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

Sponsor:	Hamilton Health Sciences Corporation
Information provided by:	McMaster University
ClinicalTrials.gov Identifier:	NCT00892216

Purpose

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.

Condition	Intervention
Pectus Excavatum	Device: Acupressure (BioBand)

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Does Acupressure Decrease Post-operative Nausea and Vomiting After the NUSS Procedure?

Resource links provided by NLM:

MedlinePlus related topics: Nausea and Vomiting

U.S. FDA Resources

Further study details as provided by McMaster University:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

Possibility of decrease in VAS score and hospital stay when compared to control group. [ Time Frame: Day 5 ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	April 2005
Study Completion Date:	October 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	Device: Acupressure (BioBand) Band will remain on from 20 minutes before surgery until the end of the hospital stay. Other Name: 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.	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

Arms

Assigned Interventions

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.

Device: Acupressure (BioBand)

Band will remain on from 20 minutes before surgery until the end of the hospital stay.

Other Name: 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.

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

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.

Eligibility

Ages Eligible for Study:	8 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00892216

Locations

Canada, Ontario
McMaster University Hospital, HHSC/Hamilton Health Sciences
Hamilton, Ontario, Canada, L8N 3Z5

Sponsors and Collaborators

Hamilton Health Sciences Corporation

Investigators

Principal Investigator:

Meena Nandagopal, M.B.B.S. DLO, DARCS, FFARCS(I)

Hamilton Health Sciences Corporation

More Information

No publications provided

Responsible Party:	Dr. Meena Nandagopal, Hamilton Health Sciences
ClinicalTrials.gov Identifier:	NCT00892216 History of Changes
Other Study ID Numbers:	05-188
Study First Received:	April 30, 2009
Last Updated:	October 14, 2010
Health Authority:	Canada: Ethics Review Committee

Keywords provided by McMaster University:

PONV
NUSS procedure
Acupressure
Pectus Excavatum

Additional relevant MeSH terms:

Funnel Chest
Vomiting
Postoperative Nausea and Vomiting
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Musculoskeletal Abnormalities

Congenital Abnormalities
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Nausea

ClinicalTrials.gov processed this record on February 09, 2012