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

Pectus Excavatum Clinical Trial

Official title:

Does Acupressure Decrease Post-operative Nausea and Vomiting After the NUSS Procedure?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00892216
• Other study ID #: 05-188
• Status: Terminated
• Phase: N/A
• First received: April 30, 2009
• Last updated: April 7, 2015
• Start date: April 2005
• Est. completion date: October 2010

Study information

• Verified date: April 2015
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: October 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Funnel Chest
• Pectus Excavatum
• Postoperative Nausea and Vomiting

Intervention

Device:
• Acupressure (BioBand)
Band will remain on from 20 minutes before surgery until the end of the hospital stay.
• 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.

Locations

Country	Name	City	State
Canada	McMaster University Hospital, HHSC/Hamilton Health Sciences	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Twice a day for 5 days	No
Secondary	Possibility of decrease in VAS score and hospital stay when compared to control group.		Day 5	No