hamilton Health Sciences Corporation
McMaster University
May 2009

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